This document describes the formulation and in vitro evaluation of oral disintegrating tablets containing the drug mirtazapine using the sublimation method. Sodium starch glycolate and croscarmellose sodium were used as disintegrants. The results showed no chemical interaction between mirtazapine and the excipients used. Formulation F9, containing camphor at 30 mg, showed the fastest drug release of 99.13% within 20 minutes and was selected as the optimized formulation. The drug release from F9 followed first-order kinetics. Overall, an oral disintegrating tablet of mirtazapine was successfully developed using the sublimation method that showed rapid disintegration and drug release.
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 oral route is the most favorable route for administration of drugs because of accurate dosage, low cost of therapy, self medication, non-invasive method, and ease of administration leading to a high level of patient compliance. Of the oral Dosage forms, solid dosage form is the preferred class of product as tablet represents a unit dosage form in which one dose of drug is placed accurately.
This document provides an overview of oral disintegrating tablets (ODTs), including their development, technologies used in their production, and evaluation methods. ODTs are solid dosage forms that disintegrate rapidly in the mouth, typically within 3 minutes, without water. They offer advantages over conventional tablets for patients who have difficulty swallowing. The document reviews various ODT production technologies such as freeze drying, spray drying, mass extrusion, and direct compression. It also discusses ideal properties, advantages, and limitations of ODTs.
Formulation Development and in Vitro Evaluation of Capecitabine Immediate Rel...ijtsrd
The aim of this study is to formulate and significantly improve the bioavailability and reduce the side effects of immediate release tablets Capecitabine. The precompression blends of Capecitabine were characterized with respect to angle of repose, bulk density, tapped density, Carr’s index and Hausner’s ratio. The precompression blend of all the batches indicates good to fair flowability and compressibility. Immediate release tablets were prepared with various disintegrants like PEG 6000, Croscarmellose sodium and Sodium starch glycolate at different concentration ratios and were compressed into tablets. The formulated tablets were evaluated for various quality control parameters. The tablets were passed all tests. Among all the formulations F7 formulation containing, drug and Croscarmellose sodium showed good result that is 98.12 in 45 min. Hence from the dissolution data it was evident that F7 formulation is the better formulation. Dr. G. Jagadish | Dr. Vibhor Kumar Jain | Rama Shukla "Formulation Development and in Vitro Evaluation of Capecitabine Immediate Release Tablets" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-2 , April 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd55058.pdf Paper URL: https://www.ijtsrd.com.com/pharmacy/pharmaceutics/55058/formulation-development-and-in-vitro-evaluation-of-capecitabine-immediate-release-tablets/dr-g-jagadish
Mouth dissolving tablets- A unique dosage form curtailed for special purpose:...IOSR Journals
The concept of mouth dissolving tablets known as MDTs has emerged with an objective to improve patient’s compliance. Methods to improve patient’s compliance have always attracted scientists towards the development of fancy oral drug delivery systems. Among them, mouth dissolving drug delivery systems (MDDDS) have obtained an important position in the market by overcoming previously encountered administration problems and contributing to extension of patent life. These dosage forms rapidly disintegrate in contact with saliva even within <60 seconds, an attribute that makes them highly attractive for paediatric, geriatric, bedridden patients and for active patients who are busy and in travelling may not have access to water. This special dosage form has some prerequisite criteria for formulation and this also involves the use of special techniques for large scale industrial production. The aim of this article is to review the advantages and disadvantages of MDTs, common excipients used in the formulation especially highlighting the use of superdisintegrating agents and taste masking agents in formulation and finally the popular methods used to produce large scale tablets for commercial purpose.
ABSTRACT The purpose of this study was to prepare and evaluate immediate release itraconazole pellets and comprehensive studies of the same. The itraconazole pellets is prepared using fluid bed processer with different concentration of HPMC (Hydroxy Propyl Methyl Cellulose). The physicochemical compatibility of the drug and the excipient studied by differential scanning calorimetry. The prepared pellets were physically evaluated with size, shape, bulk density, tapped density, compressibility index, hausners ratio, angle of repose, sieve analysis, surface roughness, density, moisture content, assay and drug release etc. The in vitro drug release profile from pellets shows that all the formulation release more than 75% drug within 90min. Optimized formulations were found to have HPMC concentration 2-5% of total weight of pellets to maximize high-quality surface, desired release, and size distribution within the range. These results indicate that pellets containing 10 % HPMC of total weight of pellets give better quality of itraconazole pellets for immediate release. Key Words: Itraconazole, Hydroxyl propyl methyl cellulose and Immediate release.
Formulation and Evaluation of Floating Tablet of Metoprolol Succinateijtsrd
The aim of the present work is Formulation and Evaluation of Floating Tablet of Metoprolol Succinate. Metoprolol Succinate is a BCS class I drug used in the treatment of Angina pectoric, Heart attack, Hypertension and has short half life 3 7hours. In the present study it was planned to prepare sustained release floating tablets of Metoprolol succinate by using HPMC E5 and Gum Karaya excipients. The procured sample of drug was authenticated by pre formulation study like melting point, IR spectra, UV analysis were done. Results of pre formulation studies show that Metoprolol Succinate was pure and complies with standard. Prior to compression, the powder blend were evaluated for angle of repose, bulk density, tapped density, compressibility index, Hausners ratio. Results of pre formulation studies show that Metoprolol Succinate was pure and complies with standard. Formulations were evaluated for various evaluation parameters like hardness, thickness, weight variation, friability, drug content, floating lag time, floating time, swelling index and in vitro drug release. From the results of evaluation parameters it was observed that formulation F6 shows best results for floating lag time 4min floating time up to 12 hours and consistent drug release 96.15 as compared to other formulations. So formulation F6 was finalized as a optimized formulation for further study. On the basic of above finding it was concluded that sustained release floating drug delivery system was successfully achieved. Neeta. V. Jadhav | Prof. Mr. Prashant Khade | Dr. Ashok Bhosale "Formulation and Evaluation of Floating Tablet of Metoprolol Succinate" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-5 , August 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50409.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/50409/formulation-and-evaluation-of-floating-tablet-of-metoprolol-succinate/neeta-v-jadhav
Preparation and Evaluation of Immediate Release Tabletsijtsrd
Background Tablet is that the preferred among all dosage forms existing today thanks to its convenience of self administration, compactness and simple manufacturing however in many cases immediate onset of action is required than conventional therapy. There are novel kinds of dosage form.The scenario of pharmaceutical drug delivery are expeditiously challenging, but conventional pharmaceutical dosage forms are still dominating. Immediate release dosage forms are those wherein =85 of labeled amount dissolves within 30 min. Superd is integrants are accustomed improve the efficacy of solid dosage forms. orms that act very quickly after administration To overcome these drawbacks, immediate release pharmaceutical dosage form has emerged as alternative oral dosage forms. There are novel forms of dosage forms that act very quickly after administration. the fundamental approach utilized in development tablets is that the use of superdisintegrants like Cross linked carboxymelhylcellulose Croscarmeliose , Sodium starch glycolate Primogel, Explotab , Polyvinylpyrrolidone Polyplasdone etc. which give instantaneous disintegration of tablet after administration. Immediate release liquid dosage forms and parenteral dosage form have also been introduced for treating patients. Dosage form can be suspensions with typical dispersion agents like hydroxypropylmethylcellulose, dioctylsulfosuccinate etc. a replacement dosage form allows a manufacturer to increasemarket exclusivity, while offering its patient population a more convenient dosage form or dosing regimen.These superdisintegrants provide instantaneous disintegration of the tablet after administration within the stomach. This article provide an exhaustive account illustrating the significances of superdisintegrant within the immediate release of tablets and therefore the mechanism of disintegration together with various conventional techniques and novel granulation technology wont to prepare immediate release tablets. ach. Thus, decreasing the disintegration time which successively enhances drug dissolution rate. Results From this review, we can ready to develop and evaluate immediate release tablets.also we must always understand role of immediate release tablets.Conclusion Most of the patients need quick therapeutic action of the drug, leading to poor compliance with conventional drug therapy which results in reduced overall therapy effectiveness. For this we will conclude that immediate release tablets are simpler. because immediate release tablet shows quick effect. Sakshi Ghuge | Prof. Smita More "Preparation and Evaluation of Immediate Release Tablets" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-1 , December 2020, URL: https://www.ijtsrd.com/papers/ijtsrd35867.pdf Paper URL : https://www.ijtsrd.com/pharmacy/pharmaceutics/35867/preparation-and-evaluation-of-immediate-release-tablets/sakshi-ghuge
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 oral route is the most favorable route for administration of drugs because of accurate dosage, low cost of therapy, self medication, non-invasive method, and ease of administration leading to a high level of patient compliance. Of the oral Dosage forms, solid dosage form is the preferred class of product as tablet represents a unit dosage form in which one dose of drug is placed accurately.
This document provides an overview of oral disintegrating tablets (ODTs), including their development, technologies used in their production, and evaluation methods. ODTs are solid dosage forms that disintegrate rapidly in the mouth, typically within 3 minutes, without water. They offer advantages over conventional tablets for patients who have difficulty swallowing. The document reviews various ODT production technologies such as freeze drying, spray drying, mass extrusion, and direct compression. It also discusses ideal properties, advantages, and limitations of ODTs.
Formulation Development and in Vitro Evaluation of Capecitabine Immediate Rel...ijtsrd
The aim of this study is to formulate and significantly improve the bioavailability and reduce the side effects of immediate release tablets Capecitabine. The precompression blends of Capecitabine were characterized with respect to angle of repose, bulk density, tapped density, Carr’s index and Hausner’s ratio. The precompression blend of all the batches indicates good to fair flowability and compressibility. Immediate release tablets were prepared with various disintegrants like PEG 6000, Croscarmellose sodium and Sodium starch glycolate at different concentration ratios and were compressed into tablets. The formulated tablets were evaluated for various quality control parameters. The tablets were passed all tests. Among all the formulations F7 formulation containing, drug and Croscarmellose sodium showed good result that is 98.12 in 45 min. Hence from the dissolution data it was evident that F7 formulation is the better formulation. Dr. G. Jagadish | Dr. Vibhor Kumar Jain | Rama Shukla "Formulation Development and in Vitro Evaluation of Capecitabine Immediate Release Tablets" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-2 , April 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd55058.pdf Paper URL: https://www.ijtsrd.com.com/pharmacy/pharmaceutics/55058/formulation-development-and-in-vitro-evaluation-of-capecitabine-immediate-release-tablets/dr-g-jagadish
Mouth dissolving tablets- A unique dosage form curtailed for special purpose:...IOSR Journals
The concept of mouth dissolving tablets known as MDTs has emerged with an objective to improve patient’s compliance. Methods to improve patient’s compliance have always attracted scientists towards the development of fancy oral drug delivery systems. Among them, mouth dissolving drug delivery systems (MDDDS) have obtained an important position in the market by overcoming previously encountered administration problems and contributing to extension of patent life. These dosage forms rapidly disintegrate in contact with saliva even within <60 seconds, an attribute that makes them highly attractive for paediatric, geriatric, bedridden patients and for active patients who are busy and in travelling may not have access to water. This special dosage form has some prerequisite criteria for formulation and this also involves the use of special techniques for large scale industrial production. The aim of this article is to review the advantages and disadvantages of MDTs, common excipients used in the formulation especially highlighting the use of superdisintegrating agents and taste masking agents in formulation and finally the popular methods used to produce large scale tablets for commercial purpose.
ABSTRACT The purpose of this study was to prepare and evaluate immediate release itraconazole pellets and comprehensive studies of the same. The itraconazole pellets is prepared using fluid bed processer with different concentration of HPMC (Hydroxy Propyl Methyl Cellulose). The physicochemical compatibility of the drug and the excipient studied by differential scanning calorimetry. The prepared pellets were physically evaluated with size, shape, bulk density, tapped density, compressibility index, hausners ratio, angle of repose, sieve analysis, surface roughness, density, moisture content, assay and drug release etc. The in vitro drug release profile from pellets shows that all the formulation release more than 75% drug within 90min. Optimized formulations were found to have HPMC concentration 2-5% of total weight of pellets to maximize high-quality surface, desired release, and size distribution within the range. These results indicate that pellets containing 10 % HPMC of total weight of pellets give better quality of itraconazole pellets for immediate release. Key Words: Itraconazole, Hydroxyl propyl methyl cellulose and Immediate release.
Formulation and Evaluation of Floating Tablet of Metoprolol Succinateijtsrd
The aim of the present work is Formulation and Evaluation of Floating Tablet of Metoprolol Succinate. Metoprolol Succinate is a BCS class I drug used in the treatment of Angina pectoric, Heart attack, Hypertension and has short half life 3 7hours. In the present study it was planned to prepare sustained release floating tablets of Metoprolol succinate by using HPMC E5 and Gum Karaya excipients. The procured sample of drug was authenticated by pre formulation study like melting point, IR spectra, UV analysis were done. Results of pre formulation studies show that Metoprolol Succinate was pure and complies with standard. Prior to compression, the powder blend were evaluated for angle of repose, bulk density, tapped density, compressibility index, Hausners ratio. Results of pre formulation studies show that Metoprolol Succinate was pure and complies with standard. Formulations were evaluated for various evaluation parameters like hardness, thickness, weight variation, friability, drug content, floating lag time, floating time, swelling index and in vitro drug release. From the results of evaluation parameters it was observed that formulation F6 shows best results for floating lag time 4min floating time up to 12 hours and consistent drug release 96.15 as compared to other formulations. So formulation F6 was finalized as a optimized formulation for further study. On the basic of above finding it was concluded that sustained release floating drug delivery system was successfully achieved. Neeta. V. Jadhav | Prof. Mr. Prashant Khade | Dr. Ashok Bhosale "Formulation and Evaluation of Floating Tablet of Metoprolol Succinate" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-5 , August 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50409.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/50409/formulation-and-evaluation-of-floating-tablet-of-metoprolol-succinate/neeta-v-jadhav
Preparation and Evaluation of Immediate Release Tabletsijtsrd
Background Tablet is that the preferred among all dosage forms existing today thanks to its convenience of self administration, compactness and simple manufacturing however in many cases immediate onset of action is required than conventional therapy. There are novel kinds of dosage form.The scenario of pharmaceutical drug delivery are expeditiously challenging, but conventional pharmaceutical dosage forms are still dominating. Immediate release dosage forms are those wherein =85 of labeled amount dissolves within 30 min. Superd is integrants are accustomed improve the efficacy of solid dosage forms. orms that act very quickly after administration To overcome these drawbacks, immediate release pharmaceutical dosage form has emerged as alternative oral dosage forms. There are novel forms of dosage forms that act very quickly after administration. the fundamental approach utilized in development tablets is that the use of superdisintegrants like Cross linked carboxymelhylcellulose Croscarmeliose , Sodium starch glycolate Primogel, Explotab , Polyvinylpyrrolidone Polyplasdone etc. which give instantaneous disintegration of tablet after administration. Immediate release liquid dosage forms and parenteral dosage form have also been introduced for treating patients. Dosage form can be suspensions with typical dispersion agents like hydroxypropylmethylcellulose, dioctylsulfosuccinate etc. a replacement dosage form allows a manufacturer to increasemarket exclusivity, while offering its patient population a more convenient dosage form or dosing regimen.These superdisintegrants provide instantaneous disintegration of the tablet after administration within the stomach. This article provide an exhaustive account illustrating the significances of superdisintegrant within the immediate release of tablets and therefore the mechanism of disintegration together with various conventional techniques and novel granulation technology wont to prepare immediate release tablets. ach. Thus, decreasing the disintegration time which successively enhances drug dissolution rate. Results From this review, we can ready to develop and evaluate immediate release tablets.also we must always understand role of immediate release tablets.Conclusion Most of the patients need quick therapeutic action of the drug, leading to poor compliance with conventional drug therapy which results in reduced overall therapy effectiveness. For this we will conclude that immediate release tablets are simpler. because immediate release tablet shows quick effect. Sakshi Ghuge | Prof. Smita More "Preparation and Evaluation of Immediate Release Tablets" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-1 , December 2020, URL: https://www.ijtsrd.com/papers/ijtsrd35867.pdf Paper URL : https://www.ijtsrd.com/pharmacy/pharmaceutics/35867/preparation-and-evaluation-of-immediate-release-tablets/sakshi-ghuge
This document summarizes the formulation and evaluation of fast dissolving tablet dosages of felodipine. It discusses the drug profile, aim/objectives of developing fast dissolving tablets, materials/equipment used, preparation of formulations using different superdisintegrants (crospovidone, crosscarmellose sodium, sodium starch glycolate), and evaluation of tablet properties (thickness, hardness, friability) and performance (disintegration time, dissolution). 9 formulations were developed and evaluated, with F3 showing the fastest disintegration time of 116 seconds and highest drug release of 90.58% within 30 minutes. The study demonstrated the potential of using superdisintegrants to develop fast dissolving felodipine tablets for improved patient compliance and
This document provides a review of oral dispersible tablets. It begins with an introduction that defines oral dispersible tablets as solid dosages that disintegrate rapidly, usually within seconds, when placed on the tongue. It describes the advantages of these tablets for patients who have difficulty swallowing conventional tablets. The document then reviews various technologies used to manufacture oral dispersible tablets, including lyophilization, molding, cotton candy process, and spray drying. It also discusses commonly used excipients and superdisintegrants and their mechanisms of action in rapidly disintegrating tablets.
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.
ABSTRACT
Overactive bladder (OAB) is a prevalent condition which has an adverse effect on quality of life. The presence
of urgency incontinence confers significant morbidity above and beyond that of OAB sufferers who are
continent. The primary treatment for OAB and urgency incontinence is a combination of behavioral measures
and antimuscarinic drug therapy. The ideal antimuscarinic agent should effectively relieve the symptoms of
OAB, with the minimum of side effects; it should be available as a once-daily sustained release formulation
and in dosage strength that allows easy dose titration for the majority of sufferers. Solifenacin succinate was
launched in 2005 and has been shown in both short and long term clinical trials to fulfill these requirements.
Solifenacin is a competitive M3 receptor antagonist with a long half-life (45-68 hours). It is available in two
dosage strengths namely a 5 or 10 mg once-daily tablet. The efficacy and tolerability of solifenacin for the
treatment of all symptoms of OAB has been evaluated in a number of large, placebo controlled, randomized
trials. Long-term safety, efficacy, tolerability and persistence with treatment have been established in an open
label 40 week continuation study.
KEYWORDS
Solifenacin, Urinary incontinence, Overactive bladder and Wet granulation method.
ABSTRACT
The aim of the present research work was to enhance the solubility of
Carvedilol by solid dispersion method and to formulate a mouth
dissolving tablet. Drugs are more frequently taken by oral
administration. The solubility of Carvedilol enhanced with different
ratios of PVP by the solvent evaporation method .In-vitro release
profile of solid dispersion obtained in SGF without enzymes and Ph
6.8 phosphate buffer indicate that 100% drug release found within 20
min. These solid dispersion were directly compressed into tablets using
Crospovidone, sodium starch glycol ate, croscarmellose sodium and
polyacrylic potassium in different concentrations as a super
disintegrants. The prepared tablets containing the solid dispersion of
Carvedilol having sufficient strength of 2.5-4 kg/cm2. The
disintegrated in the oral cavity with in 21 sec. contain Crospovidone
(5%) as super disintegrant.
KEYWORDS: Carvedilol, PVP, Super Disintegrants, Mouth Dissolving Tablet.
Microbiology plays an important role in ensuring the quality of oral liquid pharmaceutical products. Contamination of excipients used in oral liquids can have serious health consequences. A quality control microbiology laboratory tests starting materials, manufacturing processes, and final products to ensure safety and efficacy. Acceptance criteria for non-sterile oral dosage forms specify limits for total aerobic microbial count and total yeast and mold count to minimize health risks from microbes.
The document describes the formulation and evaluation of oral thin films containing the drug pitavastatin. Various oral thin film formulations were prepared using solvent casting method with polymers like povidone and HPMC K4M. The solubility of pitavastatin was studied in different buffers and 0.1N HCl showed highest solubility. Compatibility studies using FTIR showed no interactions between drug and excipients. The formulated films were evaluated for weight uniformity, thickness, folding endurance, drug content uniformity and in vitro drug release. The stable formulation F8 released 99% of drug within 5 minutes and was selected for further stability studies. The results suggested formulation F8 was stable for 3 months. Bioavailability studies are needed before commercialization
This document discusses the process of manufacturing tablets. It begins by providing an introduction and definition of tablets. It then discusses the advantages and disadvantages of tablets. The document outlines the different types of tablets and describes the main manufacturing processes of wet granulation, dry granulation, and direct compression. It provides details on each process and discusses their advantages and limitations. The document is a guide on the production of tablets from start to finish.
This document provides an overview of orodispersible tablets. It discusses their history, formulation strategies, evaluation parameters and benefits over conventional tablets. Orodispersible tablets are designed to dissolve rapidly in the mouth without water. They were developed to help patients like children, elderly and those with swallowing difficulties. The key ingredients are superdisintegrants which cause the tablet to break apart quickly. Evaluation tests include hardness, friability, wetting time and in vitro dissolution studies. Orodispersible tablets offer ease of administration, accurate dosing and enhanced bioavailability compared to other dosage forms.
This document describes the formulation and evaluation of oral thin films containing the drug pitavastatin. Various oral thin film formulations were prepared using solvent casting method with polymers like PVP, HPMC and gelatin. The solubility studies showed pitavastatin has highest solubility in 0.1N HCl. Compatibility studies using FTIR showed no interactions between drug and excipients. The formulated films were evaluated for weight uniformity, thickness, folding endurance, drug content uniformity and in vitro drug release. The stable F8 formulation from 3 months stability studies will be subjected to bioavailability studies and commercialized if requirements are met.
This document summarizes a seminar presentation on mouth dissolving films as an effective oral disintegrating drug delivery system. Key points include: Mouth dissolving films were developed as an alternative to tablets and capsules for patients who have difficulty swallowing. The films are thin, elegant, and rapidly disintegrate in the oral cavity upon contact with saliva. Common methods for preparing mouth dissolving films include solvent casting, semi-solid casting, hot extrusion, and solid dispersion extrusion. Films are evaluated based on parameters like thickness, disintegration time, and drug dissolution. Applications include use for pediatric/geriatric patients, topical drug delivery, and as diagnostic devices or for gastroretentive drug delivery.
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).
Recently, fast dissolving oral films have started gaining fame and acceptance as new drug delivery systems, which aim to enhance safety and efficacy of a drug molecule to achieve better patient compliance. It is a robust form a drug delivery system where the film is placed on the top or the floor of the tongue. When put on the tongue, this film dissolves instantaneously, releasing the drug which dissolves in the saliva. Buccal drug delivery has lately become an important route of drug administration. But many of the patients paediatrics and geriatrics are unwilling to take solid preparations due to fear of choking. This has made the pharmaceutical industry look for alternatives routes of drug delivery like film drug delivery. Fast dissolving oral drug delivery system have started gaining popularity and acceptance as new drug delivery system, because they are easy to administer, better patient compliance, rapid drug absorption, and sudden onset of drug action with instant bioavailability is possible. This review reflects information regarding formulation ingredient, technologies and evaluation test employed in the preparation of fast dissolving oral films. Mr. Vijay P. Ingle | Prof. Sharad D. Tayade | Dr. Shirish P. Jain "A Review on: Fast Dissolving Oral Film" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-5 , August 2021, URL: https://www.ijtsrd.com/papers/ijtsrd43836.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/43836/a-review-on-fast-dissolving-oral-film/mr-vijay-p-ingle
Formulation, Evaluation and Optimization of Fast Disintegrating Nifedipine 20...Makrani Shaharukh
Tablet among the all dosage form is the common one and in the Pharmacy it is the mother of Pharmacy. Generally tablet are accepted in all category of patient. In children Dispersible form and in female for virginal infection virginal form are the preferred. The most common preferred route is oral rout of administration. In ancient Ayurveda, Unani, Greek, Egyptian remedies drug in the form of Churna, Bhasma, Gutika, Araka, are administered though oral rout. Pills which are coated by natural resinous material are administered in the form of tablet through oral rout. Today oro-dispersible tablet from novel drug delivery system gain importance from patient. Which is administer to the patient to control the various immediate action viz. attack of angina or hypertension in cardiac problems. Orodispersible tablet gets dispersed in oral cavity in absence of water and release fast drug which result fast pharmacological action. In the market drug from Analgesic, Antipyretic, Antihypertensive and many more are available in the form of the orodispersible tablet. Various manufacture are formulated this formulation by various method. The most importance thing in this formulation are masking of taste of drugs. Generally oro-dispersible tablet are prepared by direct compression method. Dry granulation, wet granulation, Spry drying is the various methods for preparation of oro-dispersible tablet. Oro-dispersible tablet generally contains filler, glidant, antiadherent super disintegrate, Flavoring agent sweetener and resins. Evaluation parameter includes hardness, friability, wetting time, moisture uptake, disintegration test, and dissolution test. Wetting time, Disintegration time, and Dissolution test is directly proportional to the hydrophobic ingredient added for lubrication, anti-adherent, Glidant action. These hydrophobic ingredient are Magnesium Stearate. To oppose the action of magnesium stearate, hydrophilic additives are incorporated viz Sodium lauryl sulphate. From Marketing point of view special Marketing Executive team required to promote the new technique , new formulation with demonstration to the Cardiac Surgeon, Pediatrics, Orthopedics, Gynecologists, Ophthalmologists, Urologist. After demonstration that how to use the Orodispersible tablet these marketing team personally serve to the new admitted patients.
The main objective of the present research work is to formulate the Clopidogrel Fast Dissolving tablets. Clopidogrel, an antiplatelet drug, belongs to BCS Class-II and used to control Heart attack, Hypertension by inhibiting Platelet activation and aggregation .The Fast Dissolving tablets of Clopidogrel were prepared employing different concentrations of Crospovidone and Croscarmellose sodium in different combinations as a Superdisintegrant 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, t50%, t90% were selected as dependent variables. Totally nine formulations were designed and evaluated for hardness, friability, thickness, Assay, Wetting time, Disintegration time, and 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 into different Kinetic models, the statistical parameters like intercept (a), slope (b) and regression coefficient (r) were calculated. Polynomial equations were developed for Wetting time, Disintegration time, t50%, t90%. Validity of developed polynomial equations was verified by designing 2 check point formulations (C1, C2). According to SUPAC guidelines, the formulation (F5) containing combination of 15% Crospovidone and 15% Croscarmellose, is the most similar formulation (similarity factor f2=91.3936, dissimilarity factor f1= 1.203& No significant difference, t= -0.00062) to marketed product (PLAVIX-75). The selected formulation (F1) follows First order, Higuchi’s kinetics, mechanism of drug release found to be Fickian Diffusion (n= 0.226).
Review on Formulation Approaches and Evaluation Parameters of Mouth Dissolvin...ijtsrd
Since the past decade, oral administration has received substantially more attention for the treatment or management of disorders. Mouth dissolving tablets MDTs , a novel idea in oral delivery, are now widely used. Mouth dissolving tablets are solid dosage forms that dissolve and release the active ingredient when placed in the mouth for a short period of time without the use of water. Geriatric, paediatric, and bedridden patients are particularly affected by it since they have swallowing issues, like those with dysphasia. This article discusses the various excipients evaluation tests, marketed formulations, and drugs used in his research area, along with the many formulation aspects and technologies developed for MDTs. The advancement in this field allows the development of an affordable and improved method of disease management with avoidance of numerous issues associated to the other delivery systems. Kamlesh R. Deshmane | Dr. V. U. Barge | Pratiksha B. Avhad "Review on Formulation Approaches and Evaluation Parameters of Mouth Dissolving Tablet" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-2 , April 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd55178.pdf Paper URL: https://www.ijtsrd.com.com/pharmacy/pharmaceutics/55178/review-on-formulation-approaches-and-evaluation-parameters-of-mouth-dissolving-tablet/kamlesh-r-deshmane
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.
ABSTRACT
The main objective of present research work is to formulate the floating tablets of Carvedilol Phosphate using 32 factorial design. Carvedilol Phosphate, non-selective α1-β1-blocking agent belongs to BCS Class-II and Indicated for treatment of Hypertension/moderate Heart Failure. The Floating tablets of Carvedilol Phosphate were prepared employing different concentrations of HPMCK100M and Sodium bicarbonate in different combinations by Direct Compression technique using 32 factorial design. The concentration of HPMCK100M and Sodium bicarbonate 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 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 (F8) containing combination of 25% HPMCK100M and 3.75% Sodium bicarbonate, is the most similar formulation (similarity factor f2=88.801, dissimilarity factor f1= 2.250 & No significant difference, t= 0.095) to marketed product (CARDIVAS). The selected formulation (F8) follows Higuchi’s kinetics, and the mechanism
This document discusses oral dissolving films (ODFs), which are thin films that dissolve quickly in the mouth. ODFs offer benefits like rapid onset of action, avoidance of first-pass metabolism, improved patient compliance, and ease of administration without water. The document reviews the process of ODF production, current products on the market, potential drugs that could be delivered via ODF, and a study developing a pantoprazole ODF using hydroxypropyl methylcellulose polymers. The study found that the lower viscosity HPMC LV polymer was more effective for rapid film disintegration and drug dissolution compared to the higher viscosity HPMC E 15 polymer.
This document summarizes the formulation and evaluation of fast dissolving tablet dosages of felodipine. It discusses the drug profile, aim/objectives of developing fast dissolving tablets, materials/equipment used, preparation of formulations using different superdisintegrants (crospovidone, crosscarmellose sodium, sodium starch glycolate), and evaluation of tablet properties (thickness, hardness, friability) and performance (disintegration time, dissolution). 9 formulations were developed and evaluated, with F3 showing the fastest disintegration time of 116 seconds and highest drug release of 90.58% within 30 minutes. The study demonstrated the potential of using superdisintegrants to develop fast dissolving felodipine tablets for improved patient compliance and
This document provides a review of oral dispersible tablets. It begins with an introduction that defines oral dispersible tablets as solid dosages that disintegrate rapidly, usually within seconds, when placed on the tongue. It describes the advantages of these tablets for patients who have difficulty swallowing conventional tablets. The document then reviews various technologies used to manufacture oral dispersible tablets, including lyophilization, molding, cotton candy process, and spray drying. It also discusses commonly used excipients and superdisintegrants and their mechanisms of action in rapidly disintegrating tablets.
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.
ABSTRACT
Overactive bladder (OAB) is a prevalent condition which has an adverse effect on quality of life. The presence
of urgency incontinence confers significant morbidity above and beyond that of OAB sufferers who are
continent. The primary treatment for OAB and urgency incontinence is a combination of behavioral measures
and antimuscarinic drug therapy. The ideal antimuscarinic agent should effectively relieve the symptoms of
OAB, with the minimum of side effects; it should be available as a once-daily sustained release formulation
and in dosage strength that allows easy dose titration for the majority of sufferers. Solifenacin succinate was
launched in 2005 and has been shown in both short and long term clinical trials to fulfill these requirements.
Solifenacin is a competitive M3 receptor antagonist with a long half-life (45-68 hours). It is available in two
dosage strengths namely a 5 or 10 mg once-daily tablet. The efficacy and tolerability of solifenacin for the
treatment of all symptoms of OAB has been evaluated in a number of large, placebo controlled, randomized
trials. Long-term safety, efficacy, tolerability and persistence with treatment have been established in an open
label 40 week continuation study.
KEYWORDS
Solifenacin, Urinary incontinence, Overactive bladder and Wet granulation method.
ABSTRACT
The aim of the present research work was to enhance the solubility of
Carvedilol by solid dispersion method and to formulate a mouth
dissolving tablet. Drugs are more frequently taken by oral
administration. The solubility of Carvedilol enhanced with different
ratios of PVP by the solvent evaporation method .In-vitro release
profile of solid dispersion obtained in SGF without enzymes and Ph
6.8 phosphate buffer indicate that 100% drug release found within 20
min. These solid dispersion were directly compressed into tablets using
Crospovidone, sodium starch glycol ate, croscarmellose sodium and
polyacrylic potassium in different concentrations as a super
disintegrants. The prepared tablets containing the solid dispersion of
Carvedilol having sufficient strength of 2.5-4 kg/cm2. The
disintegrated in the oral cavity with in 21 sec. contain Crospovidone
(5%) as super disintegrant.
KEYWORDS: Carvedilol, PVP, Super Disintegrants, Mouth Dissolving Tablet.
Microbiology plays an important role in ensuring the quality of oral liquid pharmaceutical products. Contamination of excipients used in oral liquids can have serious health consequences. A quality control microbiology laboratory tests starting materials, manufacturing processes, and final products to ensure safety and efficacy. Acceptance criteria for non-sterile oral dosage forms specify limits for total aerobic microbial count and total yeast and mold count to minimize health risks from microbes.
The document describes the formulation and evaluation of oral thin films containing the drug pitavastatin. Various oral thin film formulations were prepared using solvent casting method with polymers like povidone and HPMC K4M. The solubility of pitavastatin was studied in different buffers and 0.1N HCl showed highest solubility. Compatibility studies using FTIR showed no interactions between drug and excipients. The formulated films were evaluated for weight uniformity, thickness, folding endurance, drug content uniformity and in vitro drug release. The stable formulation F8 released 99% of drug within 5 minutes and was selected for further stability studies. The results suggested formulation F8 was stable for 3 months. Bioavailability studies are needed before commercialization
This document discusses the process of manufacturing tablets. It begins by providing an introduction and definition of tablets. It then discusses the advantages and disadvantages of tablets. The document outlines the different types of tablets and describes the main manufacturing processes of wet granulation, dry granulation, and direct compression. It provides details on each process and discusses their advantages and limitations. The document is a guide on the production of tablets from start to finish.
This document provides an overview of orodispersible tablets. It discusses their history, formulation strategies, evaluation parameters and benefits over conventional tablets. Orodispersible tablets are designed to dissolve rapidly in the mouth without water. They were developed to help patients like children, elderly and those with swallowing difficulties. The key ingredients are superdisintegrants which cause the tablet to break apart quickly. Evaluation tests include hardness, friability, wetting time and in vitro dissolution studies. Orodispersible tablets offer ease of administration, accurate dosing and enhanced bioavailability compared to other dosage forms.
This document describes the formulation and evaluation of oral thin films containing the drug pitavastatin. Various oral thin film formulations were prepared using solvent casting method with polymers like PVP, HPMC and gelatin. The solubility studies showed pitavastatin has highest solubility in 0.1N HCl. Compatibility studies using FTIR showed no interactions between drug and excipients. The formulated films were evaluated for weight uniformity, thickness, folding endurance, drug content uniformity and in vitro drug release. The stable F8 formulation from 3 months stability studies will be subjected to bioavailability studies and commercialized if requirements are met.
This document summarizes a seminar presentation on mouth dissolving films as an effective oral disintegrating drug delivery system. Key points include: Mouth dissolving films were developed as an alternative to tablets and capsules for patients who have difficulty swallowing. The films are thin, elegant, and rapidly disintegrate in the oral cavity upon contact with saliva. Common methods for preparing mouth dissolving films include solvent casting, semi-solid casting, hot extrusion, and solid dispersion extrusion. Films are evaluated based on parameters like thickness, disintegration time, and drug dissolution. Applications include use for pediatric/geriatric patients, topical drug delivery, and as diagnostic devices or for gastroretentive drug delivery.
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).
Recently, fast dissolving oral films have started gaining fame and acceptance as new drug delivery systems, which aim to enhance safety and efficacy of a drug molecule to achieve better patient compliance. It is a robust form a drug delivery system where the film is placed on the top or the floor of the tongue. When put on the tongue, this film dissolves instantaneously, releasing the drug which dissolves in the saliva. Buccal drug delivery has lately become an important route of drug administration. But many of the patients paediatrics and geriatrics are unwilling to take solid preparations due to fear of choking. This has made the pharmaceutical industry look for alternatives routes of drug delivery like film drug delivery. Fast dissolving oral drug delivery system have started gaining popularity and acceptance as new drug delivery system, because they are easy to administer, better patient compliance, rapid drug absorption, and sudden onset of drug action with instant bioavailability is possible. This review reflects information regarding formulation ingredient, technologies and evaluation test employed in the preparation of fast dissolving oral films. Mr. Vijay P. Ingle | Prof. Sharad D. Tayade | Dr. Shirish P. Jain "A Review on: Fast Dissolving Oral Film" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-5 , August 2021, URL: https://www.ijtsrd.com/papers/ijtsrd43836.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/43836/a-review-on-fast-dissolving-oral-film/mr-vijay-p-ingle
Formulation, Evaluation and Optimization of Fast Disintegrating Nifedipine 20...Makrani Shaharukh
Tablet among the all dosage form is the common one and in the Pharmacy it is the mother of Pharmacy. Generally tablet are accepted in all category of patient. In children Dispersible form and in female for virginal infection virginal form are the preferred. The most common preferred route is oral rout of administration. In ancient Ayurveda, Unani, Greek, Egyptian remedies drug in the form of Churna, Bhasma, Gutika, Araka, are administered though oral rout. Pills which are coated by natural resinous material are administered in the form of tablet through oral rout. Today oro-dispersible tablet from novel drug delivery system gain importance from patient. Which is administer to the patient to control the various immediate action viz. attack of angina or hypertension in cardiac problems. Orodispersible tablet gets dispersed in oral cavity in absence of water and release fast drug which result fast pharmacological action. In the market drug from Analgesic, Antipyretic, Antihypertensive and many more are available in the form of the orodispersible tablet. Various manufacture are formulated this formulation by various method. The most importance thing in this formulation are masking of taste of drugs. Generally oro-dispersible tablet are prepared by direct compression method. Dry granulation, wet granulation, Spry drying is the various methods for preparation of oro-dispersible tablet. Oro-dispersible tablet generally contains filler, glidant, antiadherent super disintegrate, Flavoring agent sweetener and resins. Evaluation parameter includes hardness, friability, wetting time, moisture uptake, disintegration test, and dissolution test. Wetting time, Disintegration time, and Dissolution test is directly proportional to the hydrophobic ingredient added for lubrication, anti-adherent, Glidant action. These hydrophobic ingredient are Magnesium Stearate. To oppose the action of magnesium stearate, hydrophilic additives are incorporated viz Sodium lauryl sulphate. From Marketing point of view special Marketing Executive team required to promote the new technique , new formulation with demonstration to the Cardiac Surgeon, Pediatrics, Orthopedics, Gynecologists, Ophthalmologists, Urologist. After demonstration that how to use the Orodispersible tablet these marketing team personally serve to the new admitted patients.
The main objective of the present research work is to formulate the Clopidogrel Fast Dissolving tablets. Clopidogrel, an antiplatelet drug, belongs to BCS Class-II and used to control Heart attack, Hypertension by inhibiting Platelet activation and aggregation .The Fast Dissolving tablets of Clopidogrel were prepared employing different concentrations of Crospovidone and Croscarmellose sodium in different combinations as a Superdisintegrant 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, t50%, t90% were selected as dependent variables. Totally nine formulations were designed and evaluated for hardness, friability, thickness, Assay, Wetting time, Disintegration time, and 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 into different Kinetic models, the statistical parameters like intercept (a), slope (b) and regression coefficient (r) were calculated. Polynomial equations were developed for Wetting time, Disintegration time, t50%, t90%. Validity of developed polynomial equations was verified by designing 2 check point formulations (C1, C2). According to SUPAC guidelines, the formulation (F5) containing combination of 15% Crospovidone and 15% Croscarmellose, is the most similar formulation (similarity factor f2=91.3936, dissimilarity factor f1= 1.203& No significant difference, t= -0.00062) to marketed product (PLAVIX-75). The selected formulation (F1) follows First order, Higuchi’s kinetics, mechanism of drug release found to be Fickian Diffusion (n= 0.226).
Review on Formulation Approaches and Evaluation Parameters of Mouth Dissolvin...ijtsrd
Since the past decade, oral administration has received substantially more attention for the treatment or management of disorders. Mouth dissolving tablets MDTs , a novel idea in oral delivery, are now widely used. Mouth dissolving tablets are solid dosage forms that dissolve and release the active ingredient when placed in the mouth for a short period of time without the use of water. Geriatric, paediatric, and bedridden patients are particularly affected by it since they have swallowing issues, like those with dysphasia. This article discusses the various excipients evaluation tests, marketed formulations, and drugs used in his research area, along with the many formulation aspects and technologies developed for MDTs. The advancement in this field allows the development of an affordable and improved method of disease management with avoidance of numerous issues associated to the other delivery systems. Kamlesh R. Deshmane | Dr. V. U. Barge | Pratiksha B. Avhad "Review on Formulation Approaches and Evaluation Parameters of Mouth Dissolving Tablet" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-2 , April 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd55178.pdf Paper URL: https://www.ijtsrd.com.com/pharmacy/pharmaceutics/55178/review-on-formulation-approaches-and-evaluation-parameters-of-mouth-dissolving-tablet/kamlesh-r-deshmane
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.
ABSTRACT
The main objective of present research work is to formulate the floating tablets of Carvedilol Phosphate using 32 factorial design. Carvedilol Phosphate, non-selective α1-β1-blocking agent belongs to BCS Class-II and Indicated for treatment of Hypertension/moderate Heart Failure. The Floating tablets of Carvedilol Phosphate were prepared employing different concentrations of HPMCK100M and Sodium bicarbonate in different combinations by Direct Compression technique using 32 factorial design. The concentration of HPMCK100M and Sodium bicarbonate 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 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 (F8) containing combination of 25% HPMCK100M and 3.75% Sodium bicarbonate, is the most similar formulation (similarity factor f2=88.801, dissimilarity factor f1= 2.250 & No significant difference, t= 0.095) to marketed product (CARDIVAS). The selected formulation (F8) follows Higuchi’s kinetics, and the mechanism
This document discusses oral dissolving films (ODFs), which are thin films that dissolve quickly in the mouth. ODFs offer benefits like rapid onset of action, avoidance of first-pass metabolism, improved patient compliance, and ease of administration without water. The document reviews the process of ODF production, current products on the market, potential drugs that could be delivered via ODF, and a study developing a pantoprazole ODF using hydroxypropyl methylcellulose polymers. The study found that the lower viscosity HPMC LV polymer was more effective for rapid film disintegration and drug dissolution compared to the higher viscosity HPMC E 15 polymer.
ALPHA LOGARITHM TRANSFORMED SEMI LOGISTIC DISTRIBUTION USING MAXIMUM LIKELIH...BRNSS Publication Hub
The document discusses the alpha logarithm transformed semi-logistic distribution and its maximum likelihood estimation method. It introduces the distribution, provides its probability density function and cumulative distribution function. It then describes generating random numbers from the distribution and outlines the maximum likelihood estimation method to estimate the distribution's unknown parameters. This involves deriving the likelihood function and taking its partial derivatives to obtain equations that are set to zero and solved to find maximum likelihood estimates of the location, scale, and shape parameters.
AN ASSESSMENT ON THE SPLIT AND NON-SPLIT DOMINATION NUMBER OF TENEMENT GRAPHSBRNSS Publication Hub
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.
Walmart Business+ and Spark Good for Nonprofits.pdfTechSoup
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Main Java[All of the Base Concepts}.docxadhitya5119
This is part 1 of my Java Learning Journey. This Contains Custom methods, classes, constructors, packages, multithreading , try- catch block, finally block and more.
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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.
How to Make a Field Mandatory in Odoo 17Celine George
In Odoo, making a field required can be done through both Python code and XML views. When you set the required attribute to True in Python code, it makes the field required across all views where it's used. Conversely, when you set the required attribute in XML views, it makes the field required only in the context of that particular view.
Strategies for Effective Upskilling is a presentation by Chinwendu Peace in a Your Skill Boost Masterclass organisation by the Excellence Foundation for South Sudan on 08th and 09th June 2024 from 1 PM to 3 PM on each day.
Leveraging Generative AI to Drive Nonprofit InnovationTechSoup
In this webinar, participants learned how to utilize Generative AI to streamline operations and elevate member engagement. Amazon Web Service experts provided a customer specific use cases and dived into low/no-code tools that are quick and easy to deploy through Amazon Web Service (AWS.)
2. Snigdhanjani and Teja: Formulation and in vitro evaluation mirtazapine oral disintegrating tablets
IJPBA/Jul-Sep-2021/Vol 12/Issue 3 136
tablets have been on the market for some time,
they are not the same as the new ODTs. Patients
for whom chewing is difficult or painful can use
these new tablets easily. ODTs can be used easily
in children who have lost their primary teeth but do
not have full use of their permanent teeth.[6,7]
ODTs technology, which makes the tablets
dissolve or disintegrate in the oral cavity without
any additional water intake, has drawn a great deal
of attention. ODTs are a solid dosage form that
provides the rapid disintegration or dissolution
of solid to present as suspension or solution form
even when placed in the mouth under limited
biofluid.[2,8]
ODTs are known by various names
such as oral dispersible tablets, quick disintegrating
tablets, fast disintegrating tablets, fast or rapid
dissolving tablets, porous tablets, mouth dissolving
tablets, and rapimelts. The excipients used in
ODT technology are usually hydrophilic in
nature and can be selected on the basis of drug’s
physicochemical properties such as hydrophilicity
or hydrophobicity. If the active pharmaceutical
ingredient is hydrophobic in nature, then dosage
form is called disintegrating tablet whereas, if it
is hydrophilic, then the dosage form is called fast
dissolving tablet. The ODT formulation defined
by the Food and Drug Administration (FDA) as “a
solid dosage form containing medicinal substances
which disintegrates rapidly, usually within a matter
of seconds when placed on the tongue.” The U.S.
FDA approved Zydis, ODT formulation of Claritin
(loratadine) in December 1996. It was followed by a
Zydis ODT formulation of Klonopin (clonazepam)
in December 1997, and a Zydis ODT formulation
of Maxalt (rizatriptan) in June 1998. Further, a
number of drugs have been approved by regulatory
authorities for ODT formulations. The aim of this
article is to review the advantages, limitations,
formulation challenges, manufacturing techniques,
patented technologies, marketed formulations, and
evaluation tests of ODTs.[2,8-19]
Drug Profile
Mirtazapine
Description
Mirtazapine is a tetracyclic piperazino-azepine
antidepressant agent that was initially approved for
the treatment of major depressive disorder (MDD)
in the Netherlands in 1994.
This drug was first manufactured by Organon
Inc. and received FDA approval in 1997 for the
treatment of MDD. The effects of this drug may
be observed as early as 1
week after beginning
therapy.
In addition to its beneficial effects in depression,
mirtazapine has been reported to be efficacious
in the off-label management of various other
conditions. It may improve the symptoms of
neurological disorders, reverse weight loss caused
by medical conditions, improve sleep, and prevent
nausea and vomiting after surgery.
Excipient Profile
Sodium starch glycolate
Synonyms: Carboxymethyl starch, sodium salt;
Explosol; Glycolys.
Chemical Name and CAS Registry Number:
Sodium carboxymethyl starch [9063-38-1].
Applications in Pharmaceutical Formulation
or Technology
It is widely used in oral pharmaceuticals as a
disintegrant in capsule and tablet formulations
[Figure 1]. It is commonly used in tablets prepared
by either direct compression or wet granulation
processes [Figure 2]. The usual concentration
employed in a formulation is between 2% and
8%, with the optimum concentration about
4%, although in many cases, 2% is sufficient
Figure 1: Solubility of mirtazapine
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IJPBA/Jul-Sep-2021/Vol 12/Issue 3 137
[Figure 3]. Disintegration occurs by rapid uptake
of water followed by rapid and enormous swelling.
Althoughtheeffectivenessofmanydisintegrantsis
affected by the presence of hydrophobic excipients
such as lubricants, the disintegrant efficiency of
sodium starch glycolate is unimpaired. Increasing
the tablet compression pressure also appears to
have no effect on disintegration time. Sodium
starch glycolate has also been investigated for use
as a suspending vehicle.
Description
Sodium starch glycolate is a white to off-white,
odorless, tasteless, free-flowing powder. The PhEur
2005 states that it consists of oval or spherical
granules, 30–100 μm in diameter, with some less
spherical granules ranging from 10 to 35 μm in
diameter [Tables 1 and 2].[20-34]
Table 1: Materials used
S. No. Materials Company
1. Mirtazapine Spectrum Labs; Hyderabad.
2. Sodium starch glycolate Signet Chemical Corp., Mumbai
3. Croscarmellose sodium Signet Chemical Corp., Mumbai
4. Crospovidone Signet Chemical Corp., Mumbai
5. Aspartame Signet Chemical Corp., Mumbai
6 Microcrystalline cellulose Aurobindo Pharma Ltd.;
Hyderabad.
7. Talc S.D. Fine Chem. Ltd.; Chennai.
9 Magnesium stearate S.D. Fine Chem. Ltd.; Chennai.
Figure 2: Infrared spectrum of mirtazapine
Figure 3: Infrared spectrum of mirtazapine and excipients
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IJPBA/Jul-Sep-2021/Vol 12/Issue 3 138
RESULTS AND DISCUSSION
Solubility Studies
Solubility of mirtazapine was carried out at 25°C
using 0.1 N HCl, 6.8 phosphate buffer, 7.4 pH
buffer, and purified water.[35,36]
Medium Solubility (mg/ml)
Water 0.793
0.1 N HCl 0.452
6.8 pH buffer 0.741
7.4 pH buffer 0.628
Drug Excipient Compatibility
Drug and excipient compatibility was confirmed
by comparing spectra of Fourier transform infrared
analysis of pure drug with that of various excipients
used in the formulation.
DISCUSSION
Form the drug excipient compatibility studies, we
observe that there are no interactions between the
pure drug (mirtazapine) and optimized formulation
(Mirtazapine + Excipients) which indicates that
there are no physical changes.
SUMMARY AND CONCLUSION
• The present study is an attempt to select the best
possible disintegrant – subliming combination
to formulate oral disintegrating tablets of
mirtazapine, which disintegrates in matter of
seconds in the oral cavity, thereby reducing the
time of onset of pharmacological action.
• SSG and CCS were used as disintegrants. In all
the formulations, magnesium stearate and talc
were used as lubricant and glidant, respectively.
• The results of the drug-excipient compatibility
studies revealed that there was no chemical
interaction between the pure drug and
excipients.
• Sublimationmethodwasemployedtoformulate
the tablets, because of its cost-effectiveness
and due to reduced number of manufacturing
steps.
• The pre-compression parameters such as bulk
density, tapped density, Carr’s index, and angle
of repose were determined.All the formulations
showed acceptable flow properties.
• The post-compression parameters such as
the hardness, thickness, friability and weight
variation, disintegration time, disintegration
time in oral cavity, and in vitro release were
carried out and the values were found to be
within IP limits.
• The percentage drug content of all the tablets
was found to be between 82.24 and 98.16% of
mirtazapine, which was within the acceptable
limits.
• Among all the formulations, F9 shows 99.13%
drug release at the end of 20 min. F9 contains
camphor (30
mg), it shows better % drug
release when compared to other formulations.
• Hence, F9 was considered as the optimized
formulation.
• The drug release kinetics shows that the
optimized formulation F9 follows first-order
drug release.
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