Dissolution of pantoprazole tablet
Pantoprazole sodium sesquihydrate is highly unstable at low pH values, so, it is formulated as enteric coated tablets or capsules.
Diluted McIlvaine Buffer [ Phosphate buffered saline with 0. The similarity factor f2 was assessed using the FDA recommended approach f2 similarity factor.
Sodium phosphate buffer, pH 6. I Basket with modified diameter of IV Flow through cell It is used for the treatment of gastrointestinal conditions particularly peptic ulceration, Zollinger—Ellison syndrome and reflux esophagitis Cheer et al.
McIlvaine buffer, pH 3. Phosphate buffer at pH 7.
The results obtained from this comparative study concluded that there was a similarity between the innovator and the generic products except generic product 1, which showed a significant variation in the in vitro release pattern compared with the innovator. The results of weight and thickness parameters are expressed as mean and relative standard deviation in Table 1. Dissolution profiles for each product were compared to the innovator to determine the enteric coating efficacy of the generic products.
Introduction A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Deionized water with 0. American Journal of Health-System Pharmacy.
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SIF without enzyme from end of hour 1 through the duration of the testing. Sodium Phosphate Buffer, pH 6.
About this Database Back to Search Page. Tablet dissolution in 0. Analytical Profiles of Drug Substances and Excipients.
The media used was 0. One tablet of each product was placed in each of the six tubes of the basket. I Basket, 10 mesh [with option of tablet holder] Met: I 10 mesh rotating Basket Niacin: