film coating
Comparative fasting bioavailability of two clopidogrel formulations in healthy Mediterranean volunteers: an in vitro–in vivo correlation
Thu, 2015-08-06 09:08 — Abdel Naser ZaidThe aim of this study was to evaluate the bioequivalence of two drug products, generic clopidogrel bisulfate 75 mg film-coated tablets versus the reference Plavix(®) clopidogrel bisulfate 75 mg film-coated tablets.
METHODS:
Bioequivalence of tablets was tested by comparisons against the reference brand product in accordance with the requirements of the Declaration of Helsinki, the current Good Clinical Practice Guidelines, and the International Conference on Harmonization.
RESULTS:
The relationship between concentration and peak area ratio was found to be linear within the range 24.500-1,836.600 pg/mL for clopidogrel. The correlation coefficient (r) was always greater than 0.99 during the course of the validation. Statistical comparison of the main pharmacokinetic parameters showed no significant difference between test and reference. The point estimates (ratios of geometric mean) were 104.122%, 104.184%, and 109.091% for areas under the plasma concentration-time curve (AUC) AUC0-last, AUC0-∞, and peak plasma concentration C max, respectively. These pharmacokinetic parameter values of clopidogrel and its main metabolite lie within the bioequivalence limit (80%-125%) specified by the US Food and Drug Administration and the European Medicines Agency.
CONCLUSION:
The tested drug product was bioequivalent to the reference drug under fasting conditions and had the same safety profile, which is important to achieve equivalent therapeutic effect with the reference.
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TwitterDevelopment 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.
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.
