This document describes a study that developed and optimized a pulsatile drug delivery system containing pantoprazole sodium using a 32 full factorial design approach. Six core tablets were initially prepared and evaluated. Amounts of microcrystalline cellulose (MCC) and sodium starch glycolate (SSG) were selected as independent variables in the factorial design to study their effects on tablet properties. The optimized core formulation (f3) was then coated with Eudragit S to produce pulsatile tablets. In vitro dissolution studies showed the coated tablets remained intact in acid media and released drug after reaching the intestine, indicating successful development of a pulsatile delivery system for pantoprazole sodium.
This document discusses the formulation and evaluation of bilayer tablets containing domperidone maleate. Bilayer tablets provide dual drug release and separation of incompatible substances. Domperidone is an antiemetic and used to treat nausea. Various pre-compression studies were conducted on formulations to optimize flow and compressibility. Tablets were developed using wet granulation and contained different polymers for immediate and sustained release layers. Post-compression testing included weight variation, hardness, friability, disintegration and dissolution studies. The project timeline included formulation, evaluation, stability studies and report preparation over 4 months.
Formulation and Evaluation of Microspheres Containing Aceclofenacpharmaindexing
This document describes research into formulating and evaluating microspheres containing the drug aceclofenac. Microspheres were prepared using hydroxypropyl methylcellulose (HPMC) and eudragit polymers via a solvent evaporation method. Infrared spectroscopy showed no chemical interactions between the drug and polymers. Drug entrapment efficiency was 72.32% for one formulation. In vitro drug release studies found 89.59% of the drug was released from one formulation over 12 hours. Scanning electron microscopy images showed the microspheres were spherical and smooth. The researchers concluded HPMC and eudragit are suitable carriers for preparing aceclofenac microspheres with improved bioavailability.
This document describes the development and evaluation of bilayer tablets containing capecitabine and ondansetron. The bilayer tablet uses Dual Release Drug Absorption System (DUREDAS) technology, providing sustained release of capecitabine in one layer and immediate release of ondansetron in another layer. Various excipients were evaluated to optimize the drug release profiles from each layer. Pre-formulation studies and tablet evaluations were conducted to develop a cost-effective bilayer tablet formulation for once-daily treatment of nausea and vomiting.
Formulation and evalution of sustained release matrix tabletsSanthosh Kumar
This document summarizes the formulation and evaluation of sustained release matrix tablets containing gliclazide. The objectives were to develop a once-daily tablet to reduce side effects and fluctuations in drug levels compared to immediate release tablets. Various polymers like HPMC K4M, HPMC K100LV, poloxamer 188, and PVP K30 were used to formulate sustained release matrix tablets by wet granulation. The tablets were evaluated for weight variation, hardness, friability, drug content and in vitro drug release over 20 hours. The optimized formulation showed comparable drug release to the innovator's product over the tested time period.
Design and in vitro evaluation of bilayer tablets of Tramadol hydrochloride f...ijperSS
This document describes the design and in vitro evaluation of bilayer tablets containing Tramadol Hydrochloride for biphasic drug release. Bilayer tablets were developed with an immediate release layer containing superdisintegrants and a sustained release layer containing hydrophilic polymers (HPMC) to provide both immediate and extended drug release. Seven bilayer tablet formulations were prepared by direct compression and evaluated for pre-compression and post-compression properties. In vitro dissolution studies showed formulation F6 released 99.5% of the drug over 12 hours from the sustained release layer, following Korsmeyer-Peppas kinetics. Accelerated stability studies found no changes in properties or drug release for F6 tablets over 3 months. The study
Development and evaluation of a novel twice daily cup core metformin hydrochl...SriramNagarajan19
The study was undertaken with an aim to formulate develop and evaluation of a novel twice daily core cup of Metformin hydrochloride(Antidiabetic drug) tablets using different grades and weight of HPMC polymers as release retarding agent. Granules were evaluated for tests Bulk density, tapped density, Hausner ratio before being punched as tablets. Tablets were tested for weight variation, thickness, hardness and friability as per official procedure. F-2 was found to be 73.90. From the above results and discussion it is concluded that formulation of Cup core tablet of containing Metformin hydrochloride HPMC K 4M & 215: 230 (in mg) can be taken as an ideal or optimized formulation of sustained release tablets for 12hour release as it fulfills all the requirements for sustained release tablet and our study encourages for the further clinical trials on this formulation. The core in cup tablets of Metformin hydrochloride were prepared by wet granulation method, they were evaluated for weight variation, friability, hardness, and thickness for all batches (F1 – F9). No significant difference was observed in the weight of individual tablets from the average weight. The weight variation tests were performed according to the procedure given in the pharmacopoeia. In a weight variation test, pharmacopoeial limit of tablet for percentage deviation is 5%. The average percentage deviation of all tablet formulation was found to be within the pharmacopoeial limit and hence all formulation passed the test for uniformity of weight.
This document discusses the formulation and evaluation of bilayer tablets containing domperidone maleate. Bilayer tablets provide dual drug release and separation of incompatible substances. Domperidone is an antiemetic and used to treat nausea. Various pre-compression studies were conducted on formulations to optimize flow and compressibility. Tablets were developed using wet granulation and contained different polymers for immediate and sustained release layers. Post-compression testing included weight variation, hardness, friability, disintegration and dissolution studies. The project timeline included formulation, evaluation, stability studies and report preparation over 4 months.
Formulation and Evaluation of Microspheres Containing Aceclofenacpharmaindexing
This document describes research into formulating and evaluating microspheres containing the drug aceclofenac. Microspheres were prepared using hydroxypropyl methylcellulose (HPMC) and eudragit polymers via a solvent evaporation method. Infrared spectroscopy showed no chemical interactions between the drug and polymers. Drug entrapment efficiency was 72.32% for one formulation. In vitro drug release studies found 89.59% of the drug was released from one formulation over 12 hours. Scanning electron microscopy images showed the microspheres were spherical and smooth. The researchers concluded HPMC and eudragit are suitable carriers for preparing aceclofenac microspheres with improved bioavailability.
This document describes the development and evaluation of bilayer tablets containing capecitabine and ondansetron. The bilayer tablet uses Dual Release Drug Absorption System (DUREDAS) technology, providing sustained release of capecitabine in one layer and immediate release of ondansetron in another layer. Various excipients were evaluated to optimize the drug release profiles from each layer. Pre-formulation studies and tablet evaluations were conducted to develop a cost-effective bilayer tablet formulation for once-daily treatment of nausea and vomiting.
Formulation and evalution of sustained release matrix tabletsSanthosh Kumar
This document summarizes the formulation and evaluation of sustained release matrix tablets containing gliclazide. The objectives were to develop a once-daily tablet to reduce side effects and fluctuations in drug levels compared to immediate release tablets. Various polymers like HPMC K4M, HPMC K100LV, poloxamer 188, and PVP K30 were used to formulate sustained release matrix tablets by wet granulation. The tablets were evaluated for weight variation, hardness, friability, drug content and in vitro drug release over 20 hours. The optimized formulation showed comparable drug release to the innovator's product over the tested time period.
Design and in vitro evaluation of bilayer tablets of Tramadol hydrochloride f...ijperSS
This document describes the design and in vitro evaluation of bilayer tablets containing Tramadol Hydrochloride for biphasic drug release. Bilayer tablets were developed with an immediate release layer containing superdisintegrants and a sustained release layer containing hydrophilic polymers (HPMC) to provide both immediate and extended drug release. Seven bilayer tablet formulations were prepared by direct compression and evaluated for pre-compression and post-compression properties. In vitro dissolution studies showed formulation F6 released 99.5% of the drug over 12 hours from the sustained release layer, following Korsmeyer-Peppas kinetics. Accelerated stability studies found no changes in properties or drug release for F6 tablets over 3 months. The study
Development and evaluation of a novel twice daily cup core metformin hydrochl...SriramNagarajan19
The study was undertaken with an aim to formulate develop and evaluation of a novel twice daily core cup of Metformin hydrochloride(Antidiabetic drug) tablets using different grades and weight of HPMC polymers as release retarding agent. Granules were evaluated for tests Bulk density, tapped density, Hausner ratio before being punched as tablets. Tablets were tested for weight variation, thickness, hardness and friability as per official procedure. F-2 was found to be 73.90. From the above results and discussion it is concluded that formulation of Cup core tablet of containing Metformin hydrochloride HPMC K 4M & 215: 230 (in mg) can be taken as an ideal or optimized formulation of sustained release tablets for 12hour release as it fulfills all the requirements for sustained release tablet and our study encourages for the further clinical trials on this formulation. The core in cup tablets of Metformin hydrochloride were prepared by wet granulation method, they were evaluated for weight variation, friability, hardness, and thickness for all batches (F1 – F9). No significant difference was observed in the weight of individual tablets from the average weight. The weight variation tests were performed according to the procedure given in the pharmacopoeia. In a weight variation test, pharmacopoeial limit of tablet for percentage deviation is 5%. The average percentage deviation of all tablet formulation was found to be within the pharmacopoeial limit and hence all formulation passed the test for uniformity of weight.
The document summarizes the development of an extended release formulation of bupropion hydrochloride tablets. The objectives were to develop a stable, cost-effective ER formulation and compare it to marketed products. Various ER tablet formulations were prepared using different concentrations of coating polymers and evaluated for drug release. Formulations F9 and F10, which used 8% coating of ethylcellulose 15cps, showed comparable release to the reference product over 16 hours. The developed formulation met the objectives of providing a once-daily ER tablet for bupropion hydrochloride.
Formulation and evaluation of metformin and rosuvastatin bilayered tabletsSriramNagarajan17
This document describes the formulation and evaluation of bilayer tablets containing metformin hydrochloride as the sustained release layer and rosuvastatin as the immediate release layer. Various formulations of each layer were prepared using different polymers, excipients, and manufacturing methods. The metformin layer was prepared by wet granulation while the rosuvastatin layer used direct compression. Physicochemical properties of granules and tablets were evaluated. Standard calibration curves were developed for both drugs to enable drug content analysis. The optimized formulations demonstrated desired drug release profiles with the metformin layer providing sustained release over 12 hours and the rosuvastatin layer releasing completely within 1 hour.
1. The document describes the formulation and evaluation of prolonged release metformin hydrochloride tablets. Tablets were prepared by direct compression and wet granulation methods using polymers like Polyox-303 to sustain the release of the drug.
2. Tablets were evaluated for pre-compression and post-compression parameters. In-vitro dissolution and stability studies showed that the formulations had a controlled release of the drug over an extended period of time.
3. The optimized formulation was stable for 1 month under accelerated conditions as per ICH guidelines.
formulation and evaluation of microbeadsgurleen kaur
Microencapsulation has been employed to sustain the drug release, reduce or eliminate drug related adverse effects, dose intake and improve the bioavailability inspite drug undergo extensive first pass metabolism ultimately improve the compliance in pharmacotherapy of inflammation and pain.
Microencapsulation by ionotropic gelation technique is one of the widely used method for preparation of calcium alginate beads which has ability to form gels reaction with calcium salts .
Microencapsulation has been employed to sustain the drug release, reduce or eliminate drug related adverse effects, dose intake and improve the bioavailability inspite drug undergo extensive first pass metabolism ultimately improve the compliance in pharmacotherapy of inflammation and pain.
Microencapsulation by ionotropic gelation technique is one of the widely used method for preparation of calcium alginate beads which has ability to form gels reaction with calcium salts .
Aim: This diploma thesis focused on the study of the influence of two types of high-shear
mixers as well as the effect of poly(meth)acrylate concentrations on the properties of
prepared granules and consequently matrix tablets.
Methods: Caffeine was employed as the model drug and matrix tablets were prepared via
the wet granulation process using two different high-shear mixers either Stephan UMC5 or
Rotolab mixer. Eudragit® NM 30D was used in various concentrations as a wet granulation
agent for time controlled drug release with low permeability and pH independent swelling.
In addition, lactose monohydrate was added as indifferent soluble filler, magnesium
stearate served as the antiadhesive excipient and colloidal silica was added for flowability
improvement. Matrix tablets were evaluated for mass, content and dosage uniformity,
uniformity of dosage units, friability, hardness and dissolution according to Ph. Eur.
Results - Conclusions: All prepared tablets exhibited sustained drug release. The
employment of different mixers for sustained matrix tablets preparation did not
significantly influence the release profile of caffeine (Eudragit® NM concentrations 9-
14%), except when the lower Eudragit® NM concentration (7%) was used for granulation.
Furthermore, Eudragit® NM concentrations (7 – 14% per tablet) did not significantly affect
the release profile of caffeine from matrix tablets, neither in the Stephan UMC5 nor the
Rotolab mixer.
Formulation and evaluation of bi-layered floating tablets of metformin and te...SriramNagarajan17
The document describes the formulation and evaluation of bi-layer floating tablets containing metformin and telmisartan. Metformin was formulated as a sustained release layer using polymers like guar gum and xanthan gum, while telmisartan was formulated as an immediate release layer using superdisintegrants. Various pre-compression and post-compression evaluation tests were conducted on the powder blends and tablets. In vitro drug release studies showed that formulation F3 provided sustained release of metformin for up to 12 hours while F5 formulation released 100.6% of telmisartan within 30 minutes, indicating their suitability as a bi-layer floating tablet system.
ABSTRACT
Hyperglycemia is the technical term for high blood glucose (sugar). It
happens when the body has too little or not enough insulin or when the
body can‘t use insulin properly. The main objective of the present
research work was to develop a bilayer tablet of immediate release
Pioglitazone and controlled release Metformin Hydrochloride, which is
used as an Anti-hyperglycemic agent. Metformin Hydrochloride has
biological half-life nearly about 6 hours, so, an attempt was made in
the direction of preparation and optimization of a combination of
sustained release and immediate release in a single tablet. In controlled
release layer natural gums like xanthum gum, gum trgacanth and guar
gum were used as retarding materials and in immediate release laye
croscarmellose sodium was used as a superdisintegrent to give the faster release of
pioglitazone. The tablets were prepared by wet granulation method and by direct
compression. Granules were evaluated for precompression parameters and the tablets were
evaluated for post compression parameters.
Key Words: Bilayer tablets, Metformin Hydrochloride, pioglitazone, xanthum gum, guar
gum, gum tragacanth and crosscarmellose sodium.
Development and evaluation of xyloglucan matrix release tabs contaning glipizidesukesh
The document describes a research project that developed and evaluated matrix release tablets containing the drug glipizide using xyloglucan as a polymer. Xyloglucan was extracted from tamarind kernels and used to prepare different tablet formulations. Tablets were evaluated for dissolution, drug release, and other parameters. The best formulation was F1, which released 99% of the drug in a prolonged manner and could be used for extended release of glipizide.
Design and Development of Effervescent Floating Tablet Dapagliflozinijtsrd
The objective of the present study was to formulate and evaluate Effervescent Floating Tablet of Dapagliflozin for the treatment of antidepressant agent. Tablets were prepared by direct compression using directly compressible polymers such as HPMC K4M, and Carbopol 934 were evaluated for drug excipient compatibility, density, buoyancy test, swelling study, drug content and In Vitro release profile. Sodium bicarbonate and citric acid were used producing effervescent base for buoyancy of tablets. Analysis of drug release from tablet indicates drug release by zero order, first order rate kinetics. No significant change was observed in physical appearance, drug content, floatability or in vitro dissolution pattern after storage at 450C 750C RH for three months. Samadhan Mali | Shweta Gedam | Swati Talele | Anil Jadhav "Design and Development of Effervescent Floating Tablet Dapagliflozin" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-5 , August 2020, URL: https://www.ijtsrd.com/papers/ijtsrd31674.pdf Paper Url :https://www.ijtsrd.com/pharmacy/pharmaceutics/31674/design-and-development-of-effervescent-floating-tablet-dapagliflozin/samadhan-mali
Effervescent technique in development of floating tablets for antiviral drugsSriramNagarajan19
The purpose of this investigation was to prepare a regiospesific drug delivery system of Stavudine. Floating tablets of Stavudine were prepared by direct compression method employing different concentration of HPMC K15M by effervescent technique. Sodium bicarbonate was incorporated as a gas-generating agent. The floating tablets were evaluated for uniformity of weight, hardness, friability, drug content, swelling studies, in vitro buoyancy and dissolution studies. The effect of different concentration of HPMC K15M on drug release profile and floating properties was investigated. The prepared tablets exhibited satisfactory physico-chemical characteristics. All the prepared batches showed good in vitro buoyancy. The tablet swelled radially and axially during in vitro buoyancy studies. It was observed that the tablet remained buoyant for more than 12 hours. Increased in the HPMC K15M level, decreased the floating lag time but tablets floated for longer duration. The formulation with 1:1 drug: Polymer ratios were found to float for longer duration as compared with other formulations containing HPMC K15M. The drug release from the tablets was sufficiently sustained and non-Fickian transport of the drug from tablets was confirmed.
Development and in vitro evaluation of sustained release formulation of telmi...SriramNagarajan18
This document describes the development and in vitro evaluation of sustained release tablets of telmisartan hydrochloride. Various polymers including Eudragit RL 100, guar gum, and ethyl cellulose were used to formulate the sustained release matrix tablets. Tablets were prepared by direct compression and evaluated for physicochemical properties and in vitro drug release over 12 hours. The optimized formulation (F6) containing Eudragit RL 100 showed desired drug release of 96.10% over 12 hours and followed zero-order release kinetics. The document aims to develop a sustained release formulation of telmisartan that can maintain therapeutic drug levels for over 12 hours with once-daily dosing.
Formulation and evaluation of tramadol using pulsincap technologySriramNagarajan18
This document describes the formulation and evaluation of tramadol pulsincaps using pulsincap technology for colon-specific delivery. Tramadol granules were prepared by blending the drug with polymers like HPMC K4M and ethyl cellulose. Hard gelatin capsules were treated with formaldehyde to make them insoluble in the stomach and small intestine. The granules were filled into the treated capsule bodies and sealed with a hydrogel plug. The formulations were evaluated for flow properties, drug content, and in vitro dissolution. Dissolution studies showed the formulations released drug in a pulsatile manner with a lag time followed by rapid release. Formulation F3 with 30% polymer showed the highest drug release of 96
Formulation and evaluation of Repaglinide biphasic mini tabletsSriramNagarajan18
This document summarizes the formulation and evaluation of biphasic mini tablets containing repaglinide, an anti-diabetic drug. Immediate release mini tablets were produced using superdisintegrants like sodium starch glycolate and cross povidone. Sustained release mini tablets were developed using polymers like HPMC K100M and ethyl cellulose. The mini tablets were characterized for properties like hardness, friability and drug release. The optimized immediate release formulation showed 99.7% drug release within 15 minutes using sodium starch glycolate. The sustained release formulation using HPMC K100M and ethyl cellulose released drug over 10 hours as desired. The mini tablets were filled into capsules to provide biphasic
The three main rate limiting steps in drug absorption from oral solid dosage forms are disintegration, dissolution, and gastric emptying. Disintegration involves the breakdown of the solid dosage form into smaller particles so that the drug can be released. Dissolution is the process by which the drug becomes dissolved in water to be absorbed. Gastric emptying determines how quickly the drug formulation moves from the stomach into the intestines, where most absorption occurs. Several drug and formulation properties can impact these steps and influence overall drug absorption.
Formulation of an anti-inflammatory drug as fast dissolving tabletsIOSR Journals
The demand for mouth dissolving tablets has been growing during the last decade especially for elderly and children who have difficulties in swallowing. Ketorolac tromethamine is an effective anti-inflammatory agent that has been extensively used for the prevention of pain and inflammation associated with a wide variety of reasons. This study was aimed to form Ketorolac tromethamine mouth dissolving tablets by direct compression using superdisintegratants as crospovidone (CP) ,crosscarmellose sodium (CCS), and sodium starch glycolate (SSG) at concentrations of 3%, 6%, 9%, and 12%. The physical mixtures of the drug and the used excipients were evaluated for their micromeretric properties such as angle of repose, particle size, Hausner's ratio and % compressibility. Also, FTIR spectroscopy and DSC calorimetry were performed to indicate any possible interaction between the drug with the used excipients.All the prepared tablets were evaluated for their weight variation, thickness, hardness, wetting time, and disintegration time. Also in-vitro release study was done for all the prepared tablets using distilled deionized water as dissolution medium at 37.5± 0.5 c˚. Based on in-vitro release study and stability studies, G5 (contained 3% CCS) was found to be the promising formulae and subjected to further studies.
The document summarizes the design and statistical optimization of a pulsatile delivery system containing pantoprazole sodium. Key points include:
- The aim is to develop a pulsatile drug release tablet for pantoprazole sodium using MCC, CCS, and SSG to achieve a lag time of 5 hours followed by immediate drug release.
- A 32 factorial design is used to optimize the formulation. Preliminary studies evaluate formulations with varying levels of MCC, CCS, and SSG.
- Tablets are evaluated for pre-compression parameters, drug content, disintegration time, and dissolution profile in pH 6.8 buffer.
- The best formulation from preliminary studies will be selected for
This document outlines preformulation studies conducted on the drug metronidazole, including characterization of its physical properties, solubility, stability, and compatibility with excipients. Key aspects that were evaluated include particle size, bulk density, angle of repose, pH, partition coefficient, stability under various conditions like temperature, humidity and light. Drug-excipient compatibility was also studied by storing mixtures at elevated temperature and observing for physical or chemical changes. The goal of these studies is to understand the drug's characteristics and behavior to aid in rational formulation design and selection of appropriate excipients and storage conditions.
This document describes the development and validation of a stability-indicating high-performance thin layer chromatography (HPTLC) method for the analysis of modafinil, both as a bulk drug and in tablet formulations. The method utilizes silica gel plates with an ethyl acetate, acetone and methanol mobile phase. Modafinil demonstrates good linearity, precision, accuracy and robustness within the method validation parameters. The method is also shown to distinguish modafinil from its degradation products formed under various stress conditions like acid and base hydrolysis, oxidation, photolysis and heat. The developed HPTLC method can be applied for the quantitative analysis and identification of modafinil in pharmaceutical formulations.
Development and pharmaceutical evaluation of oral fast dissolving thin film o...Madiha Mushtaque
The current study focused on the development, optimization and pharmaceutical evaluation of a mouth dissolving film of Escitalopram 5mg. The designing and optimization of the formulations have been carried out through
Design-Expert ® Ver. 9, using central composite response surface methodology. The software generated six optimized
formulations have been fabricated via solvent casting method incorporated with HPMC and PEG 400 as Plasticizer. The
developed formulations were assessed for various quality attributes including weight variation, drug-excipients
interaction, dryness/ tack test, thickness, percent elongation, swelling index, disintegration, folding endurance, surface
pH, content uniformity, assay, moisture uptake, stability, and organoleptic properties. A validated spectrophotometric
method has been used to ascertain drug content. The formulations were subjected for stability studies for six months in
accordance with ICH accelerated stability studies guidelines. No stability issue has been observed. All the test
formulations have shown satisfactory in vitro release of escitalopram whereas most promising results have been
exhibited by F5 and F6 formulations. The study concluded that a unique, novel, safe and stable formulation of oral fast
dissolving thin films of escitalopram can be formulated with ease. The preparation method was simple and reproducible
with scale-up tendency so that it can fulfill the need of the commercial manufacturing process.
The document summarizes the development of an extended release formulation of bupropion hydrochloride tablets. The objectives were to develop a stable, cost-effective ER formulation and compare it to marketed products. Various ER tablet formulations were prepared using different concentrations of coating polymers and evaluated for drug release. Formulations F9 and F10, which used 8% coating of ethylcellulose 15cps, showed comparable release to the reference product over 16 hours. The developed formulation met the objectives of providing a once-daily ER tablet for bupropion hydrochloride.
Formulation and evaluation of metformin and rosuvastatin bilayered tabletsSriramNagarajan17
This document describes the formulation and evaluation of bilayer tablets containing metformin hydrochloride as the sustained release layer and rosuvastatin as the immediate release layer. Various formulations of each layer were prepared using different polymers, excipients, and manufacturing methods. The metformin layer was prepared by wet granulation while the rosuvastatin layer used direct compression. Physicochemical properties of granules and tablets were evaluated. Standard calibration curves were developed for both drugs to enable drug content analysis. The optimized formulations demonstrated desired drug release profiles with the metformin layer providing sustained release over 12 hours and the rosuvastatin layer releasing completely within 1 hour.
1. The document describes the formulation and evaluation of prolonged release metformin hydrochloride tablets. Tablets were prepared by direct compression and wet granulation methods using polymers like Polyox-303 to sustain the release of the drug.
2. Tablets were evaluated for pre-compression and post-compression parameters. In-vitro dissolution and stability studies showed that the formulations had a controlled release of the drug over an extended period of time.
3. The optimized formulation was stable for 1 month under accelerated conditions as per ICH guidelines.
formulation and evaluation of microbeadsgurleen kaur
Microencapsulation has been employed to sustain the drug release, reduce or eliminate drug related adverse effects, dose intake and improve the bioavailability inspite drug undergo extensive first pass metabolism ultimately improve the compliance in pharmacotherapy of inflammation and pain.
Microencapsulation by ionotropic gelation technique is one of the widely used method for preparation of calcium alginate beads which has ability to form gels reaction with calcium salts .
Microencapsulation has been employed to sustain the drug release, reduce or eliminate drug related adverse effects, dose intake and improve the bioavailability inspite drug undergo extensive first pass metabolism ultimately improve the compliance in pharmacotherapy of inflammation and pain.
Microencapsulation by ionotropic gelation technique is one of the widely used method for preparation of calcium alginate beads which has ability to form gels reaction with calcium salts .
Aim: This diploma thesis focused on the study of the influence of two types of high-shear
mixers as well as the effect of poly(meth)acrylate concentrations on the properties of
prepared granules and consequently matrix tablets.
Methods: Caffeine was employed as the model drug and matrix tablets were prepared via
the wet granulation process using two different high-shear mixers either Stephan UMC5 or
Rotolab mixer. Eudragit® NM 30D was used in various concentrations as a wet granulation
agent for time controlled drug release with low permeability and pH independent swelling.
In addition, lactose monohydrate was added as indifferent soluble filler, magnesium
stearate served as the antiadhesive excipient and colloidal silica was added for flowability
improvement. Matrix tablets were evaluated for mass, content and dosage uniformity,
uniformity of dosage units, friability, hardness and dissolution according to Ph. Eur.
Results - Conclusions: All prepared tablets exhibited sustained drug release. The
employment of different mixers for sustained matrix tablets preparation did not
significantly influence the release profile of caffeine (Eudragit® NM concentrations 9-
14%), except when the lower Eudragit® NM concentration (7%) was used for granulation.
Furthermore, Eudragit® NM concentrations (7 – 14% per tablet) did not significantly affect
the release profile of caffeine from matrix tablets, neither in the Stephan UMC5 nor the
Rotolab mixer.
Formulation and evaluation of bi-layered floating tablets of metformin and te...SriramNagarajan17
The document describes the formulation and evaluation of bi-layer floating tablets containing metformin and telmisartan. Metformin was formulated as a sustained release layer using polymers like guar gum and xanthan gum, while telmisartan was formulated as an immediate release layer using superdisintegrants. Various pre-compression and post-compression evaluation tests were conducted on the powder blends and tablets. In vitro drug release studies showed that formulation F3 provided sustained release of metformin for up to 12 hours while F5 formulation released 100.6% of telmisartan within 30 minutes, indicating their suitability as a bi-layer floating tablet system.
ABSTRACT
Hyperglycemia is the technical term for high blood glucose (sugar). It
happens when the body has too little or not enough insulin or when the
body can‘t use insulin properly. The main objective of the present
research work was to develop a bilayer tablet of immediate release
Pioglitazone and controlled release Metformin Hydrochloride, which is
used as an Anti-hyperglycemic agent. Metformin Hydrochloride has
biological half-life nearly about 6 hours, so, an attempt was made in
the direction of preparation and optimization of a combination of
sustained release and immediate release in a single tablet. In controlled
release layer natural gums like xanthum gum, gum trgacanth and guar
gum were used as retarding materials and in immediate release laye
croscarmellose sodium was used as a superdisintegrent to give the faster release of
pioglitazone. The tablets were prepared by wet granulation method and by direct
compression. Granules were evaluated for precompression parameters and the tablets were
evaluated for post compression parameters.
Key Words: Bilayer tablets, Metformin Hydrochloride, pioglitazone, xanthum gum, guar
gum, gum tragacanth and crosscarmellose sodium.
Development and evaluation of xyloglucan matrix release tabs contaning glipizidesukesh
The document describes a research project that developed and evaluated matrix release tablets containing the drug glipizide using xyloglucan as a polymer. Xyloglucan was extracted from tamarind kernels and used to prepare different tablet formulations. Tablets were evaluated for dissolution, drug release, and other parameters. The best formulation was F1, which released 99% of the drug in a prolonged manner and could be used for extended release of glipizide.
Design and Development of Effervescent Floating Tablet Dapagliflozinijtsrd
The objective of the present study was to formulate and evaluate Effervescent Floating Tablet of Dapagliflozin for the treatment of antidepressant agent. Tablets were prepared by direct compression using directly compressible polymers such as HPMC K4M, and Carbopol 934 were evaluated for drug excipient compatibility, density, buoyancy test, swelling study, drug content and In Vitro release profile. Sodium bicarbonate and citric acid were used producing effervescent base for buoyancy of tablets. Analysis of drug release from tablet indicates drug release by zero order, first order rate kinetics. No significant change was observed in physical appearance, drug content, floatability or in vitro dissolution pattern after storage at 450C 750C RH for three months. Samadhan Mali | Shweta Gedam | Swati Talele | Anil Jadhav "Design and Development of Effervescent Floating Tablet Dapagliflozin" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-5 , August 2020, URL: https://www.ijtsrd.com/papers/ijtsrd31674.pdf Paper Url :https://www.ijtsrd.com/pharmacy/pharmaceutics/31674/design-and-development-of-effervescent-floating-tablet-dapagliflozin/samadhan-mali
Effervescent technique in development of floating tablets for antiviral drugsSriramNagarajan19
The purpose of this investigation was to prepare a regiospesific drug delivery system of Stavudine. Floating tablets of Stavudine were prepared by direct compression method employing different concentration of HPMC K15M by effervescent technique. Sodium bicarbonate was incorporated as a gas-generating agent. The floating tablets were evaluated for uniformity of weight, hardness, friability, drug content, swelling studies, in vitro buoyancy and dissolution studies. The effect of different concentration of HPMC K15M on drug release profile and floating properties was investigated. The prepared tablets exhibited satisfactory physico-chemical characteristics. All the prepared batches showed good in vitro buoyancy. The tablet swelled radially and axially during in vitro buoyancy studies. It was observed that the tablet remained buoyant for more than 12 hours. Increased in the HPMC K15M level, decreased the floating lag time but tablets floated for longer duration. The formulation with 1:1 drug: Polymer ratios were found to float for longer duration as compared with other formulations containing HPMC K15M. The drug release from the tablets was sufficiently sustained and non-Fickian transport of the drug from tablets was confirmed.
Development and in vitro evaluation of sustained release formulation of telmi...SriramNagarajan18
This document describes the development and in vitro evaluation of sustained release tablets of telmisartan hydrochloride. Various polymers including Eudragit RL 100, guar gum, and ethyl cellulose were used to formulate the sustained release matrix tablets. Tablets were prepared by direct compression and evaluated for physicochemical properties and in vitro drug release over 12 hours. The optimized formulation (F6) containing Eudragit RL 100 showed desired drug release of 96.10% over 12 hours and followed zero-order release kinetics. The document aims to develop a sustained release formulation of telmisartan that can maintain therapeutic drug levels for over 12 hours with once-daily dosing.
Formulation and evaluation of tramadol using pulsincap technologySriramNagarajan18
This document describes the formulation and evaluation of tramadol pulsincaps using pulsincap technology for colon-specific delivery. Tramadol granules were prepared by blending the drug with polymers like HPMC K4M and ethyl cellulose. Hard gelatin capsules were treated with formaldehyde to make them insoluble in the stomach and small intestine. The granules were filled into the treated capsule bodies and sealed with a hydrogel plug. The formulations were evaluated for flow properties, drug content, and in vitro dissolution. Dissolution studies showed the formulations released drug in a pulsatile manner with a lag time followed by rapid release. Formulation F3 with 30% polymer showed the highest drug release of 96
Formulation and evaluation of Repaglinide biphasic mini tabletsSriramNagarajan18
This document summarizes the formulation and evaluation of biphasic mini tablets containing repaglinide, an anti-diabetic drug. Immediate release mini tablets were produced using superdisintegrants like sodium starch glycolate and cross povidone. Sustained release mini tablets were developed using polymers like HPMC K100M and ethyl cellulose. The mini tablets were characterized for properties like hardness, friability and drug release. The optimized immediate release formulation showed 99.7% drug release within 15 minutes using sodium starch glycolate. The sustained release formulation using HPMC K100M and ethyl cellulose released drug over 10 hours as desired. The mini tablets were filled into capsules to provide biphasic
The three main rate limiting steps in drug absorption from oral solid dosage forms are disintegration, dissolution, and gastric emptying. Disintegration involves the breakdown of the solid dosage form into smaller particles so that the drug can be released. Dissolution is the process by which the drug becomes dissolved in water to be absorbed. Gastric emptying determines how quickly the drug formulation moves from the stomach into the intestines, where most absorption occurs. Several drug and formulation properties can impact these steps and influence overall drug absorption.
Formulation of an anti-inflammatory drug as fast dissolving tabletsIOSR Journals
The demand for mouth dissolving tablets has been growing during the last decade especially for elderly and children who have difficulties in swallowing. Ketorolac tromethamine is an effective anti-inflammatory agent that has been extensively used for the prevention of pain and inflammation associated with a wide variety of reasons. This study was aimed to form Ketorolac tromethamine mouth dissolving tablets by direct compression using superdisintegratants as crospovidone (CP) ,crosscarmellose sodium (CCS), and sodium starch glycolate (SSG) at concentrations of 3%, 6%, 9%, and 12%. The physical mixtures of the drug and the used excipients were evaluated for their micromeretric properties such as angle of repose, particle size, Hausner's ratio and % compressibility. Also, FTIR spectroscopy and DSC calorimetry were performed to indicate any possible interaction between the drug with the used excipients.All the prepared tablets were evaluated for their weight variation, thickness, hardness, wetting time, and disintegration time. Also in-vitro release study was done for all the prepared tablets using distilled deionized water as dissolution medium at 37.5± 0.5 c˚. Based on in-vitro release study and stability studies, G5 (contained 3% CCS) was found to be the promising formulae and subjected to further studies.
The document summarizes the design and statistical optimization of a pulsatile delivery system containing pantoprazole sodium. Key points include:
- The aim is to develop a pulsatile drug release tablet for pantoprazole sodium using MCC, CCS, and SSG to achieve a lag time of 5 hours followed by immediate drug release.
- A 32 factorial design is used to optimize the formulation. Preliminary studies evaluate formulations with varying levels of MCC, CCS, and SSG.
- Tablets are evaluated for pre-compression parameters, drug content, disintegration time, and dissolution profile in pH 6.8 buffer.
- The best formulation from preliminary studies will be selected for
This document outlines preformulation studies conducted on the drug metronidazole, including characterization of its physical properties, solubility, stability, and compatibility with excipients. Key aspects that were evaluated include particle size, bulk density, angle of repose, pH, partition coefficient, stability under various conditions like temperature, humidity and light. Drug-excipient compatibility was also studied by storing mixtures at elevated temperature and observing for physical or chemical changes. The goal of these studies is to understand the drug's characteristics and behavior to aid in rational formulation design and selection of appropriate excipients and storage conditions.
This document describes the development and validation of a stability-indicating high-performance thin layer chromatography (HPTLC) method for the analysis of modafinil, both as a bulk drug and in tablet formulations. The method utilizes silica gel plates with an ethyl acetate, acetone and methanol mobile phase. Modafinil demonstrates good linearity, precision, accuracy and robustness within the method validation parameters. The method is also shown to distinguish modafinil from its degradation products formed under various stress conditions like acid and base hydrolysis, oxidation, photolysis and heat. The developed HPTLC method can be applied for the quantitative analysis and identification of modafinil in pharmaceutical formulations.
Development and pharmaceutical evaluation of oral fast dissolving thin film o...Madiha Mushtaque
The current study focused on the development, optimization and pharmaceutical evaluation of a mouth dissolving film of Escitalopram 5mg. The designing and optimization of the formulations have been carried out through
Design-Expert ® Ver. 9, using central composite response surface methodology. The software generated six optimized
formulations have been fabricated via solvent casting method incorporated with HPMC and PEG 400 as Plasticizer. The
developed formulations were assessed for various quality attributes including weight variation, drug-excipients
interaction, dryness/ tack test, thickness, percent elongation, swelling index, disintegration, folding endurance, surface
pH, content uniformity, assay, moisture uptake, stability, and organoleptic properties. A validated spectrophotometric
method has been used to ascertain drug content. The formulations were subjected for stability studies for six months in
accordance with ICH accelerated stability studies guidelines. No stability issue has been observed. All the test
formulations have shown satisfactory in vitro release of escitalopram whereas most promising results have been
exhibited by F5 and F6 formulations. The study concluded that a unique, novel, safe and stable formulation of oral fast
dissolving thin films of escitalopram can be formulated with ease. The preparation method was simple and reproducible
with scale-up tendency so that it can fulfill the need of the commercial manufacturing process.
Formulation and evaluation of controlled drug release naproxen pelletsSriramNagarajan18
This document summarizes research on the formulation and evaluation of controlled-release naproxen pellets. Naproxen pellets were produced via extrusion-spheronization and coated for controlled release. Various formulations with different ratios of ingredients were tested. Formulation F9 was found to have the optimal drug release profile and stability. The pellets were evaluated for properties like particle size, drug content, and in vitro drug release, which followed first order kinetics. Controlled-release naproxen pellets could provide benefits over immediate-release formulations.
DESIGN AND EVALUATION OF BILAYER SUSTAINED RELEASE ANTI-HYPERTENSIVE TABLETIshwarJadhav4
The document summarizes the design and evaluation of a bilayer sustained release tablet containing the antihypertensive drug propranolol. Key points include:
- Bilayer tablets contain two layers, one for immediate release and one for sustained release, to provide both an initial dose and prolonged maintenance dose.
- The objective is to develop a stable bilayer tablet formulation to improve drug delivery, therapeutic effects, safety, and patient compliance for propranolol.
- Preformulation studies are conducted to characterize propranolol and evaluate powder flow properties. Tablet formulations are developed using different polymers for the sustained release layer and evaluated for dissolution and drug release.
The document summarizes research on developing enteric-coated tablets of the drug Ramipril to improve its bioavailability and reduce side effects. Immediate-release core tablets were prepared with different superdisintegrants and coated with pH-sensitive polymers Eudragit L-100 and Cellulose Acetate Pthalate. Tablets coated with 9% Cellulose Acetate Pthalate at a coating ratio of 60% triethyl citrate and IPA:DCM 60:40 provided the highest drug release profile in dissolution testing. The optimized formulation aims to protect Ramipril from degradation in the stomach and provide rapid drug release in the intestines.
Formulation and evaluation of microspheres with aceclofenacSagar Savale
Aceclofenac is an analgesic and anti-inflammatory drug that reduces fever, pain, and inflammation in rheumatoid
arthritis, osteoarthritis and ankylosing spondylitis. Aceclofenac has higher anti-inflammatory action than
conventional NSAIDs. Development of microspheres is a promising technology for controlled release and drug
targeting. Various types of microspheres such as bio-adhesive, magnetic, floating, radioactive and polymeric
microspheres are developed for various purposes. Microspheres occupied a central place in novel drug delivery, it
can targeted and localized drug delivery system. This Aceclofenac Microsphere is Prepared by using Spray drying
Technique in which release rate of drug is mainly depends on formulation composition (Eudragit RS 30 D and
Ethyl Cellulose (1:2 ratio)). Formulated microspheres were characterized for particle size, encapsulation efficiency
and In vitro studies. The optimum drug-to-polymer ratio and feed flow rate is responsible for higher percent yield,
smaller particle size and maximum encapsulation efficiency.
Design expert software assisted development and evaluation of cefpodoxime pro...Makrani Shaharukh
This document describes a study that developed and evaluated sustained release matrix tablets of the antibiotic drug Cefpodoxime Proxetil using natural polymers like karaya gum and acacia gum. 32 factorial designs were used to optimize the tablet formulations and evaluate the effect of polymer concentration on tablet properties like hardness and drug release. Tablets were prepared by direct compression and evaluated for drug-polymer compatibility, pre-compression parameters, post-compression parameters, in-vitro drug release, release kinetics, and stability. The optimized formulation F5 showed sustained drug release over 12 hours and maintained stability over time, indicating these matrix tablets could improve the oral bioavailability of Cefpodoxime Proxetil.
RP-HPLC method development and validation of ritonavir in bulk and pharmaceut...SriramNagarajan17
This document describes the development and validation of an RP-HPLC method for the quantification of the HIV protease inhibitor ritonavir (RIT) in bulk and pharmaceutical dosage forms. A simple isocratic RP-HPLC method was developed using a C18 column, mobile phase of 0.02M potassium dihydrogen phosphate buffer and acetonitrile (70:30 v/v), and detection at 237 nm. The method was validated per ICH guidelines and showed good linearity from 25-150 μg/mL, precision <0.5% RSD, accuracy of 99.3-100.6% recovery, and ability to quantify RIT in pharmaceutical tablets without interference from excipients.
Formulation and evaluation of folding film in a capsule for gastroretentive d...Bashant Kumar sah
This document describes research into developing a gastroretentive drug delivery system for losartan potassium using folding films enclosed in capsules. Sustained release films were prepared using polymers like HPMC and ethyl cellulose with polyethylene glycol as a plasticizer, through a solvent casting method. The films were evaluated for parameters like weight variation, thickness, folding endurance, tensile strength, drug content uniformity, surface pH and dissolution. A 2^3 factorial design was used to optimize the formulations, evaluating the effects of polymer amount, plasticizer amount, and coating solution concentration on drug release. The optimized formulations showed sustained drug release and remained stable over 30 days in accelerated stability studies.
DESIGN AND EVALUATION OF ORODISPERSIBLE TABLETS OF PANTOPRAZOLE SODIUMReshma Fathima .K
The document describes the design and evaluation of orodispersible tablets containing pantoprazole sodium using the sublimation method. Four formulations were developed using different concentrations of sublimation agent (camphor) and superdisintegrants. Formulation F4, containing the highest concentration of camphor and superdisintegrant, was found to have the fastest wetting time of 36 seconds and highest drug release of 87% over 9 minutes, making it the best performing formulation. The sublimation method allowed for the effective development of orodispersible tablets with high porosity, quick disintegration, and sufficient mechanical strength for pantoprazole sodium.
Formulation and evaluation of gelatin microspheres loaded with fenofibrateVimal Patel
The document summarizes a study that formulated and evaluated gelatin microspheres loaded with the drug fenofibrate using a coacervation and phase separation method. Two microsphere formulations were developed with different drug to polymer ratios and evaluated for properties such as particle size, encapsulation efficiency, in vitro drug release, and stability. The results showed the microspheres had particle sizes between 5-10μm and encapsulation efficiencies between 70-97%. In vitro drug release studies found one formulation released the drug over 12 hours in a sustained manner. The study concluded this formulation was suitable for oral sustained release of fenofibrate.
FORMULATION AND EVALUATION OF GELATIN MICROSPHERES LOADED WITH FENOFIBRATEReshma Fathima .K
The document summarizes the formulation and evaluation of gelatin microspheres loaded with the drug Fenofibrate. Two microsphere formulations were developed using a coacervation and phase separation method. Formulation F2 showed 97% drug encapsulation efficiency and released the drug over 12 hours, indicating it was suitable for oral sustained release. Evaluation tests on the microspheres showed they were spherical in shape, had good flow properties, and released the drug in a controlled manner without any burst release. The microspheres could facilitate the design of hard gelatin capsules for improved patient compliance.
This document describes optimization of nutrient components for tacrolimus production by Streptomyces tsukubaensis using statistical experimental designs. Plackett-Burman design identified dextrine white, cotton seed meal, and polyethylene glycol as significant factors affecting tacrolimus yield. Central composite design further optimized these components, determining optimal levels of 173.94 g/L dextrine white, 19.83 g/L cotton seed meal, and 24.72 g/L polyethylene glycol, achieving a maximum tacrolimus yield of 1.08 mg/g. Validation experiments confirmed the adequacy of the statistical model.
STUDY OF MPS UNDER STRESSED CONDITIONSvivatechijri
This study is done to access the chemical stability of the candidate compound in the pharmaceuticals.
Usually, it is performed at the preliminary stage in the process of drug development. Forced degradation/ stress
testing is performed under accelerated environment. The experimental conditions cause the candidate compound
to degrade under extreme conditions like acid and base hydrolysis, peroxide oxidation, photo-oxidation and
thermal stability to identify the resultant degradation products. This helps to establish degradation pathways and
thus intrinsic stability of a drug substance. The stability of product describes shelf life and storage conditions and
helps in the selection of appropriate formulations and their suitable packaging. This is compulsory for regulatory
documentation. The commonly used analytical approach for FDS is HPLC with UV and/ or MS but these
techniques consume a lot of time and not provide high resolution to confirm the precise detection of degradation
products. Use of UPLC with photodiode array and MS analysis supports the identification of degradation
products and also reduces the time needed to evolve stability indicating methods.
Abstract:
The Chronopharmacotherapy the drug administration is synchronised with circadian rhythms Formulation development of Microspheres is more reliable formulation as compare to single type dosage formulation due to it avoids dose dumping, as per required drug release profile is achieved For microspheres many polymers are used such as albumin, gelatine, starch, Eudragit, Polyacrylamide (“PAM”) these material loading capacity is high. Micro sponges which are Spherical are called as micro-balloons. Due to its hollow structure it shows good floating properties. In these systems use of Carbon-dioxide (CO2) as gas generating system which are used for floating purpose. The objective of present investigation is to prepared and evaluate a floating pulsatile drug delivery system of Aceclofenac. The strategy adopted for microspheres containing Aceclofenac as a material were prepared by emulsion solvent diffusion technique. Drug and polymer were mixed in dichloromethane and ethanol at 1:1 ratio. The drug and polymer solution were poured in water 50% W/V polyvinyl alcohol maintained at 30-40 C and the solution was stir at 500rpm using mechanical stirrer, The microspheres obtain were washed repeatedly with water until free from poly vinyl alcohol. The developed formulations were evaluated yield of floating microspheres particle size and shape, drug entrapment efficiency in-vitro evolution of floating ability, in-vitro drug release study. On the basis of these evolution parameters it was found that optimised floating pulsatile release formulation F7 showed higher drug entrapment efficiency floating time 6.8 minutes and the drug and polymer 32 1:3 ratio the particle size was increased.
Key Words: Chronopharmacotherapy, Floating pulsatile drug delivery, Aceclofenac.
This document discusses the formulation and evaluation of calcium alginate beads loaded with diclofenac sodium. The objective is to develop an extended release dosage form of diclofenac sodium to reduce dosing frequency and improve patient compliance by maintaining therapeutic drug levels. Calcium alginate beads are prepared using an ionotropic gelation method by dropping sodium alginate solution containing diclofenac sodium into calcium chloride solution, resulting in crosslinking and formation of beads. The beads are evaluated for drug release using dissolution studies.
Formulation and In-Vitro Evaluation of Fluconazole Loaded Microsponge Gel For...iosrjce
IOSR Journal of Pharmacy and Biological Sciences(IOSR-JPBS) is a double blind peer reviewed International Journal that provides rapid publication (within a month) of articles in all areas of Pharmacy and Biological Science. The journal welcomes publications of high quality papers on theoretical developments and practical applications in Pharmacy and Biological Science. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
Formulation and characterization of epigallocatechin gallate nanoparticlesRamkumar Ponnuraj
This document describes the formulation and characterization of Epigallocatechin gallate (EGCG) nanoparticles. EGCG was encapsulated in chitosan nanoparticles using ionic gelation with sodium tripolyphosphate to improve its bioavailability. Different ratios of EGCG to chitosan were tested, and a 1:0.5 ratio showed the highest drug loading and encapsulation efficiency. The resulting nanoparticles were spherical with a size range of 198-385 nm. In vitro drug release and characterization studies demonstrated the nanoparticles were a promising delivery system for EGCG with improved absorption.
Similar to Design of Pulsatile Tablets of Pantoprazole Sodium: Factorial Design Approach (20)
Capsules are solid dosage forms that enclose drugs within hard or soft soluble shells, usually made of gelatin. There are two main types - hard gelatin capsules and soft gelatin capsules. Hard gelatin capsules have a two-piece shell and are produced via a dipping process, while soft capsules have a one-piece shell and enclose liquids or semisolids. Capsules offer advantages like taste masking, but have disadvantages for hygroscopic or irritating drugs. They are manufactured using various filling machines from manual to automated and are filled mainly with powders, granules, pellets or tablets.
1. Preformulation studies characterize the physical and chemical properties of drug molecules to develop safe, effective, and stable dosage forms.
2. Key areas of preformulation include evaluating organoleptic properties, bulk characterization, solubility analysis, and stability analysis.
3. Important parameters studied are particle size, hygroscopicity, crystallinity, polymorphism, and powder flow properties which can impact drug dissolution, bioavailability, stability and manufacturability of dosage forms.
The document discusses the key aspects of a prescription, including:
- A prescription is a written order from a medical practitioner to a pharmacist to dispense a specific medication. It includes directions for use and administration.
- The main parts of a prescription include: date, patient information, drug names and quantities, directions for use, and prescriber information.
- When handling a prescription, pharmacists must carefully read, check ingredients, and label dispensed medications to avoid errors. Modern prescribing often involves proprietary drug names for ease of use, but official drug names are preferred. Abbreviations can introduce risks if not clearly understood.
This document discusses different dosage forms used to deliver drugs to the body. It defines dosage forms as the means of delivering active pharmaceutical ingredients (APIs) to sites of action within the body. Dosage forms contain APIs and excipients. They are classified based on route of administration and physical form. Solid dosage forms include tablets, capsules, and implants. Semi-solid forms include ointments, creams, and suppositories. Liquid forms include oral solutions, suspensions, and emulsions. The document provides examples and descriptions of various common dosage forms.
This document discusses different types of powders used in pharmacy. It describes bulk powders meant for external use which are supplied in containers designed for application. Common bulk powders include dusting powders, insufflations, snuffs, and dentifrices. Dusting powders are used on the skin and in body cavities, and contain ingredients like talc, starch, zinc oxide, and salicylic acid. Insufflations and snuffs are inhaled into body cavities and nostrils. Dentifrices contain abrasives like calcium carbonate and flavors to clean teeth. Simple and compound powders for internal use contain one or multiple ingredients wrapped in individual doses. Cachets enclose powders in shells
The document discusses factors that influence the dosage of drugs, noting that dosage cannot be fixed rigidly and must account for factors like age, health, weight, administration route, and drug interactions. It provides details on how factors like age, sex, weight, time of administration, disease states, and metabolic disturbances can impact a drug's effects and required dosage. The goal of considering these influencing factors is to determine the optimal dosage for each individual to achieve the desired therapeutic effects while avoiding toxicity.
This document discusses various pharmaceutical calculations related to dispensing medications. It covers:
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The document provides detailed examples and step-by-step workings for various calculation types pharmacists may encounter when dispensing prescriptions.
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The document discusses common defects that can occur during the tablet coating process and their potential causes and remedies. It describes defects such as blistering from overheating, chipping from high attrition, cratering from excessive coating solution, and pitting from excess core heating. Solutions include modifying drying conditions, adjusting coating formulations, and optimizing machine operating parameters. An understanding of tablet formulations and coating processes is necessary to identify and address coating defects.
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Parenteral products are unique dosage forms that are injected directly into the body, bypassing the gastrointestinal tract. They must be exceptionally pure and sterile to avoid contamination. Certain drugs can only be administered parenterally because they are degraded in the GI tract. Characteristics of parenteral products include being sterile, pyrogen-free, isotonic with body fluids, and stable both chemically and microbiologically throughout their shelf life. The preformulation properties of drugs and excipients used in parenterals, such as solubility, thermal profile, and particle size, must be evaluated to ensure quality, safety and efficacy.
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This document describes the design of a bilayer tablet containing atorvastatin and aspirin for the treatment of cardiovascular diseases. The bilayer tablet contains an immediate release layer of atorvastatin and an enteric-coated pulsatile release layer of aspirin. Four formulations of each layer were developed with different concentrations of excipients. The pulsatile aspirin layers were coated with Eudragit S100 to protect the drug from the acidic environment of the stomach. Evaluation of the bilayer tablets showed acceptable physicochemical properties and drug release profiles. Formulation F3 was found to be the best with one layer providing immediate release of atorvastatin to lower cholesterol and the other layer delivering aspirin at the
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The document describes an experiment to determine the partition coefficient and dissociation constant of ibuprofen. It provides background on how these properties influence drug absorption. The pH-partition hypothesis states that passive drug diffusion is governed by the drug's pKa, lipid solubility of the un-ionized form (partition coefficient), and gastrointestinal pH. The experiment involves measuring the extraction of ibuprofen into an organic phase at different buffer pH levels to calculate the apparent and true partition coefficients and dissociation constant. Plotting the results allows determining these pharmacokinetic parameters.
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The document describes the design and evaluation of a pulsatile drug delivery system containing pantoprazole sodium to mimic the circadian rhythm of peptic ulcer. Six formulations of core tablets were developed using different concentrations of superdisintegrants. Tablets were then coated with Eudragit S100 to achieve a lag time of 5 hours before drug release. Evaluation showed the core tablets had acceptable hardness, friability, weight variation and drug content. No chemical interactions between the drug and polymers were observed. When coated tablets were tested, dissolution was prevented for 5 hours followed by rapid and complete drug release, indicating the system could deliver the drug during morning hours to match peptic ulcer symptoms.
ISO/IEC 27001, ISO/IEC 42001, and GDPR: Best Practices for Implementation and...PECB
Denis is a dynamic and results-driven Chief Information Officer (CIO) with a distinguished career spanning information systems analysis and technical project management. With a proven track record of spearheading the design and delivery of cutting-edge Information Management solutions, he has consistently elevated business operations, streamlined reporting functions, and maximized process efficiency.
Certified as an ISO/IEC 27001: Information Security Management Systems (ISMS) Lead Implementer, Data Protection Officer, and Cyber Risks Analyst, Denis brings a heightened focus on data security, privacy, and cyber resilience to every endeavor.
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What sets Denis apart is his comprehensive understanding of Business and Systems Analysis technologies, honed through involvement in all phases of the Software Development Lifecycle (SDLC). From meticulous requirements gathering to precise analysis, innovative design, rigorous development, thorough testing, and successful implementation, he has consistently delivered exceptional results.
Throughout his career, he has taken on multifaceted roles, from leading technical project management teams to owning solutions that drive operational excellence. His conscientious and proactive approach is unwavering, whether he is working independently or collaboratively within a team. His ability to connect with colleagues on a personal level underscores his commitment to fostering a harmonious and productive workplace environment.
Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
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Discover the Simplified Electron and Muon Model: A New Wave-Based Approach to Understanding Particles delves into a groundbreaking theory that presents electrons and muons as rotating soliton waves within oscillating spacetime. Geared towards students, researchers, and science buffs, this book breaks down complex ideas into simple explanations. It covers topics such as electron waves, temporal dynamics, and the implications of this model on particle physics. With clear illustrations and easy-to-follow explanations, readers will gain a new outlook on the universe's fundamental nature.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
A review of the growth of the Israel Genealogy Research Association Database Collection for the last 12 months. Our collection is now passed the 3 million mark and still growing. See which archives have contributed the most. See the different types of records we have, and which years have had records added. You can also see what we have for the future.
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How to Build a Module in Odoo 17 Using the Scaffold MethodCeline George
Odoo provides an option for creating a module by using a single line command. By using this command the user can make a whole structure of a module. It is very easy for a beginner to make a module. There is no need to make each file manually. This slide will show how to create a module using the scaffold method.
How to Build a Module in Odoo 17 Using the Scaffold Method
Design of Pulsatile Tablets of Pantoprazole Sodium: Factorial Design Approach
1. Available online: http://scholarsmepub.com/sjmps/ 333
Saudi Journal of Medical and Pharmaceutical Sciences ISSN 2413-4929 (Print)
Scholars Middle East Publishers ISSN 2413-4910 (Online)
Dubai, United Arab Emirates
Website: http://scholarsmepub.com/
Design of Pulsatile Tablets of Pantoprazole Sodium: Factorial Design Approach
Reshma Fathima K, Sivakumar R*
Department of Pharmaceutics, Grace College of Pharmacy, Palakkad – 678 004, Kerala, India
Original Research Article
*Corresponding author
Sivakumar R
Article History
Received: 12.02.2018
Accepted: 20.02.2018
Published: 30.03.2018
DOI:
10.21276/sjmps.2018.4.3.5
Abstract: The objective of the present study was to develop and optimize an oral
pulsatile drug delivery system containing pantoprazole sodium to mimic the
circadian rhythm of the peptic ulcer by releasing the drug with a distinct
predetermined lag time. Six fast disintegration core tablets were prepared for
preliminary trials using direct compression method. The tablets were evaluated for
hardness, friability assay and dissolution study. The best formulation were selected
for optimization to study the influence of Micro crystalline cellulose (MCC) and
Sodium starch glycolate (SSG) using 32
full factorial design. The optimized
formulations were selected for coating for pulsatile delivery. The results of the
study indicate f3 formulation was suitable for scale up.
Keywords: Pantoprazole Sodium, Factorial Design.
INTRODUCTION
Pantoprazole sodium is an anti-ulcer drug belonging to the class of proton
pump inhibitor. The is effective in the treatment of duodenal or gastric ulcer,
gastro oesophageal reflux disease and in the treatment Pulsatile systems constitute
a relatively new class of device the important of which is especially connected
with the recent advances in chronopharmacology [1]. In the last decade numerous
studies in animal as well as clinical studies have provided convincing evidence,
that the pharmacokinetics and / or the drug’s effects – side effects can be modified
by the circadian time and or/ the timing of drug application with in 24 h of the day
[2-3].
The pulsatile delivery system improve the
patient compliance when the drug is release at early
morning. The designed core tablets coated by using pH
sensitive methocrylic acid copolymers (Eudragit L00
and S100) as coat and pantoprazole as core material.
The use of pH dependent and time dependent polymers
as coating materials have been reported previously [4-6]
the enteric coating prevents disintegration of core in the
gastric fluid. On reaching the Illium (pH 7.2) the tablets
losses its enteric coating and drug release occur. The lag
phase created to achieve the pulsatile delivery Thus
formulation taken at night, will be effective on morning.
Factorial design and response surface
methodology is an important statistical tool to study the
effect of several factors influencing response by varying
them simultaneously by carryout limited number of
experiments. Literature survey revealed no study
carried out to formulate a pulsatile delivery system to
demonstrate the influence of formulation variables
using factorial design approach.
The objectives of the present investigation
was to carry out a systematic statistical study on
preparation of pulsatile delivery formulation using
factorial design approach and explore the application
for the formulation development.
MATERIALS AND METHODS
Pantoprazole sodium, Sodium starch glycolate,
Aerosil, Eudragit S100 (Yarrow chem products,
Mumbai), Magnesium stearate (lobe chemie Pvt Ltd,
Mumbai).Polyethylene glycol (Sd fine chem Ltd.
Mumbai.) All the materials and reagents were of
analytical grade.
Methods
Preparation of core tablets
The direct compression technique was used for
the preparation tablets. All the raw materials were
weighed and passed through #40 mesh sieves and
mixed well as per the formula given in Table 1 to meet
the tablet weight to 245mg. The powder blend was
lubricated using Magnesium stearate and aerosil at 1%
concentration of tablet weight. The powder blend was
compressed using an 8mm convex punch machine
(Rimek Mini press-1).
Evaluation of Core Tablets
Hardness and Friability
The crushing strength of the tablets was
measured using Monsanto hardness tester. The limit for
crushing strength of the tablets was kept in the range of
3-4 kg/cm2
. The friability of the tablets was measured
2. Reshma Fathima K & Sivakumar R., Saudi J. Med. Pharm. Sci., Vol-4, Iss-3 (Mar, 2018): 333-339
Available online: http://scholarsmepub.com/sjmps/ 334
using a Roche friabilator (Electrolab, India). Twenty
tablets were weighed and rotated for 4 min at 25 rpm.
The tablets were then reweighed and the percentage
friability was calculated.
Disintegration study for Core Tablets
Disintegration procedures for the Pantoprazole
sodium Pulsatile core tablets using 900 ml of 6.8 pH
phosphate buffer at 37°C. Six tablets were dropped into
individual tubes of the basket-rack assembly. Disks
were not mounted on the tubes and the time at which all
six tablets had disintegrated was recorded.
Dissolution study for Core Tablets
The dissolution studies for the pantoprazole
sodium core tablets were carried out using dissolution
test apparatus USP II paddle type. The dissolution
medium consisted of 900 ml of phosphate buffer of pH
6.8 for 60 min. The temperature of the medium was
maintained at 37±0.5°C. The speed of rotation of the
paddle was kept at 50 rpm. Aliquots of 5ml were
withdrawn after every 15 minutes. These samples were
diluted to make up the volume of 50ml with pH 6.8
buffer. The samples so withdrawn were replaced with
the fresh dissolution medium equilibrated at the same
temperature. The drug released at the different time
intervals from the dosage form is measured by UV
visible spectrophotometer, by measuring the absorbance
for the sample solutions at 289nm [7 -9]
Effect of Variables
To study the effects of variables on core tablets
performance and characteristics, different batches were
prepared using 32
factorial design. Amount of
microcrystalline cellulose and SSG were selected as
two independent variables. Hardness, friability,
disintegration and dissolution were selected as
dependent variables. Values of all variables and batch
codes are as shown in Table 2.
Optimization of Core Tablets
The factorial design is a technique that allows
identification of factors involved in a process and
assesses their relative importance. In addition, any
interaction between factors chosen can be identified.
Construction of a factorial design involves the selection
of parameters and choice of responses. Optimization
has been done by using 32
full factorial designs, where
the amount of MCC (X1) and the amount of SSG (X2)
were taken as independent variables.
Formulation of pulsatile tablets
The coating solution was developed by
dissolving Eudragit S 100 (20%) in acetone and
isopropyl alcohol mix solvents and then Polyethylene
glycol (2%), Titanium dioxide (5%) was added and
stirring. The resulting solution was adjusted with
acetone and isopropyl alcohol mixed solvents. The core
tablets were coated using dipping and drying method
and increase in weight percent after coating was
determined as the coating level.
Evaluation of pulsatile tablets
The thickness of the Eudragit S coating was
measured using screw gauge and was expressed in mm.
The core tablets were selected randomly and weighed
individually for weight variation. The test requirement
is meeting if none of the individual weights are less
than 90 % or more than the 110% of the average.
Disintegration test for coated tablet
The disintegration time of the coated tablets
was determined using the USP model disintegration
apparatus. Six tablets were placed in the basket rack
assembly, and were run for 2 hours in 0.1 N HCl media
with the discs. The tablets were removed from the
solution, gently dried by bloating. The test was then
continued by placing the tablets in phosphate buffer pH
6.8, for 3 h, maintaining the temperature at 37±2°C
Dissolution study for coated tablet
The dissolution studies of the pulsatile tablets
containing pantoprazole sodium was carried out using
900 ml of 0.1N HCl for 2h followed by pH 6.8
phosphate buffer solutions. The set condition was
37±0.5°C, 50 rpm, and paddle type USP XX111
apparatus. Aliquots withdrawn for every one hour
intervals and were replenished immediately with the
same volume of fresh buffer medium. Aliquots,
following suitable diluents were assessed
spectrophotometrically at 289nm.
Statistical analysis of data
Response of different batches obtained using
factorial design is shown in Table 2. The Obtained data
were subjected to multiple regression analysis using
design software (USA) data were fitted in second order
polynomial equation.
Y= b0 +b 1X1 + b2 X2 + b11 X1X2 + b22X2X2 + b12 X1X2
Where y is the dependent variables, b0 is the
arithmetic mean response of the nine runs, and b1 is the
estimated coefficient for the factors X1. The main
effects (X1 and X2) represent the average result of
changing one factor at a time from its low to high value.
On the basis of the preliminary trial a 32
full factorial
design was employed to study the effects of
independent variables on dependent variables. Response
surface plots were generated using mini tab software.
Results of the multiple regression analysis are all
parameters study is summarized in table 3.
Coating for optimized formulation
On the basis of factorial design approach core
tablet batch (f3) was selected for further development
of pulsatile tablets. The coating solution was prepared
using Eudragit S. Dissolving Eudragit S (20%) in
acetone and isopropyl alcohol mix solvents and then
3. Reshma Fathima K & Sivakumar R., Saudi J. Med. Pharm. Sci., Vol-4, Iss-3 (Mar, 2018): 333-339
Available online: http://scholarsmepub.com/sjmps/ 335
Polyethylene glycol (2%), Titanium dioxide (5%) was
added and stirring. The resulting solution was adjusted
with acetone and isopropyl alcohol mixed solvents.
The core tablets were coated using dipping and drying
method and increase in weight percent after coating
was determined as the coating level. Prepared pulsatile
tablets were characterized for following parameter.
In vitro release study for optimized pulsatile tablets
The dissolution studies of the optimized
pulsatile tablets containing pantoprazole sodium was
carried out using 900 ml of 0.1N HCl for 2h followed
by pH 6.8 phosphate buffer solutions. The set condition
was 37±0.5°C, 50 rpm, and paddle type USP XX111
apparatus. Aliquots withdrawn for every one hour
intervals and were replenished immediately with the
same volume of fresh buffer medium. Aliquots,
following suitable diluents were assessed
spectrophotometrically at 289nm.
RESULTS AND DISCUSSION
Amount of MCC and SSG were found to be critical in
preparation hence selected variables in the 32
factorial
designs.
Table-1: Composition of core tablets of Pantoprazole Sodium for Preliminary trial
Ingredients (mg) D1 D2 D3 D4 D5 D6
Pantoprazole 40 40 40 40 40 40
MCC 200 200 200 200 200 200
Cross Carmellose - - - 1 1.5 2
SSG 1 1.5 2 - - -
Magnesium stearate 2 2 2 2 2 2
Aerosil 2 1.5 1 2 1.5 1
Total weight 245 245 245 245 245 245
Table-2: Lay out of 32
full factorial designs
Independent variables Dependent variables
Code X1 X2 Y1 (Kg Cm2
) Y2 (%) Y3(S) Y4(%)
f1 -1 - 1 3.8 0.78 115 83.7
f2 -1 0 4.0 0.79 116 85.5
f3 -1 +1 4.2 0.65 117 95.8
f4 0 -1 4.4 0.62 118 85.5
f6 0 +1 4.6 0.64 120 86.8
f7 +1 -1 4.8 0.57 121 89.1
f8 +1 0 5.0 0.56 123 81.2
f9 +1 +1 5..5 0.53 127 85.5
Note: all the values are average of three such determinations
Table-3: Summary of regression analysis and results of measured responses
Parameters Coefficients
β0 β1 β2 β11 β22 β12 r2
p
Y1 4.122 0.50 0.10 0.166 0.166 0.001
Y2 0.656 -0.93 -0.02 -0.010 -0.030 0.016
Y3 124.0 2.66 -1.00 -1.000 -0.000 0.416
Y4 86.00 -2.55 3.33 -1.35 1.70 0.031
4. Reshma Fathima K & Sivakumar R., Saudi J. Med. Pharm. Sci., Vol-4, Iss-3 (Mar, 2018): 333-339
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1
4.0
0
4.4
4.8
-1
5.2
0 -1
1
H a r dne ss ( k g/ cm 2 )
X 2
X 1
S urfa ce P lot of H a rdne s s (k g/ cm 2 ) v s X 2 , X 1
Fig-1: Surface Plot for Hardness
X 1
X2
1.00.50.0-0.5-1.0
1.0
0.5
0.0
-0.5
-1.0
>
–
–
–
–
< 4.00
4.00 4.25
4.25 4.50
4.50 4.75
4.75 5.00
5.00
(k g /c m 2)
H ard n ess
C ontour P lot of H a r dne s s (k g/ c m 2 ) v s X 2 , X 1
Fig-2: Contour Plot for Hardness
1
0
0.6
0.7
-1
0.8
0 -1
1
F r ia bility ( % )
X 2
X 1
S ur fa c e P lo t o f F r ia bility (% ) v s X 2 , X 1
Fig-3: Surface Plot for Friability
5. Reshma Fathima K & Sivakumar R., Saudi J. Med. Pharm. Sci., Vol-4, Iss-3 (Mar, 2018): 333-339
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X 1
X2
1.00.50.0-0.5-1.0
1.0
0.5
0.0
-0.5
-1.0
>
–
–
–
–
< 0.55
0.55 0.60
0.60 0.65
0.65 0.70
0.70 0.75
0.75
F riab ility (% )
C ontour P lo t o f F r ia bility (% ) v s X 2 , X 1
Fig-4: Contour plot for Friability
1
120
0
122
124
-1
126
0 -1
1
Disinte gr a tio n tim e ( se c)
X 2
X 1
S ur fa c e P lo t o f D is inte gr a tio n tim e (s e c ) v s X 2 , X 1
Fig-5: Surface plot for disintegration time
X 1
X2
1.00.50.0-0.5-1.0
1.0
0.5
0.0
-0.5
-1.0
>
–
–
–
–
< 120.0
120.0 121.5
121.5 123.0
123.0 124.5
124.5 126.0
126.0
tim e (sec )
D isin teg ratio n
C ontour P lot of D is inte gra tion tim e (s e c) v s X 2 , X 1
Fig-6: Contour plot for disintegration Time
6. Reshma Fathima K & Sivakumar R., Saudi J. Med. Pharm. Sci., Vol-4, Iss-3 (Mar, 2018): 333-339
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1
80 0
85
90
-1
95
0 -1
1
n-v itr o r e le a se study ( % )
X 2
X 1
S urfa ce P lot of In-v itro re le a se study (% ) v s X 2 , X 1
Fig-7: Surface Plot for in vitro Release Study
X 1
X2
1 .00.50.0-0.5-1.0
1.0
0.5
0.0
-0.5
-1.0
>
–
–
–
–
–
–
< 82
82 84
84 86
86 88
88 90
90 92
92 94
94
(% )
stu d y
release
In -v itr o
C o nto ur P lo t o f In-v itr o r e le a s e s tudy (% ) v s X 2 , X 1
Fig-8: Contour Plot for in vitro Release Study
Statistical analysis of data
Response of different batches obtained using
factorial design is shown in Table 3. Obtained data were
subjected to multiple regression analysis using design
software (USA) data were fitted in second order
polynomial equation.
Y= b0 +b 1X1 + b2 X2 + b11 X1X2 + b22 X2X2 + b12
X1X2
Where y is the dependent variables, b0 is the
arithmetic mean response of the nine runs, and b1 is the
estimated coefficient for the factors X1. The main
effects (X1 and X2) represent the average result of
changing one factor at a time from its low to high value.
On the basis of the preliminary trial a 32
full factorial
design was employed to study the effects of
independent variables on dependent variables. Response
surface plots were generated using mini tab software.
Results of the multiple regression analysis are all
parameters study is summarized in Table 3 and Fig 1-8.
Effect on hardness
To study the effect of MCC and SSG on
hardness of the tablets Eq.(1) was generated after fitting
the observed coefficient in Eq . (2).
Y= b0 +b 1X1 + b2 X2 + b11 X1X2 + b22 X2X2 + b12
X1X2
Y1 = 4.122+ 0.50 X1 +0.10 X2 +0.166 X1X1 +
0.166X2X2 - 0.00X1X2
The values for hardness of the tablets Y1
ranges between 3.8-5.1Kg/cm2
and were significantly
influenced (P = <0.05) by one study factor (X1).
Hardness was found to an inverse function of
X1 and X2. Hardness of the tablets slightly increased
with increasing amount of MCC and SSG. Both MCC
and SSG showed inhibitory effect of on hardness. MCC
alone were more predominant than SSG on hardness of
the tablet. It has indicated by the observed respective
coefficient. (Table 3)
Effect on friability
To understand the effect of concentration of
MCC and SSG on friability of tablets was fitted in Eqs
(1) to generate Eq. (3) respectively.
Y2 = 0.656 – 0.93X1 – 0.023X2 + 0.010X1X1 – 0.030
X2X2 – 0.02X1 X2
7. Reshma Fathima K & Sivakumar R., Saudi J. Med. Pharm. Sci., Vol-4, Iss-3 (Mar, 2018): 333-339
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The value for friability of tablets Y2 ranges
between 0.53- 0.78% indicated all the formulation were
successfully passed the friability test. Optimum
concentration of MCC significantly influences the
friability values. i.e increased value of friability. But
SSG and combination of SSG and MCC favorable for
the reduction of friability.
Effect of disintegration and dissolution
The drug dissolution and disintegration are
important variables for bioavailability of drug. These
parameters are dependent on the process of preparation,
physiochemical properties of drug and formulation
variables. The drug disintegration varied from 117 to
127 sec. The value for disintegration time of tablets
ranges between 117-127 sec. The response was
insignificant by the one study factor. Combination of
SSG and MCC significantly influence the disintegration
time.
Y3 = 124.00 + 2.667 X1 – 1.00 X2– 1.00X1X1– 0.00
X2X2 + 0.500 X1X2
Dissolution studies for core tablets
In vitro release studies were carried out using
USP XX111 dissolution assembly. The release profile
obtained for all the formulations were shown in Fig 2. It
was observed that the drug release from the
formulations increase amount of MCC and SSG. 80 –
90 % of incorporated drug within 30 min after lag time
of 5 h. The negative results of MCC and SSG indicate
both the excipients insignificant value so that the values
are not considered for the study.
Y4 = 86.0 – 2.55 X1 + 3.33 X2 – 1.35 X1X1 + 1.70 X2X2
– 1.95 X1X2
Evaluation of pulsatile tablets
On the basis of hardness, friability,
disintegration and dissolution f5 was selected as better
formulation for designing pulsatile tablets. The release
of the drug from the tablets is strongly affected by the
PH of the medium. During the dissolution study the
cumulative percentage of pantoprazole from the tablets
was plotted as a function of time.
CONCLUSION
As indicated in introduction, the main aim of
the work described here was to design new pulsatile
delivery tablets of pantoprazole using factorial design
approach for better treatment out come for peptic ulcer.
The present study demonstrates that the pantoprazole
pulsatile tablets could be successfully designed for
chronopharmcological effects to reduce the symptoms
of peptic ulcer at early morning. Preparation of Pulsatile
tablets using factorial design was found to be well
suited and sound approach to obtain the successful
formulations. Inclusion of MCC and sodium starch
glycolate greatly influence the quality of formulation.
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