This document describes the formulation and evaluation of a gastroretentive floating dosage form of lamivudine. Specifically, it aims to design a hydrodynamically balanced non-effervescent floating drug delivery system of lamivudine that prolongs drug release while extending its residence time in the body. Such a system could provide consistent plasma drug levels over prolonged periods compared to conventional dosage forms. The document discusses controlled release systems, gastroretentive drug delivery systems including floating systems, melt granulation as a processing technique, and provides information on lamivudine and hydroxypropyl methylcellulose as the drug and polymer used in the study.
This document describes the formulation and evaluation of a gastroretentive floating dosage form of lamivudine. Key points include:
- Lamivudine was chosen as a candidate for a gastroretentive dosage form due to its low biological half-life and instability in the small intestine.
- Hydroxypropyl methylcellulose (HPMC) was selected as the polymer for the floating formulation. Dose calculations were performed to determine the theoretical drug load needed to provide sustained release over 12 hours.
- Materials and methods for developing melt granulation floating tablets containing lamivudine and HPMC are described, including equipment used and process parameters. Evaluation of the tablets would assess their floating properties and
This document describes the formulation and evaluation of an osmotic drug delivery system for propranolol hydrochloride. Six formulations of an osmotic tablet were developed using different osmogens. The tablets were evaluated for physical properties and in vitro drug release. Formulations using mannitol as the osmogen showed controlled release for 12 hours, making it the optimized formulation. Osmotic drug delivery systems offer advantages like controlled release over an extended period, but require evaluation of factors like osmogen concentration to achieve the desired release profile.
This document describes the formulation and evaluation of an osmotic drug delivery system for propranolol hydrochloride. Six formulations of an osmotic tablet core were developed using different osmogens (sodium acetate, potassium chloride, mannitol) at varying concentrations. The cores were then coated with cellulose acetate to form semi-permeable membranes. Formulation F6, which used 120 mg of mannitol as the osmogen, provided controlled release of the drug for 12 hours and was considered optimized. The coated tablets were evaluated for properties like drug release kinetics, stability, orifice size and more to characterize the osmotic system.
The main objective of present investigation is to formulate the floating tablets of
Ranitidine.HCl using 32 factorial design. Ranitidine.HCl, H2-receptor antagonist belongs to
BCS Class-III. The Floating tablets of Ranitidine.HCl were prepared employing different
concentrations of HPMCK4M and Guar Gum in different combinations as a release rate
modifiers by Direct Compression technique using 32 factorial design. The concentration of
Polymers , HPMCK4M and Guar Gum required to achieve desired drug release was selected
as independent variables, X1 and X2 respectively whereas, time required for 10% of drug
dissolution (t10%), 50% (t50%), 75% (t75%) and 90% (t90%) were selected as dependent variables.
Totally nine formulations were designed and are evaluated for hardness, friability, thickness,
% drug content, Floating Lag time, In-vitro drug release. From the Results concluded that all
the formulation were found to be within the Pharmacopoeial limits and the In-vitro
dissolution profiles of all formulations were fitted in to different Kinetic models, the
statistical parameters like intercept (a), slope (b) & regression coefficient (r) were calculated.
Polynomial equations were developed for t10%, t50%, t75%, t90%. Validity of developed
polynomial equations were verified by designing 2 check point formulations(C1, C2).
According to SUPAC guidelines the formulation (F5) containing combination of 22.5%
HPMCK4M and 22.5% Guar Gum, is the most similar formulation (similarity factor f2=85.01,
dissimilarity factor f1= 15.358 & No significant difference, t= 0.169) to marketed product
(ZANTAC). The selected formulation (F5) follows Higuchi’s kinetics, and the mechanism of
drug release was found to be Non-Fickian Diffusion (n= 0.922).
FORMULATION AND IN-VITRO EVALUATION OF PULSATILE DRUG DELIVERY SYSTEM OF...Aditya Ceepathi
The document discusses the formulation and in-vitro evaluation of a pulsatile drug delivery system for dofetilide. It begins with an introduction to oral controlled drug delivery systems including continuous release and pulsatile release systems. It then discusses gastroretentive drug delivery approaches including floating drug delivery systems. The aims and objectives of formulating a dofetilide pulsatile system using HPMC polymers is described. Various studies to be conducted including evaluating the effect of polymer type and concentration on drug release are also mentioned. In summary, the document outlines the background and methodology for developing a pulsatile floating tablet of dofetilide to achieve pulsatile release in the stomach.
Formulation and Evaluation of Floating Matrix Tablets of an Antipsychotic DrugBRNSSPublicationHubI
This document describes the formulation and evaluation of floating matrix tablets containing ziprasidone, an antipsychotic drug, for gastroretentive drug delivery. Ziprasidone was selected as a model drug and formulated into multi-unit floating tablets using various fatty and hydrophilic polymers like Gelucire 43/01, HPMC K4M, and HPMC K100M via wet and melt granulation techniques. The formulated tablets were evaluated for drug content, physical properties, in vitro buoyancy, and floating lag time. The results showed that tablets containing Gelucire 43/01 as the polymer had optimal floating properties and drug release characteristics, making it a suitable candidate for the controlled delivery of ziprasidone in
Background: The main objective of present research work is to formulate the Carbamazepine Fast Dissoving tablets. Carbamazepine, an
antiepileptic, belongs to BCS Class-II and used to control some types of seizures in the treatment of epilepsy and Neuropathic Pain by
blocking use-dependent sodium channels. Methods: The Fast Dissoving tablets of Carbamazepine were prepared employing different
concentrations of Crospovidone and Croscarmellose sodium in different combinations as a Sperdisintegrants by Direct Compression technique
using 32
factorial design. The concentration of Crospovidone and Croscarmellose sodium was selected as independent variables, X1
and X2 respectively whereas, wetting time, Disintegration time, t
50% ,t90%were selected as dependent variables. Results and Discussion:
Totally nine formulations were designed and are evaluated for hardness, friability, thickness, Assay, Wetting time, Disintegration time, Invitro
drug release. From the Results concluded that all the formulation were found to be with in the Pharmacopoeial limits and the In-vitro
dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept (a), slope (b) &
regression coefficient (r) were calculated. Polynomial equations were developed for Wetting time, Disintegration time, t50%, t90%. Validity of
developed polynomial equations were verified by designing 2 check point formulations (C1
, C2
). According to SUPAC guidelines the
formulation (F5
) containing combination of 9.375% Crospovidone and 9.375% Croscarmellose, is the most similar formulation (similarity factor
f
2
=82.675, dissimilarity factor f1
= 2.049 & No significant difference, t= 0.041) to marketed product (TEGRETOL-100). Conclusion: The
selected formulation (F5
) follows First order, Higuchi’s kinetics, mechanism of drug release was found to be Non-Fickian Diffusion (n= 0.665).
KEYWORDS: Carbamazepine, 3
2Factorial Design, Crospovidone , croscarmellose Sodium, Wetting Time, Disintegration Time.
This document describes the formulation and evaluation of a gastroretentive floating dosage form of lamivudine. Key points include:
- Lamivudine was chosen as a candidate for a gastroretentive dosage form due to its low biological half-life and instability in the small intestine.
- Hydroxypropyl methylcellulose (HPMC) was selected as the polymer for the floating formulation. Dose calculations were performed to determine the theoretical drug load needed to provide sustained release over 12 hours.
- Materials and methods for developing melt granulation floating tablets containing lamivudine and HPMC are described, including equipment used and process parameters. Evaluation of the tablets would assess their floating properties and
This document describes the formulation and evaluation of an osmotic drug delivery system for propranolol hydrochloride. Six formulations of an osmotic tablet were developed using different osmogens. The tablets were evaluated for physical properties and in vitro drug release. Formulations using mannitol as the osmogen showed controlled release for 12 hours, making it the optimized formulation. Osmotic drug delivery systems offer advantages like controlled release over an extended period, but require evaluation of factors like osmogen concentration to achieve the desired release profile.
This document describes the formulation and evaluation of an osmotic drug delivery system for propranolol hydrochloride. Six formulations of an osmotic tablet core were developed using different osmogens (sodium acetate, potassium chloride, mannitol) at varying concentrations. The cores were then coated with cellulose acetate to form semi-permeable membranes. Formulation F6, which used 120 mg of mannitol as the osmogen, provided controlled release of the drug for 12 hours and was considered optimized. The coated tablets were evaluated for properties like drug release kinetics, stability, orifice size and more to characterize the osmotic system.
The main objective of present investigation is to formulate the floating tablets of
Ranitidine.HCl using 32 factorial design. Ranitidine.HCl, H2-receptor antagonist belongs to
BCS Class-III. The Floating tablets of Ranitidine.HCl were prepared employing different
concentrations of HPMCK4M and Guar Gum in different combinations as a release rate
modifiers by Direct Compression technique using 32 factorial design. The concentration of
Polymers , HPMCK4M and Guar Gum required to achieve desired drug release was selected
as independent variables, X1 and X2 respectively whereas, time required for 10% of drug
dissolution (t10%), 50% (t50%), 75% (t75%) and 90% (t90%) were selected as dependent variables.
Totally nine formulations were designed and are evaluated for hardness, friability, thickness,
% drug content, Floating Lag time, In-vitro drug release. From the Results concluded that all
the formulation were found to be within the Pharmacopoeial limits and the In-vitro
dissolution profiles of all formulations were fitted in to different Kinetic models, the
statistical parameters like intercept (a), slope (b) & regression coefficient (r) were calculated.
Polynomial equations were developed for t10%, t50%, t75%, t90%. Validity of developed
polynomial equations were verified by designing 2 check point formulations(C1, C2).
According to SUPAC guidelines the formulation (F5) containing combination of 22.5%
HPMCK4M and 22.5% Guar Gum, is the most similar formulation (similarity factor f2=85.01,
dissimilarity factor f1= 15.358 & No significant difference, t= 0.169) to marketed product
(ZANTAC). The selected formulation (F5) follows Higuchi’s kinetics, and the mechanism of
drug release was found to be Non-Fickian Diffusion (n= 0.922).
FORMULATION AND IN-VITRO EVALUATION OF PULSATILE DRUG DELIVERY SYSTEM OF...Aditya Ceepathi
The document discusses the formulation and in-vitro evaluation of a pulsatile drug delivery system for dofetilide. It begins with an introduction to oral controlled drug delivery systems including continuous release and pulsatile release systems. It then discusses gastroretentive drug delivery approaches including floating drug delivery systems. The aims and objectives of formulating a dofetilide pulsatile system using HPMC polymers is described. Various studies to be conducted including evaluating the effect of polymer type and concentration on drug release are also mentioned. In summary, the document outlines the background and methodology for developing a pulsatile floating tablet of dofetilide to achieve pulsatile release in the stomach.
Formulation and Evaluation of Floating Matrix Tablets of an Antipsychotic DrugBRNSSPublicationHubI
This document describes the formulation and evaluation of floating matrix tablets containing ziprasidone, an antipsychotic drug, for gastroretentive drug delivery. Ziprasidone was selected as a model drug and formulated into multi-unit floating tablets using various fatty and hydrophilic polymers like Gelucire 43/01, HPMC K4M, and HPMC K100M via wet and melt granulation techniques. The formulated tablets were evaluated for drug content, physical properties, in vitro buoyancy, and floating lag time. The results showed that tablets containing Gelucire 43/01 as the polymer had optimal floating properties and drug release characteristics, making it a suitable candidate for the controlled delivery of ziprasidone in
Background: The main objective of present research work is to formulate the Carbamazepine Fast Dissoving tablets. Carbamazepine, an
antiepileptic, belongs to BCS Class-II and used to control some types of seizures in the treatment of epilepsy and Neuropathic Pain by
blocking use-dependent sodium channels. Methods: The Fast Dissoving tablets of Carbamazepine were prepared employing different
concentrations of Crospovidone and Croscarmellose sodium in different combinations as a Sperdisintegrants by Direct Compression technique
using 32
factorial design. The concentration of Crospovidone and Croscarmellose sodium was selected as independent variables, X1
and X2 respectively whereas, wetting time, Disintegration time, t
50% ,t90%were selected as dependent variables. Results and Discussion:
Totally nine formulations were designed and are evaluated for hardness, friability, thickness, Assay, Wetting time, Disintegration time, Invitro
drug release. From the Results concluded that all the formulation were found to be with in the Pharmacopoeial limits and the In-vitro
dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept (a), slope (b) &
regression coefficient (r) were calculated. Polynomial equations were developed for Wetting time, Disintegration time, t50%, t90%. Validity of
developed polynomial equations were verified by designing 2 check point formulations (C1
, C2
). According to SUPAC guidelines the
formulation (F5
) containing combination of 9.375% Crospovidone and 9.375% Croscarmellose, is the most similar formulation (similarity factor
f
2
=82.675, dissimilarity factor f1
= 2.049 & No significant difference, t= 0.041) to marketed product (TEGRETOL-100). Conclusion: The
selected formulation (F5
) follows First order, Higuchi’s kinetics, mechanism of drug release was found to be Non-Fickian Diffusion (n= 0.665).
KEYWORDS: Carbamazepine, 3
2Factorial Design, Crospovidone , croscarmellose Sodium, Wetting Time, Disintegration Time.
The document discusses the formulation and evaluation of an artemether sustained release floating bilayer tablet. It aims to develop a floating drug delivery system for artemether to increase its gastric residence time and provide sustained release to ensure optimal drug levels in the blood and minimize side effects. The document provides background on floating drug delivery systems and reviews previous literature on developing such systems for other drugs. It then gives information on the drug artemether and outlines the objectives and methodology that will be used in the study.
ABSTRACT
The main objective of present research work is to formulate the of Domperidone Maleate floating tablets.
Domperidone Maleate, an antiemetic and a prokinetic agent belongs to BCS Class-II and Indicated for treatment of
upper gastrointestinal motility disorders by blocking the action of Dopamine. The Floating tablets of Domperidone
Maleate were prepared employing different concentrations of HPMCK4M and Guar Gum in different combinations
as a release rate modifiers by Direct Compression technique using 32 factorial design. The concentration of
HPMCK4M and Guar Gum was selected as independent variables, X1 and X2 respectively whereas, time required
for drug dissolution t10%, t50%,t75%,t90%were selected as dependent variables. Totally nine formulations were designed
and are evaluated for hardness, friability, thickness, Assay, Floating Lag time, In-vitro drug release. From the
Results concluded that all the formulation were found to be with in the Pharmacopoeial limits and the In-vitro
dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like
intercept (a), slope (b) & regression coefficient (r) were calculated. Polynomial equations were developed for t10%,
t50%, t75%, t90%. Validity of developed polynomial equations were verified by designing 2 check point formulations(C1,
C2). According to SUPAC guidelines the formulation (F5) containing combination of 18.75% HPMCK4M and
18.75% Guar Gum, is the most similar formulation (similarity factor f2=89.03, dissimilarity factor f1= 11.539& No
significant difference, t= 0.169) to marketed product (DOMSTAL OD). The selected formulation (F5) follows
Higuchi’s kinetics, and the mechanism of drug release was found to be Non-Fickian Diffusion (n= 0.925).
Keywords: Domperidone Maleate, 32Factorial Design, Gastro retentive Floating Tablet, HPMCK100M, Sodium
bicarbonate, Floating Lag Time, SUPAC, Non-Fickian Diffusion Mechanism.
Formulation of Timolol Maleate Sustained-release Matrix TabletsBRNSSPublicationHubI
This document describes the formulation of sustained-release matrix tablets of timolol maleate using different grades of hydroxypropyl methylcellulose (HPMC) polymers. Timolol maleate matrix tablets were prepared by wet granulation method using HPMC K100M and HPMC K15M polymers. Tablet formulations containing a combination of HPMC K100M and HPMC K15M (batches F26 to F30) provided drug release for over 10 hours. No significant change in drug release was observed with changing the polymer ratio. All batches showed some initial burst release as well. The release mechanism was determined to be anomalous diffusion or diffusion coupled with erosion.
Formulation and Evaluation of Stavudine Controlled Release Matrix TabletSunil Vadithya
The document presents a study on the formulation and evaluation of controlled release matrix tablets of Stavudine. Stavudine was selected as a model drug due to its short half-life. Hydroxypropyl methylcellulose (HPMC) and Carbopol 934 were used as release retarding polymers to develop sustained release matrix tablets. Tablets were prepared by direct compression method and evaluated for physical parameters, drug content, swelling index and in-vitro drug release up to 8 hours. The results showed that formulations containing higher proportions of polymers released the drug in a controlled manner for an extended period of time.
A Review- Pharmaceutical and Pharmacokinetic Aspect of Nanocrystalline Suspen...Dhaval shah
This document reviews pharmaceutical and pharmacokinetic aspects of nanocrystalline suspensions. It discusses how nanocrystals have emerged as a potential formulation strategy to enhance dissolution rate and solubility for poorly soluble drugs. The review provides an in-depth look at processing methods, quantitative assessments of solubility and dissolution rates, and their correlation to pharmacokinetic data. It also discusses the lack of understanding around changes in thermodynamic and kinetic properties like solubility and dissolution rate upon nanosizing, and reviews literature on quantitatively studying the effect of particle size and surface area on initial dissolution rate enhancement.
A Review- Pharmaceutical and Pharmacokinetic Aspect of Nanocrystalline Suspen...Dhaval shah
This document reviews pharmaceutical and pharmacokinetic aspects of nanocrystalline suspensions. It discusses how nanocrystals have emerged as a potential formulation strategy to enhance dissolution rate and solubility for poorly soluble drugs. The review provides an in-depth look at processing methods, quantitative assessments of solubility and dissolution rates, and their correlation to pharmacokinetic data. It also discusses the lack of understanding around changes in thermodynamic and kinetic properties like solubility and dissolution rate upon nanosizing, and reviews literature on quantitatively studying the effect of particle size and surface area on initial dissolution rate enhancement.
This presentation involves the information about Modified-Release Drug Products, Targeted Drug Delivery Systems and Biotechnological Products in Pharmaceutics
This document discusses the importance of preformulation studies in designing sustained release dosage forms. Preformulation studies provide important information about the drug substance including solubility, pH effects, partitioning, stability and compatibility with excipients. This information guides the selection of appropriate formulation components, manufacturing processes and container closure systems. Key preformulation tests described include determining intrinsic solubility, dissociation constant (pKa), partition coefficient, crystal properties, and dissolution rate. The results of preformulation studies help develop stable, bioavailable sustained release dosage forms that can be mass produced.
This document discusses the importance of preformulation studies in designing sustained release dosage forms. Preformulation studies provide important information about the drug substance that can be used to develop stable and bioavailable sustained release formulations. Key aspects of preformulation include determining solubility, pKa, partition coefficient, crystal properties, and compatibility with excipients. This information helps select appropriate formulation components, manufacturing processes, container closure systems and more. The overall goal of preformulation is to generate data to support the development of sustained release dosage forms that can be mass produced and provide a prolonged therapeutic effect.
review on gastroretentive drug delivery systemsMaedeh Haedi
This document discusses gastroretentive drug delivery systems (GRDDS). GRDDS are used to prolong the gastric residence time and target drug release in the upper gastrointestinal tract. There are various types of GRDDS including floating systems, expandable systems, and mucoadhesive systems. The document discusses factors that affect GRDDS performance such as pharmaceutical factors like polymer selection and dosage form properties, as well as physiological factors. Specific polymers commonly used in GRDDS formulations are also described, such as sodium alginate, carbopol, and hydroxypropyl methylcellulose.
This document describes the development and evaluation of carvedilol phosphate gastroretentive floating tablets using a 32 factorial design. Carvedilol phosphate is a drug that belongs to BCS Class II and is indicated for hypertension and heart failure. Floating tablets were prepared using varying concentrations of guar gum and sodium bicarbonate as polymers to control the release of the water soluble drug. Nine formulations were designed and evaluated for properties like drug content, floating lag time, and in vitro drug release using kinetic models. The results showed that all formulations met pharmacopeial standards and formulation F8 containing 25% guar gum and 3.75% sodium bicarbonate best matched the marketed product with respect to drug release.
Biopharmaceutics is the study of physicochemical properties of drugs and how they influence the drug's bioavailability. Key factors that can impact bioavailability include the drug's solubility, dissolution rate, and permeability. For an orally administered drug, the drug must first dissolve in the gastrointestinal fluids before it can be absorbed through the gastrointestinal membranes and enter systemic circulation. The rate of dissolution is often the slowest step and thus rate-limiting for poorly water soluble drugs. Techniques such as reducing particle size, use of salt forms, and amorphous forms can increase dissolution rate and bioavailability.
In recent years many advancement has been made in research and development of Oral Drug Delivery System. Concept of Novel Drug Delivery System arose to overcome the certain aspect related to physicochemical properties of drug molecule and the related formulations.
Purpose of this review is to compile the recent literature with special focus on Gastro Retentive Drug Delivery Systems to give an update
on pharmaceutical approaches used in enhancing the Gastric Residence Time (GRT). Various approaches are currently used including Gastro Retentive Floating Drug Delivery Systems(GRFDDS),swelling and expanding system, polymeric bioadhesive systems, modifiedshape
systems, high density system and other delayed gastric emptying devices. These systems are very helpful to different problem solve during the formulation of different dosage form. The present work also focuses on the polymers used in floating drug delivery systems
mostly from natural origin. Floating drug delivery systems are less dense than gastric fluids; hence remain buoyant in the upper GIT for a
prolonged period, releasing the drug at the desired/ predeterminedrate. This review article focuses on the recent technological development in floating drug delivery systems with special emphasis on the principal mechanism of floatation and advantages of achieving gastric
retention, brief collection on various polymers employed for floating drug delivery systems etc. In addition this review also summarizes the In –Vitro and In -Vivo studies to evaluate their performance and also their future potential.
This document discusses modified release drug products, including extended release and delayed release dosage forms. It defines modified release as altering the timing and/or rate of drug release. Extended release aims for twice daily dosing by providing continuous drug levels while delayed release releases the drug at a time other than promptly after administration. The document discusses various extended release drug delivery technologies like coated beads, multilayer tablets, microencapsulation, embedding in eroding matrices, plastic matrices, complexation, and osmotic pumps. It emphasizes the importance of in vitro-in vivo correlations and bioequivalence studies in evaluating these modified release products.
This document summarizes research on the development and evaluation of gastric floating tablets for controlled delivery of three antiplatelet drugs: prasugrel hydrochloride, clopidogrel bisulfate, and dipyridamole. The drugs were selected based on their similar physicochemical properties and pH-dependent solubility. Floating drug delivery systems were developed using hydrophilic HPMC K100M and hydrophobic Compritol 888 ATO polymers alone and in combination to study their effects on drug release. Tablets were prepared by effervescent techniques with melt granulation and direct compression. In vitro tests found that formulations with polymer blends provided more sustained drug release over 8 hours compared to formulations with single polymers.
This document describes research into developing gastric floating tablets of three anti-platelet drugs (prasugrel hydrochloride, clopidogrel bisulfate, and dipyridamole) to enhance their bioavailability and minimize side effects. The drugs were selected based on their similar physicochemical properties and pH-dependent solubility. Floating drug delivery systems were developed using combinations of the hydrophilic polymer HPMC K100M and hydrophobic polymer Compritol 888 ATO to control the initial drug release rate. Tablets were prepared by melt granulation and direct compression. The solubility, compatibility, physical properties, and in vitro floating behavior of formulations containing different polymer concentrations were evaluated. Formulations containing both polymers
Bioavailability and bioequivalence studyMcpl Moshi
BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
Kashikar V S
PES Modern College of Pharmacy ( for ladies), Moshi Pune
Bioavailability and Bioequivalence studyMcpl Moshi
Bioavailability and Bioequivalence study, BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
ABSTRACT
The main objective of present investigation is to formulate the sustained release tablet of Zidovudine using 32
factorial design. Zidovudine, antiretroviral drug belongs to BCS Class I. The SR tablets of Zidovudine were
prepared employing different concentrations of Carboplol974P and Xanthan gum in different combinations as a
rate retardants by Direct Compression technique using 32 factorial design. The quantity of rate retarders,
Carboplol974P and Xanthan gum required to achieve the desired drug release was selected as independent
variables, X1 and X2 respectively whereas, time required for 10% of drug dissolution (t10%), 50% (t50%), 75% (t75%)
and 90% (t90%) were selected as dependent variables. Totally nine formulations were designed and are evaluated
for hardness, friability, thickness, % drug content, In-vitro drug release. From the Results it was concluded that all
the formulation were found to be with in the Pharmacopoeial limits and the In-vitro dissolution profiles of all
formulations were fitted in to different Kinetic models, the statistical parameters like intercept (a), slope (b) &
regression coefficient (r) were calculated. Polynomial equations were developed for t10%, t50%, t75%, t90%. Validity of
developed polynomial equations were verified by designing 2 check point formulations(C1, C2). According to
SUPAC guidelines the formulation (F5) containing combination of 5% Carboplol974P and 5% Xanthan gum, is the
most similar formulation (f2=85.04 & No significant difference, t= 0.20046) to marketed product (Retrovir). The
selected formulation (F5) follows Higuchi’s kinetics, the mechanism of drug release was found to be Case-II
transport or typical Zero order release (Non-Fickian, n= 0.915).
The document discusses the formulation and evaluation of an artemether sustained release floating bilayer tablet. It aims to develop a floating drug delivery system for artemether to increase its gastric residence time and provide sustained release to ensure optimal drug levels in the blood and minimize side effects. The document provides background on floating drug delivery systems and reviews previous literature on developing such systems for other drugs. It then gives information on the drug artemether and outlines the objectives and methodology that will be used in the study.
ABSTRACT
The main objective of present research work is to formulate the of Domperidone Maleate floating tablets.
Domperidone Maleate, an antiemetic and a prokinetic agent belongs to BCS Class-II and Indicated for treatment of
upper gastrointestinal motility disorders by blocking the action of Dopamine. The Floating tablets of Domperidone
Maleate were prepared employing different concentrations of HPMCK4M and Guar Gum in different combinations
as a release rate modifiers by Direct Compression technique using 32 factorial design. The concentration of
HPMCK4M and Guar Gum was selected as independent variables, X1 and X2 respectively whereas, time required
for drug dissolution t10%, t50%,t75%,t90%were selected as dependent variables. Totally nine formulations were designed
and are evaluated for hardness, friability, thickness, Assay, Floating Lag time, In-vitro drug release. From the
Results concluded that all the formulation were found to be with in the Pharmacopoeial limits and the In-vitro
dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like
intercept (a), slope (b) & regression coefficient (r) were calculated. Polynomial equations were developed for t10%,
t50%, t75%, t90%. Validity of developed polynomial equations were verified by designing 2 check point formulations(C1,
C2). According to SUPAC guidelines the formulation (F5) containing combination of 18.75% HPMCK4M and
18.75% Guar Gum, is the most similar formulation (similarity factor f2=89.03, dissimilarity factor f1= 11.539& No
significant difference, t= 0.169) to marketed product (DOMSTAL OD). The selected formulation (F5) follows
Higuchi’s kinetics, and the mechanism of drug release was found to be Non-Fickian Diffusion (n= 0.925).
Keywords: Domperidone Maleate, 32Factorial Design, Gastro retentive Floating Tablet, HPMCK100M, Sodium
bicarbonate, Floating Lag Time, SUPAC, Non-Fickian Diffusion Mechanism.
Formulation of Timolol Maleate Sustained-release Matrix TabletsBRNSSPublicationHubI
This document describes the formulation of sustained-release matrix tablets of timolol maleate using different grades of hydroxypropyl methylcellulose (HPMC) polymers. Timolol maleate matrix tablets were prepared by wet granulation method using HPMC K100M and HPMC K15M polymers. Tablet formulations containing a combination of HPMC K100M and HPMC K15M (batches F26 to F30) provided drug release for over 10 hours. No significant change in drug release was observed with changing the polymer ratio. All batches showed some initial burst release as well. The release mechanism was determined to be anomalous diffusion or diffusion coupled with erosion.
Formulation and Evaluation of Stavudine Controlled Release Matrix TabletSunil Vadithya
The document presents a study on the formulation and evaluation of controlled release matrix tablets of Stavudine. Stavudine was selected as a model drug due to its short half-life. Hydroxypropyl methylcellulose (HPMC) and Carbopol 934 were used as release retarding polymers to develop sustained release matrix tablets. Tablets were prepared by direct compression method and evaluated for physical parameters, drug content, swelling index and in-vitro drug release up to 8 hours. The results showed that formulations containing higher proportions of polymers released the drug in a controlled manner for an extended period of time.
A Review- Pharmaceutical and Pharmacokinetic Aspect of Nanocrystalline Suspen...Dhaval shah
This document reviews pharmaceutical and pharmacokinetic aspects of nanocrystalline suspensions. It discusses how nanocrystals have emerged as a potential formulation strategy to enhance dissolution rate and solubility for poorly soluble drugs. The review provides an in-depth look at processing methods, quantitative assessments of solubility and dissolution rates, and their correlation to pharmacokinetic data. It also discusses the lack of understanding around changes in thermodynamic and kinetic properties like solubility and dissolution rate upon nanosizing, and reviews literature on quantitatively studying the effect of particle size and surface area on initial dissolution rate enhancement.
A Review- Pharmaceutical and Pharmacokinetic Aspect of Nanocrystalline Suspen...Dhaval shah
This document reviews pharmaceutical and pharmacokinetic aspects of nanocrystalline suspensions. It discusses how nanocrystals have emerged as a potential formulation strategy to enhance dissolution rate and solubility for poorly soluble drugs. The review provides an in-depth look at processing methods, quantitative assessments of solubility and dissolution rates, and their correlation to pharmacokinetic data. It also discusses the lack of understanding around changes in thermodynamic and kinetic properties like solubility and dissolution rate upon nanosizing, and reviews literature on quantitatively studying the effect of particle size and surface area on initial dissolution rate enhancement.
This presentation involves the information about Modified-Release Drug Products, Targeted Drug Delivery Systems and Biotechnological Products in Pharmaceutics
This document discusses the importance of preformulation studies in designing sustained release dosage forms. Preformulation studies provide important information about the drug substance including solubility, pH effects, partitioning, stability and compatibility with excipients. This information guides the selection of appropriate formulation components, manufacturing processes and container closure systems. Key preformulation tests described include determining intrinsic solubility, dissociation constant (pKa), partition coefficient, crystal properties, and dissolution rate. The results of preformulation studies help develop stable, bioavailable sustained release dosage forms that can be mass produced.
This document discusses the importance of preformulation studies in designing sustained release dosage forms. Preformulation studies provide important information about the drug substance that can be used to develop stable and bioavailable sustained release formulations. Key aspects of preformulation include determining solubility, pKa, partition coefficient, crystal properties, and compatibility with excipients. This information helps select appropriate formulation components, manufacturing processes, container closure systems and more. The overall goal of preformulation is to generate data to support the development of sustained release dosage forms that can be mass produced and provide a prolonged therapeutic effect.
review on gastroretentive drug delivery systemsMaedeh Haedi
This document discusses gastroretentive drug delivery systems (GRDDS). GRDDS are used to prolong the gastric residence time and target drug release in the upper gastrointestinal tract. There are various types of GRDDS including floating systems, expandable systems, and mucoadhesive systems. The document discusses factors that affect GRDDS performance such as pharmaceutical factors like polymer selection and dosage form properties, as well as physiological factors. Specific polymers commonly used in GRDDS formulations are also described, such as sodium alginate, carbopol, and hydroxypropyl methylcellulose.
This document describes the development and evaluation of carvedilol phosphate gastroretentive floating tablets using a 32 factorial design. Carvedilol phosphate is a drug that belongs to BCS Class II and is indicated for hypertension and heart failure. Floating tablets were prepared using varying concentrations of guar gum and sodium bicarbonate as polymers to control the release of the water soluble drug. Nine formulations were designed and evaluated for properties like drug content, floating lag time, and in vitro drug release using kinetic models. The results showed that all formulations met pharmacopeial standards and formulation F8 containing 25% guar gum and 3.75% sodium bicarbonate best matched the marketed product with respect to drug release.
Biopharmaceutics is the study of physicochemical properties of drugs and how they influence the drug's bioavailability. Key factors that can impact bioavailability include the drug's solubility, dissolution rate, and permeability. For an orally administered drug, the drug must first dissolve in the gastrointestinal fluids before it can be absorbed through the gastrointestinal membranes and enter systemic circulation. The rate of dissolution is often the slowest step and thus rate-limiting for poorly water soluble drugs. Techniques such as reducing particle size, use of salt forms, and amorphous forms can increase dissolution rate and bioavailability.
In recent years many advancement has been made in research and development of Oral Drug Delivery System. Concept of Novel Drug Delivery System arose to overcome the certain aspect related to physicochemical properties of drug molecule and the related formulations.
Purpose of this review is to compile the recent literature with special focus on Gastro Retentive Drug Delivery Systems to give an update
on pharmaceutical approaches used in enhancing the Gastric Residence Time (GRT). Various approaches are currently used including Gastro Retentive Floating Drug Delivery Systems(GRFDDS),swelling and expanding system, polymeric bioadhesive systems, modifiedshape
systems, high density system and other delayed gastric emptying devices. These systems are very helpful to different problem solve during the formulation of different dosage form. The present work also focuses on the polymers used in floating drug delivery systems
mostly from natural origin. Floating drug delivery systems are less dense than gastric fluids; hence remain buoyant in the upper GIT for a
prolonged period, releasing the drug at the desired/ predeterminedrate. This review article focuses on the recent technological development in floating drug delivery systems with special emphasis on the principal mechanism of floatation and advantages of achieving gastric
retention, brief collection on various polymers employed for floating drug delivery systems etc. In addition this review also summarizes the In –Vitro and In -Vivo studies to evaluate their performance and also their future potential.
This document discusses modified release drug products, including extended release and delayed release dosage forms. It defines modified release as altering the timing and/or rate of drug release. Extended release aims for twice daily dosing by providing continuous drug levels while delayed release releases the drug at a time other than promptly after administration. The document discusses various extended release drug delivery technologies like coated beads, multilayer tablets, microencapsulation, embedding in eroding matrices, plastic matrices, complexation, and osmotic pumps. It emphasizes the importance of in vitro-in vivo correlations and bioequivalence studies in evaluating these modified release products.
This document summarizes research on the development and evaluation of gastric floating tablets for controlled delivery of three antiplatelet drugs: prasugrel hydrochloride, clopidogrel bisulfate, and dipyridamole. The drugs were selected based on their similar physicochemical properties and pH-dependent solubility. Floating drug delivery systems were developed using hydrophilic HPMC K100M and hydrophobic Compritol 888 ATO polymers alone and in combination to study their effects on drug release. Tablets were prepared by effervescent techniques with melt granulation and direct compression. In vitro tests found that formulations with polymer blends provided more sustained drug release over 8 hours compared to formulations with single polymers.
This document describes research into developing gastric floating tablets of three anti-platelet drugs (prasugrel hydrochloride, clopidogrel bisulfate, and dipyridamole) to enhance their bioavailability and minimize side effects. The drugs were selected based on their similar physicochemical properties and pH-dependent solubility. Floating drug delivery systems were developed using combinations of the hydrophilic polymer HPMC K100M and hydrophobic polymer Compritol 888 ATO to control the initial drug release rate. Tablets were prepared by melt granulation and direct compression. The solubility, compatibility, physical properties, and in vitro floating behavior of formulations containing different polymer concentrations were evaluated. Formulations containing both polymers
Bioavailability and bioequivalence studyMcpl Moshi
BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
Kashikar V S
PES Modern College of Pharmacy ( for ladies), Moshi Pune
Bioavailability and Bioequivalence studyMcpl Moshi
Bioavailability and Bioequivalence study, BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
ABSTRACT
The main objective of present investigation is to formulate the sustained release tablet of Zidovudine using 32
factorial design. Zidovudine, antiretroviral drug belongs to BCS Class I. The SR tablets of Zidovudine were
prepared employing different concentrations of Carboplol974P and Xanthan gum in different combinations as a
rate retardants by Direct Compression technique using 32 factorial design. The quantity of rate retarders,
Carboplol974P and Xanthan gum required to achieve the desired drug release was selected as independent
variables, X1 and X2 respectively whereas, time required for 10% of drug dissolution (t10%), 50% (t50%), 75% (t75%)
and 90% (t90%) were selected as dependent variables. Totally nine formulations were designed and are evaluated
for hardness, friability, thickness, % drug content, In-vitro drug release. From the Results it was concluded that all
the formulation were found to be with in the Pharmacopoeial limits and the In-vitro dissolution profiles of all
formulations were fitted in to different Kinetic models, the statistical parameters like intercept (a), slope (b) &
regression coefficient (r) were calculated. Polynomial equations were developed for t10%, t50%, t75%, t90%. Validity of
developed polynomial equations were verified by designing 2 check point formulations(C1, C2). According to
SUPAC guidelines the formulation (F5) containing combination of 5% Carboplol974P and 5% Xanthan gum, is the
most similar formulation (f2=85.04 & No significant difference, t= 0.20046) to marketed product (Retrovir). The
selected formulation (F5) follows Higuchi’s kinetics, the mechanism of drug release was found to be Case-II
transport or typical Zero order release (Non-Fickian, n= 0.915).
ALPHA LOGARITHM TRANSFORMED SEMI LOGISTIC DISTRIBUTION USING MAXIMUM LIKELIH...BRNSS Publication Hub
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This document summarizes research on the split and non-split domination numbers of tenement graphs. It defines tenement graphs and provides basic definitions of domination, split domination, and non-split domination. Formulas for the split and non-split domination numbers of tenement graphs are presented based on the number of vertices. Theorems are presented stating that the mid vertex set of a tenement graph is always a split dominating set, but its size is not always equal to the split domination number.
This document summarizes research on generalized Cantor sets and functions where the standard construction is modified. It introduces Cantor sets defined by an arbitrary base where the intervals removed at each stage are not all the same length. It also defines irregular or transcendental Cantor sets generated by transcendental numbers like e. The key findings are:
1) There exists a unique probability measure for generalized Cantor sets that generates the cumulative distribution function.
2) The Holder exponent of generalized Cantor sets is shown to be logn/s where n is the base and s is the number of subintervals.
3) Lower and upper densities are defined for the measure on generalized Cantor functions and their properties are
SYMMETRIC BILINEAR CRYPTOGRAPHY ON ELLIPTIC CURVE AND LIE ALGEBRABRNSS Publication Hub
1) The document discusses symmetric bilinear pairings on elliptic curves and Lie algebras in the context of cryptography. It provides an overview of the theoretical foundations and applications of combining these areas.
2) Key concepts covered include the Weil pairing as a symmetric bilinear pairing on elliptic curves, its properties of bilinearity and non-degeneracy, and efficient computation. Applications of elliptic curves in cryptography like ECDH and ECDSA are also summarized.
3) The security of protocols like ECDH and ECDSA relies on the assumed difficulty of solving the elliptic curve discrete logarithm problem (ECDLP). The document proves various mathematical aspects behind symmetric bilinear pairings and their use in elliptic curve cryptography.
SUITABILITY OF COINTEGRATION TESTS ON DATA STRUCTURE OF DIFFERENT ORDERSBRNSS Publication Hub
This document summarizes research investigating the suitability of cointegration tests on time series data of different orders. The researchers used simulated time series data from normal and gamma distributions at sample sizes of 30, 60, and 90. Three cointegration tests (Engle-Granger, Johansen, and Phillips-Ouliaris) were applied to the data. The tests were assessed based on type 1 error rates and power to determine which test was most robust for different distributions and sample sizes. The results indicated the Phillips-Ouliaris test was generally the most effective at determining cointegration across different sample sizes and distributions.
Artificial Intelligence: A Manifested Leap in Psychiatric RehabilitationBRNSS Publication Hub
Artificial intelligence shows promise in improving psychiatric rehabilitation in 3 key ways:
1) AI can help diagnose and treat mental health issues through virtual therapists and chatbots, improving access and reducing stigma.
2) Technologies like machine learning and big data allow personalized interventions and more accurate diagnoses.
3) The COVID-19 pandemic has increased need for mental health support, and AI may help address gaps by providing remote services.
A Review on Polyherbal Formulations and Herbal Medicine for Management of Ul...BRNSS Publication Hub
This document provides a review of polyherbal formulations and herbal medicines for treating peptic ulcers. It discusses how peptic ulcers occur due to an imbalance between aggressive and protective factors in the gastrointestinal tract. Common causes include H. pylori infection and NSAID use. While synthetic medications are available, herbal supplements are more affordable and have fewer side effects. The review examines various herbs that have traditionally been used to treat ulcers, including their active chemical constituents. It defines polyherbal formulations as combinations of two or more herbs, which can enhance therapeutic effects while reducing toxicity. The document aims to summarize recent research on herb and polyherbal formulation treatments for peptic ulcers.
Current Trends in Treatments and Targets of Neglected Tropical DiseaseBRNSS Publication Hub
This document summarizes current trends in treatments and targets of neglected tropical diseases. It begins by stating that neglected tropical diseases affect over 1.7 billion people globally each year and are caused by a variety of microbes. The World Health Organization is working to eliminate 30 neglected tropical diseases by 2030. The document then discusses several specific neglected tropical diseases in more detail, including human African trypanosomiasis, Chagas disease, leishmaniasis, soil-transmitted helminths, and schistosomiasis. It describes the causative agents, transmission methods, symptoms, affected populations, and current treatment options for each of these diseases. Overall, the document aims to briefly discuss neglected infectious diseases and treatment
Evaluation of Cordia Dichotoma gum as A Potent Excipient for the Formulation ...BRNSS Publication Hub
This document summarizes a study that evaluated Cordia dichotoma gum as an excipient for oral thin film drug delivery. Films were prepared with varying ratios of the gum, plasticizers (methyl paraben and glycerine), and the model drug diclofenac sodium. The films were evaluated for properties like thickness, folding endurance, tensile strength, water uptake, and drug release kinetics. The results found that a film with 10% gum, 0.2% methyl paraben and 2.5% glycerine (CDF3) exhibited the best results among the formulations tested. Stability studies showed the films were stable for 30 days at different temperatures. Overall, the study demonstrated that C.
Assessment of Medication Adherence Pattern for Patients with Chronic Diseases...BRNSS Publication Hub
This study assessed medication adherence and knowledge among rural patients with chronic diseases in South Indian hospitals. 1500 hypertensive patients were divided into intervention and control groups. The intervention group received education from pharmacists at various times, while the control group did not. A questionnaire evaluated patients' medication knowledge at baseline and several follow-ups. The intervention group showed improved medication knowledge scores after education compared to the control group. Female gender, lower education, and income were linked to lower knowledge. The study highlights the need to educate rural patients to improve medication understanding and adherence.
This document proposes a system to hide information using four algorithms for image steganography. The system first encrypts data using a modified AES algorithm. It then encrypts the encrypted data using a modified RSA algorithm. Next, it uses a fuzzy stream algorithm to add ambiguity. Finally, it hides the encrypted data in the least significant bits of cover images using LSB steganography. The document evaluates the proposed system using metrics like PSNR, MSE, and SSIM to analyze image quality and the ability to hide data imperceptibly compared to other techniques. It selects four color images as cover files and tests the system on them.
The document discusses Goldbach's problems and their solutions. It summarizes that the ternary Goldbach problem, which states that every odd number greater than 7 can be represented as the sum of three odd primes, was solved in 2013. It also discusses Ramare's 1995 proof that any even number can be represented as the sum of no more than 6 primes. The document then provides proofs for theorems related to representing numbers as sums of primes and concludes there are an infinite number of twin primes.
The document summarizes research on k-super contra harmonic mean labeling of graphs. It defines k-super Lehmer-3 mean labeling of a graph as an injective vertex labeling such that the induced edge labels satisfy certain properties. It proves that several families of graphs admit k-super Lehmer-3 mean labeling for any positive integer k, including triangular snakes, double triangular snakes, alternative triangular snakes, quadrilateral snakes, and alternative quadrilateral snakes. The document introduces the concept of k-super Lehmer-3 mean labeling and investigates this property for these families of graphs.
The document summarizes research on using various iterative schemes to solve fixed-point problems and inequalities involving self-mappings and contractions in Banach spaces. It defines concepts like non-expansive mappings, mean non-expansive mappings, and rates of convergence. The paper presents two theorems: 1) an iterative scheme for a sequence involving a self-mapping T is shown to converge to a fixed point of T, and 2) an iterative process involving a self-contraction mapping T is defined and shown to converge. Limiting cases are considered to prove convergence as the number of iterations approaches infinity.
This document summarizes research on analyzing and simulating the accuracy and stability of closed-loop control systems. It discusses various techniques for evaluating accuracy and stability, including steady-state error analysis, stability analysis, and simulation. Factors that can affect accuracy and stability are also identified, such as sensor noise, model inaccuracies, and environmental disturbances. The paper provides an overview of closed-loop control systems and their uses in various engineering fields like manufacturing, chemical processes, vehicles, aircraft, and power systems.
The simplified electron and muon model, Oscillating Spacetime: The Foundation...RitikBhardwaj56
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How to Add Chatter in the odoo 17 ERP ModuleCeline George
In Odoo, the chatter is like a chat tool that helps you work together on records. You can leave notes and track things, making it easier to talk with your team and partners. Inside chatter, all communication history, activity, and changes will be displayed.
LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UPRAHUL
This Dissertation explores the particular circumstances of Mirzapur, a region located in the
core of India. Mirzapur, with its varied terrains and abundant biodiversity, offers an optimal
environment for investigating the changes in vegetation cover dynamics. Our study utilizes
advanced technologies such as GIS (Geographic Information Systems) and Remote sensing to
analyze the transformations that have taken place over the course of a decade.
The complex relationship between human activities and the environment has been the focus
of extensive research and worry. As the global community grapples with swift urbanization,
population expansion, and economic progress, the effects on natural ecosystems are becoming
more evident. A crucial element of this impact is the alteration of vegetation cover, which plays a
significant role in maintaining the ecological equilibrium of our planet.Land serves as the foundation for all human activities and provides the necessary materials for
these activities. As the most crucial natural resource, its utilization by humans results in different
'Land uses,' which are determined by both human activities and the physical characteristics of the
land.
The utilization of land is impacted by human needs and environmental factors. In countries
like India, rapid population growth and the emphasis on extensive resource exploitation can lead
to significant land degradation, adversely affecting the region's land cover.
Therefore, human intervention has significantly influenced land use patterns over many
centuries, evolving its structure over time and space. In the present era, these changes have
accelerated due to factors such as agriculture and urbanization. Information regarding land use and
cover is essential for various planning and management tasks related to the Earth's surface,
providing crucial environmental data for scientific, resource management, policy purposes, and
diverse human activities.
Accurate understanding of land use and cover is imperative for the development planning
of any area. Consequently, a wide range of professionals, including earth system scientists, land
and water managers, and urban planners, are interested in obtaining data on land use and cover
changes, conversion trends, and other related patterns. The spatial dimensions of land use and
cover support policymakers and scientists in making well-informed decisions, as alterations in
these patterns indicate shifts in economic and social conditions. Monitoring such changes with the
help of Advanced technologies like Remote Sensing and Geographic Information Systems is
crucial for coordinated efforts across different administrative levels. Advanced technologies like
Remote Sensing and Geographic Information Systems
9
Changes in vegetation cover refer to variations in the distribution, composition, and overall
structure of plant communities across different temporal and spatial scales. These changes can
occur natural.
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Main Java[All of the Base Concepts}.docxadhitya5119
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How to Make a Field Mandatory in Odoo 17Celine George
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Executive Directors Chat Leveraging AI for Diversity, Equity, and InclusionTechSoup
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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 Fix the Import Error in the Odoo 17Celine George
An import error occurs when a program fails to import a module or library, disrupting its execution. In languages like Python, this issue arises when the specified module cannot be found or accessed, hindering the program's functionality. Resolving import errors is crucial for maintaining smooth software operation and uninterrupted development processes.
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.
His expertise extends across a diverse spectrum of reporting, database, and web development applications, underpinned by an exceptional grasp of data storage and virtualization technologies. His proficiency in application testing, database administration, and data cleansing ensures seamless execution of complex projects.
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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How to Manage Your Lost Opportunities in Odoo 17 CRMCeline George
Odoo 17 CRM allows us to track why we lose sales opportunities with "Lost Reasons." This helps analyze our sales process and identify areas for improvement. Here's how to configure lost reasons in Odoo 17 CRM
2. Lalitha: Formulation and Evaluation of Gastroretentive
IJPBA/Jul-Sep-2021/Vol 12/Issue 3 119
circulation of high drug concentration often
induces the adverse effect, because in this case,
drug delivery solely depends on simple diffusion or
partition from blood stream to target site. Only one
advantage of conventional formulations is that the
cost of development is low [Figure 1].
Gastroretentive Drug Delivery Systems
(GRDDS)[5]
Dosage forms that can be retained in the stomach
are called GRDDS. GRDDS can improve controlled
delivery of drugs with an absorption window by
continuously releasing the drug for a prolonged
period before it reaches its absorption site, thus
ensuring optimal bioavailability. Drugs with a
narrow absorption window are mostly associated
with improved absorption at the jejunum and ileum
due to the enhanced absorption properties of these
sites (e.g. large surface area), or because of enhanced
solubilityinthestomachasopposedtothemoredistal
parts of the gastrointestinal tract (GIT) [Figure 2].
Factors Controlling Gastric Retention of
Dosage Forms[6]
The gastric retention time (GRT) of dosage forms
is controlled by several factors such as density and
size of the dosage form, food intake, nature of the
food, posture, age, sex, sleep, and disease state
of the individual (e.g, gastrointestinal diseases
and diabetes) and administration of drugs such as
prokinetic agents (cisapride and metoclopramide).
Floating Systems
Floating drug delivery systems (FDDSs) have a
bulk density less than gastric fluids and so remain
buoyant in the stomach without affecting gastric
emptying rate for a prolonged period of time
[Figure 3]. While the system is floating on the
gastric contents, the drug is released slowly at the
desired rate from the system. After release of drug,
the residual system is emptied from the stomach.
Figure 1: Different types of controlled release systems. (a) Drug delivery based on simple diffusion and partition.
(b) Sustained release to prolong the therapeutic period. (c) Pulsatile release to tightly maintain homeostasis. (d) Release
profile and drug conversion of the polymer drug conjugate as a prodrug. (e) Temporally controlled (or sequential) release
profile of multiple drugs. (f) Onsite release to maximize therapeutic efficiency and to minimize side effect
a b c
e f
d
Figure 2: Drug absorption in (a) conventional dosage forms
and (b) gastroretentive drug delivery systems
a b
3. Lalitha: Formulation and Evaluation of Gastroretentive
IJPBA/Jul-Sep-2021/Vol 12/Issue 3 120
This results in an increased GRT and a better control
of the fluctuations in plasma drug concentration.[7-15]
Melt Granulation
Melt granulation or pelletization is a one-step
process allowing the transformation of a powder mix
(containing the drug) into granules or spheronized
pellets. The technique necessitates high shear mixing
in the presence of a meltable binder which may be
sprayed in molten state onto the powder mix as in
classic wet granulation process. This is referred to as
“pump-on”technique.Alternatively,thebindermaybe
blended with the powder mix in its solid or semi-solid
state and allowed to melt (partially or completely) by
the heat generated from the friction of particles during
high shear mixing referred to “melt-in” process. The
melted binder forms liquid bridges with the powder
particlesthatshapeintosmallagglomerates(granules)
which can by further mixing under controlled
conditions transform to spheronized pellets.
Melt granulation is one of the most applied
processingtechniquesinthearrayofpharmaceutical
manufacturing operations. Melt granulation
process is currently applied in the pharmaceutical
manufacturing operations for manufacture of
variety of dosage forms and formulations such as
immediate release pellets, granules, and tablets.
Modes of Melt Granulation
Materials used in melt granulation[5,6,16-23]
Lipids are considered as an alternative to polymer in
the design of sustained drug delivery systems due to
their advantages such as the low melt viscosity (thus
avoidingtheneedoforganicsolventsforsolubilization)
absence of toxic impurities such as residual monomer
catalysis and initiators, potential biocompatibility, and
biodegradability. The various meltable binders for the
sustained drug delivery mentioned in Tables 1 and 2.
Drug Profile and Polymer Profile
Drug profile
Lamivudine Description: White, amorphous
powder and hygroscopic
Category: Antiretroviral, reverse transcriptase
inhibitor (nucleoside)
Structure:
Chemical name: 1-((2R, 5S)-5-(hydroxymethyl)-2,
5-dihydrofuran-2-yl) - 5- methylpyrimidine-2,
4(1H, 3H)-dione
Table 1: Hydrophilic meltable binders in the melt
granulation technique
Hydrophilic meltable binder Typical melting range (°C)
Gelucire 50/13
Poloxamer 188
Polyethylene glycol 2000
3000
6000
8000
10,000
20,000
Stearate 6000 WL1644
44–50
50.9
42–53
48–63
49–63
54–63
57–64
53–66
46–58
Table 2: Hydrophobic meltable binders in the melt
granulation technique
Hydrophobic meltable binder Typical melting range (°C)
Beeswax
Carnauba wax
Cetyl palmitate
Glyceryl behenate
Glyceryl monostearate
Glyceryl palmitostearate
Glyceryl stearate
Hydrogenated castor oil
Microcrystalline wax
Paraffin wax
56–60
75–83
47–50
67–75
47–63
48–57
54–63
62–86
58–72
47–65
Figure 3: Modes of melt agglomeration: (a) Distribution
and (b) immersion
a
b
4. Lalitha: Formulation and Evaluation of Gastroretentive
IJPBA/Jul-Sep-2021/Vol 12/Issue 3 121
Molecular formula: C10
H12
N2
O4
Molecular weight: 224.2
Solubility: Soluble in water and sparingly soluble
in ethanol (95%)
Storage: Store in a well-closed container, protected
from light
Specific rotation: Between −39.0° and −46.0°,
determined in a 0.7% W/V solution in water.
Sulfated ash: Not more than 0.3%
Loss on drying: Not more than 20 ppm, determined
on 1.0 g by drying at 105° for 3 h.
Polymer profile
Hydroxypropyl methylcellulose (HPMC)
Name: HPMC, Chemical name: Cellulose,
2-hydroxylpropylmethyl ether Common name:
Methocel, hypromellose
Appearance: White or off-white power with
odorless and tasteless.
Carbonation temperature: 280–300°C.
Solubility: Dissolves in water, some organic
solvents or some water organic components. Hardly
dissolves in waterless ethanol, ether, or acetone.
Expands to clear or slightly muddy colloid solution
in cold water.
Apparent density: 0.25–0.70 g/cm3
Specific gravity: 1.26–1.31.
Applications: Suspending agent, viscosity modifier,
film, and matrix forming material, tablet binder,
and adhesive ointment ingredient.
Stability: It is very stable in dry condition
from pH 3.0 to 11.0. Aqueous solutions are
liable to be affected by microorganisms. It has
attracted significant attention for drug delivery
applications. It remains glossy in dehydrated
state and swollen in the presence of water to form
an elastic gel. It is categorized under the class
“hydrogels.” It is soluble in cold water, insoluble
in alcohol, ether, and chloroform but soluble in
mixture of methylene chloride and methanol. It is
very stable in dry condition from pH 3.0 to 11.0.
Aqueous solutions are liable to be affected by
microorganism (Handbook Pharmaceutical
Excipients, 2005).[24]
MATERIALS AND EQUIPMENTS
[TABLES 3 AND 4]
Dose Calculation
The amount of drug required in a controlled release
dosage form, to provide a sustained drug level in
the body is determined by the pharmacokinetics of
the drug, the desired therapeutic level of the drug,
and the intended duration of action. The objective
of this calculation is to arrive at the theoretical
amount of drug that must be present in the FDDS,
being administered once a day and capable of
acting up to 12 h. In general, the total dose required
(DTotal) is the sum of the maintenance dose (DM)
and the initial dose (DI) immediately released to
provide a therapeutic blood level.
DTotal = DI + DM
Table 3: Materials used in the work
S. No. Materials Vendor
1 Lamivudine A generous gift from Dr. REDDY’S
Laboratories, Hyderabad
2 Gelucire 43/01 A generous gift from GATTEFOSSE
Corp, France
3 HPMC K100M A generous gift from ISP Hongkong Pvt.
Ltd., Hyderabad.
4 HPMC K4M A generous gift from ISP Hongkong Pvt.
Ltd., Hyderabad
5 Compritol 888 ATO A generous gift from Shasun
Pharmaceuticals Pvt. Ltd., Pondicherry
6 Precirol ATO 5 A generous gift from Shasun
Pharmaceuticals Pvt. Ltd., Pondicherry
7 Lubritab A generous gift from Aurobindo Pharma
Pvt. Ltd., Hyderabad
8 Cremophor A generous gift from Aurobindo Pharma
Pvt. Ltd., Hyderabad
Table 4: Equipment used in the work
S. No. Equipment Manufacturer Model No
1 Electronic Single Pan
Balance
Shimadzu GP3202
2 Dissolution apparatus Lab India Disso 2000
3 UV spectrophotometer Cyberlab 3220 UV
4 IR spectrophotometer Nicolet 5700
5 DSC Breeze DSCQ1000
6 Heating mantle Biotechniques, India BTIL
7 Hot pan Remi Equipment 1MLH
8 Flask shaker Kemi KRS2
9 Hot air oven Dolphin 75177
10 Mesh #16,40 Jayant ASL00
5. Lalitha: Formulation and Evaluation of Gastroretentive
IJPBA/Jul-Sep-2021/Vol 12/Issue 3 122
In practice, DM (mg) is released over a period of
time and is equal to the product of td (duration of
action per hour) and the zero-order rate k°r (mg/hr).
Therefore, the equation can expressed as
DTotal = DI + kotd
Ideally, the maintenance dose (DM) is released
after DI has produced a blood level equal to
the therapeutic drug level. However, due to
the limits of formulations, DM actually starts
to release at t = 0. Therefore, DTotal may be
reduced from the calculated amount to avoid “
tapping”
DTotal = DI – Kot + Kotd
The equation describes the total dose of the drug
needed, with “t” representing the time needed
to reach peak drug concentration after the initial
dose.
Pharmacokinetic Parameters of Lamivudine
Elimination half-life (t1/2) = 1.6 h
Time to reach peak plasma concentration
(TMax) = 1 h Conventional dose = 30 mg.
Calculations involved in the preparation of
lamivudine controlled release formulations
Conventional dose of lamivudine was found to be
20 mg. This was considered as initial dose (DI).
Calculation for elimination rate constant (KE)
KE = 0.693/t1/2
= 0.693/1.6
= 0.433/h
Calculation of zero-order release rate constant (Ko)
Desired release rate from maintenance dose
KO = DI × KE
= 30 × 0.433
= 12.9 mg/h.
Calculation of maintenance dose (DM)
DM = Ko [T – t1/2]
= 12.9 × (12-1.6)
= 12.9 × 10.4
= 134.16 mg
Calculation involved in correcting the initial loading
dose (DI*)
DI* = DI - [Ko × TMax]
= 30-[12.9 × 1] = 17.1 mg
Calculation of total dose
Total dose = DM + DI*
= 17.1 + 134.16 = 151.26 mg
Thedosewasroundedoffto150 mgforconvenience.
Construction of Theoretical Release Profile of
Lamivudine
Theoretical release profile of a drug is constructed
to check whether the formulations are releasing
the drug similar to the predicted profile. In case
of lamivudine, a loading dose of 30 mg may be
sufficient. To attain therapeutic level, drug input
rate of 12.9 mg/hr is required for maintenance of
therapeutic concentration of the drug.
A dose of 43 mg must be released with TMax, that
is, 1.6 h which was taken as 2 h. Subsequently, an
hourly dose of 10.7 mg should be released, finally
at the 12th
h, the total drug should be released
[Table 5].
Finally at the 12th
h, the total drug should be
released [Table 5] for 150 mg of lamivudine.
RESULTS AND DISCUSSION
In the present study, lamivudine was selected as
model drug in the design as GFDDS using various
lipoidal/fatty polymers. Lamivudine complies with
all the requirements that are suitable for a drug
candidate to be formulated as GFDDS, as it has
Table 5: Theoretical amount released and percent released
values of lamivudine
Time (h) Amount of lamivudine
released (mg)
Percent released
0 0 0
2 43 28.38
4 64.4 42.50
6 85.8 56.62
8 107.2 70.75
10 128.2 84.61
12 150 100
6. Lalitha: Formulation and Evaluation of Gastroretentive
IJPBA/Jul-Sep-2021/Vol 12/Issue 3 123
specific site of absorption in upper part of GIT.
Since the half-life of lamivudine is 1.6 h, multiple
doses are needed to maintain plasma concentration
for a good therapeutic response and improved
patient compliance.
A 150 mg dose of lamivudine was obtained from
sustained release calculations to maintain its
effective plasma drug concentrations for 12 h.
GFDDS of lamivudine was developed, to avoid
fluctuations in the plasma drug concentrations as
well as for increasing bioavailability of lamivudine.
The GFDDS retains in the stomach and thereby
improves the bioavailability of drugs that have an
absorption window in a particular region of the GI
tract than conventional oral controlled delivery
systems.
CONCLUSION
Oral drug administration is by far the most
preferable route for taking medications. However,
the therapeutic window of many drugs is limited
by their short circulating half-life and absorption
through a defined segment of the GIT. Such
pharmacokinetic limitations may lead in many
cases to frequent dosing of these medications to
achieve the required therapeutic effect and hence
poor patient compliance.
Majority of drugs are having site specific absorption
in the gastrointestinal tract and parameters such as
pH-dependent solubility, stability, and ionization
of the drug in different portions of the G.I. tract,
influence such absorption. GRT is one of the
important factors, which adversely affect the
absorption of drugs when administered simply by
an oral controlled delivery system.
GastroretentiveFDDSpossessestheabilityofbeing
retained in the stomach and help in optimizing the
oral controlled delivery of drugs having absorption
window by continuously releasing drug for
prolonged period of time thus ensuring optimal
biological absorption (BA).
Many attempts have been made in recent years
to provide a dosage form with longer GRT and
therefore a more efficient absorption. FDDS is
well proved and documented to be therapeutically
superior to conventional dosage system in number
of studies. Hence, the aim was “in accordance with
the therapeutic objective, to design and evaluate
hydrodynamically balanced non-effervescent
FDDS of lamivudine as controlled release
modules,” which prolongs the release rate of the
drug while extending the residence time of the drug
within the body environment and without causing
undeleterious effects to the subject. Lamivudine is
a potential anti-HIV agent, used for the long-term
treatment of HIV-1 infection. It is least absorbed
from lower part of the GIT and it has higher
absorption (specific site of absorption) in the
proximal region of the GI tract, that is, stomach
and it has short biological half-life (0.8–1.6 h)
following oral administration. All of these factors
favor the drug candidature feasible to formulate as
a gastroretentive system.
The present work was carried with an in house
experimental design to prepare multiunit granule
GFDDS employing successful cellulose polymers
and various efficient lipoidal/fatty polymers with a
motto to optimize best polymer among all of them
for formulation of hydrodynamically balanced
FDDS of lamivudine.
Lamivudine multiunit granule GFDDS with
controlled matrix cellulose and lipoidal polymers
was prepared by different granulation techniques
in the ratio of 1:1, 1:1.5, and 1:2.
Lamivudine multiunit formulations comprising
cellulose polymers were prepared by wet
granulation technique, whereas the lamivudine
multiunit formulations comprising lipoidal/fatty
polymers were prepared by melt granulation
technique.
All the multiunit granule formulations (F1–F21)
prepared were evaluated for drug content and all
the formulations had shown good results within
the official limits. They are even assessed for flow
characteristics such as bulk density, tapped density,
Carr’s index, and Hausner ratio. Formulations
with cellulose polymers had shown excellent
flow characters whereas formulations prepared
employing lipoidal polymers had shown a bit
inferior results to cellulose polymers as they are
prepared by melt granulation, but are passable.
The entire prepared multiunit granule GFFDS
was subjected to in vitro buoyancy studies that are
7. Lalitha: Formulation and Evaluation of Gastroretentive
IJPBA/Jul-Sep-2021/Vol 12/Issue 3 124
carried out in 0.1 N HCl. All the formulations F1–
F21 were tested for floating parameters like floating
lag time and floating duration time. Formulations
prepared with cellulose polymers in different
drug to polymer proportions (F1, F2, F8, F9, F15,
and F16) had shown buoyancy lag time which
might be the time taken for hydrogel formation,
whereas all the other formulations prepared with
lipoidal polymers in different drug to polymer
proportions had floated from 0 time. However,
in case of multiunit formulations prepared with
Compritol 888 ATO and Precirol ATO 5, 10–20%
and 60% of granules, respectively, had shrinked
to the bottom after 2 h. Other multiunit GFDDS
prepared with Lubritab, Cremophor, and Gelucire
43/01hadshownexcellentbuoyancycharacteristics
beyond 12 h of study.
The in vitro drug release studies of the entire
prepared multiunit GFDDS were studied separately
according to their proportions (1:1, 1:1.5, and 1:2)
using 0.1 N HCl as medium in USP XXIV paddle-
type dissolution apparatus.
Assessmentofdissolutionstudyresultsrevealedthat
formulationsF7(Lamivudine: Gelucire43/01–1:1),
F10 (Lamivudine: Compritol 888 ATO – 1:1.5),
and F19 (Lamivudine: Lubritab – 1:2) had retarded
the drug release in controlled manner up to 12 h.
Hence, these formulations were considered as
promising formulations. Even though formulation
F10 employing Compritol 888 ATO had retarded
the drug release up to 12 h, due to its poor
buoyancy characteristics, some extent of granules
had shrinked, which is not desirable for a GFDDS.
Formulation F19 prepared with Lubritab as
controlled floating polymer had retarded the drug
release up to 12 h successfully, but at a high drug
to polymer concentration of 1:2.
Formulation F7 prepared with low concentration of
Gelucire (1:1 proportion) had retarded the release
of lamivudine in a rate controlled manner up to
desired 12 h. Since the formulation F7 utilized less
polymer concentration, it was considered as the best
optimized formulation among other formulations.
The optimized formulation F7 was evaluated for
its floating ability and in vitro drug release studies
against single unit GFDDS prepared employing
same polymer, that is, Gelucire 43/01with drug-
to-polymer ratio of 1:3. By comparing the buoyant
characteristics and release characteristics among
F7 and single unit, single unit GFDDS had shown
excellent floating ability for more than 12 h, also
the drug release was found to be 81% for 12 h, by
an unknown mechanism of drug release.
The dissolution characteristics of optimized
multiunit formulation F7 are compared with that of
the pure drug and marketed formulation (STAVIR).
Pure drug had shown its high hydrophilic
characteristics by releasing 93% of drug in 0.5 h
itself, where as lamivudine marketed formulation
STAVIR had shown drug release of more than 97%
in 1 h.
To establish the mechanism of drug release, the
experimental data were fitted to five popular
exponential equations. The drug release of
lamivudine prepared from cellulose polymers
(by wet granulation) and from the lipoidal/fatty
polymers (by melt granulation) followed zero-
order kinetics which was clearly indicated by
higher “r” values of zero-order release when
compared to those of first-order release model.
The relative contributions of drug diffusion
and matrix erosion to drug release were further
confirmed by subjecting the dissolution data to
Higuchi model and erosion model. It was found that
all the formulations followed diffusion mechanism
as indicated by their higher “r” values.
By fitting all the data into Korsemeyer–Peppas
model (Power Law), all the formulations had
shown exponent “n” values above 1 indicating the
drug release strictly followed zero-order super case
II transport as the drug release mechanism.
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