ABSTRACT
The pharmaceutical quality of 7 local omeprazole capsule brands in Egypt was assessed relative to the proprietary product (Losec). Drug content, content uniformity, drug release (using USP test for enteric coated articles and a modified release test) were determined. Products were subjected to a 3-month stability study. Of the 7 brands, 6 had satisfactory drug content and content uniformity. All brands passed the USP drug release test. The modified release test proved to be more discriminative. After 3 months storage, drug content of 3 brands remained > 90% and 2 of these brands maintained drug release above 75%. Changes in pellet appearance during storage were indicative of omeprazole chemical degradation.
Subject(s)
Anti-Ulcer Agents/standards , Omeprazole/standards , Analysis of Variance , Anti-Ulcer Agents/chemistry , Anti-Ulcer Agents/economics , Anti-Ulcer Agents/supply & distribution , Biological Availability , Capsules , Chemistry, Pharmaceutical , Drug Costs/statistics & numerical data , Drug Packaging/standards , Drug Stability , Drug Storage , Drug and Narcotic Control , Egypt , Humans , Humidity , Hydrogen-Ion Concentration , Omeprazole/chemistry , Omeprazole/economics , Omeprazole/supply & distribution , Product Surveillance, Postmarketing , Solubility , Tablets, Enteric-Coated/chemistry , Tablets, Enteric-Coated/standards , Tablets, Enteric-Coated/supply & distribution , Time FactorsABSTRACT
The pharmaceutical quality of 7 local omeprazole capsule brands in Egypt was assessed relative to the proprietary product [Losec[R]]. Drug content, content uniformity, drug release [using USP test for enteric coated articles and a modified release test] were determined. Products were subjected to a 3-month stability study. Of the 7 brands, 6 had satisfactory drug content and content uniformity. All brands passed the USP drug release test. The modified release test proved to be more discriminative. After 3 months storage, drug content of 3 brands remained > 90% and 2 of these brands maintained drug release above 75%. Changes in pellet appearance during storage were indicative of omeprazole chemical degradation
Subject(s)
Omeprazole , Anti-Ulcer Agents , Chemistry, Pharmaceutical , Drug Costs , Drug Stability , Drug Storage , Capsules , Tablets, Enteric-CoatedABSTRACT
Solid dispersions of hydrochlorothiazide (1) in mannitol (2) and in dihydroxypropyltheophylline (3) were prepared by melting and solvent methods. For both systems, phase diagrams of simple eutectic type were obtained. A significant increase in dissolution rate was observed for 1/2 and 1/3 physical mixtures and solid dispersion as compared to pure drug. Solubility of 1 in 2 and in 3 solution at 27 degrees C and 37 degrees C was studied. At 37 degrees C the water solubility of the drug increased 3.7 times using 0.4 mol X 1(-1) 3. The solubilization of the drug by 3 in water was due to the formation 1 : 1 soluble complex. 1 tablets from physical mixtures and solid dispersion were prepared. Effect of ageing on the physical properties of the prepared 1 tablets was investigated.
