tablets
Mechanistic Understanding of Food Effects: Water diffusivity in GI is an Important Parameter For Prediction of Disintegration of Solid Oral Dosage Forms
Tue, 2014-11-11 14:52 — Asma Abdelaziz Salim RadwanMuch interest has been expressed in this work on the role of water diffusivity in the release media as a new parameter for predicting drug release. NMR was used to measure water diffusivity in different media varying in their osmolality and viscosity. Water self-diffusion coefficients in sucrose, sodium chloride, and polymeric hydroxypropyl methylcellulose (HPMC) solutions were correlated with water uptake, disintegration, and drug release rates from trospium chloride immediate release tablets. The water diffusivity in sucrose solutions was significantly reduced compared to polymeric HPMC and molecular sodium chloride solutions. Water diffusivity was found to be a function of sucrose concentration in the media. Dosage form disintegration and drug release was to be affected by water diffusivity in these systems. This observation can be explained by hydrogen bonding formation between sugar molecules, an effect which was not expressed in sodium chloride solutions of equal osmolality. Water diffusivity and not media osmolality in general need to be considered to predict the effect of disintegration and dissolution media on drug release. Understanding the relevance of water diffusivity for disintegration and dissolution will lead to better parametrization of dosage form behavior in gastrointestinal (GI) aqueous and semisolid media.
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Interchangeability of Two 500 mg Amoxicillin Capsules With One 1000 mg Amoxicillin Tablet After A Single Oral Administration
Sun, 2014-06-29 12:29 — Abdel Naser ZaidThe aim of the study was to evaluate if two capsules (Amoxil(®) capsules, 500 mg/capsule) and one tablet (Amoxicare(®) tablets, 1000 mg/tablet) of amoxicillin have similar bioequivalence parameters. For this purpose a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy, male volunteers, divided into two groups of 12 subjects each. One group was treated with the reference standard (Amoxil(®)) and the other one with the generic tablet Amoxicare(®), with a crossover after a wash-out period of 7 days. Blood samples were collected at fixed time intervals and amoxicillin was determined by a validated HPLC method. The pharmacokinetic parameters AUC(0-8), AUC(0-∞), C(max), T(max), K(e) and T(1/2) were determined for both formulations and statistically compared to evaluate the bioequivalence between the two brands of amoxicillin, using the statistical model recommended by the FDA. C(max) and AUC(0-∞) were statistically analyzed using analysis of variance (ANOVA); no statistically significant difference was observed between the two formulations. The 90% confidence intervals between the mean values of C(max) and AUC(0-∞) fall within the FDA specified bioequivalent limits (80-125%) suggesting that the two products are bioequivalent and the two formulations are interchangeable. Based on these findings it was concluded that the practice of interchangeability between the above formulations to achieve better patient compliance could be followed without compromising the extent of amoxicillin absorption.
Development of Film Coated Atrovastatin Calcium Tablet Using OPADRY-OYV
Wed, 2014-06-25 10:23 — Abdel Naser ZaidThe aim of this study was to develop and evaluate the stability of film coated Atorvastatin Calcium (AtC) tablets using Opadry-OY-B-28920. AtC uncoated tablets were developed and manufactured through the Wet Granulation process. Opadry-OY-B-28920 white aqueous coating dispersion was used as film coating material. The film coated tablets were completely disintegrated within 10 minutes in water media, it was also completely dissolved (more than 85% of the drug was released) within 30 minutes in pH 6.8 buffer solutions. The film coated tablets were studied under both long term and accelerated stability study and the results showed no significant variation in physical characteristics, color, hardness, no obvious defects or signs of peeling or chipping. These results reflect that the film coated system Opadry-OY-B-28920 can be successfully used in order to produce AtC film coated tablet that is protected from environmental conditions such as light and humidity.These findings suggest that aqueous film coating with Opadry-OY-B-28920 system is an easy and economical approach for preparing stable film coated AtC tablet of immediate release.
Interchangeability of Two 500 Mg Amoxicillin Capsules with One 1000 Mg Amoxicillin Tablet After a Single Oral Administration
Thu, 2013-02-14 17:09 — Professor Waleed M. SweilehThe aim of the study was to evaluate if two capsules (Amoxil® capsules, 500 mg/capsule) and one tablet (Amoxicare® tablets, 1000 mg/tablet) of amoxicillin have similar bioequivalence parameters. For this purpose a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy, male volunteers, divided into two groups of 12 subjects each. One group was treated with the reference standard (Amoxil®) and the other one with the generic tablet Amoxicare®, with a crossover after a wash-out period of 7 days. Blood samples were collected at fixed time intervals and amoxicillin was determined by a validated HPLC method. The pharmacokinetic parameters AUC0-8, AUC0-∞, Cmax, Tmax, Ke and T1/2 were determined for both formulations and statistically compared to evaluate the bioequivalence between the two brands of amoxicillin, using the statistical model recommended by the FDA. Cmax and AUC0-∞ were statistically analyzed using analysis of variance (ANOVA); no statistically significant difference was observed between the two formulations. The 90% confidence intervals between the mean values of Cmax and AUC0-∞ fall within the FDA specified bioequivalent limits (80-125%) suggesting that the two products are bioequivalent and the two formulations are interchangeable. Based on these findings it was concluded that the practice of interchangeability between the above formulations to achieve better patient compliance could be followed without compromising the extent of amoxicillin absorption.
Development of Film Coated Atrovastatin Calcium Tablet Using OPADRY-OY
Thu, 2013-02-14 09:56 — Shehdeh JodehThe aim of this study was to develop and evaluate the stability of film coated Atorvastatin Calcium (AtC) tablets using Opadry-OY-B-28920. AtC uncoated tablets were developed and manufactured through the Wet Granulation process. Opadry-OY-B-28920 white aqueous coating dispersion was used as film coating material. The film coated tablets were completely disintegrated within 10 minutes in water media, it was also completely dissolved (more than 85% of the drug was released) within 30 minutes in pH 6.8 buffer solutions. The film coated tablets were studied under both long term and accelerated stability study and the results showed no significant variation in physical characteristics, color, hardness, no obvious defects or signs of peeling or chipping. These results reflect that the film coated system Opadry-OY-B-28920 can be successfully used in order to produce AtC film coated tablet that is protected from environmental conditions such as light and humidity.These findings suggest that aqueous film coating with Opadry-OY-B-28920 system is an easy and economical approach for preparing stable film coated AtC tablet of immediate release.
