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
The in vitro release of plasmid DNA and salmon sperm DNA from in situ gel formulations was investigated. Two in situ gel systems were studied: (a) an interpolymeric complex (IPC) of water-soluble polymers polymethacrylic acid (PMA) and polyethylene glycol (PEG) and (b) a hydroxypropylmethylcellulose-carbopol system (H:C). Two-way analysis of variance with replication demonstrated that both gel composition and medium pH influenced significantly the release of plasmid DNA from in situ gel formulations. When the release of both types of DNA was compared, higher release was observed for plasmid DNA compared to genomic salmon sperm DNA. Conformational analysis of the released plasmid DNA showed that DNA was released without degradation, but with remarkable conversion from supercoiled (SC) to open circular (OC). In addition, the tested in situ gel systems demonstrated protection from DNAse I degradation. The myotoxicity of the injectable gelling solutions was assessed by the cumulative release of creatine kinase (CK) over 120 min from the isolated rodent extensor digitorum longus (EDL) muscle. A higher level of cumulative CK was observed for IPC when compared to H:C (2:1). These results demonstrate that the in situ gelling systems can be considered as a valuable injectable controlled-delivery system for pDNA in their role to provide protection from DNAse degradation.
Subject(s)
DNA/administration & dosage , Drug Delivery Systems , Muscle, Skeletal/drug effects , Plasmids , Animals , DNA/toxicity , Female , Gels , Hydrogen-Ion Concentration , Rats , Rats, Sprague-DawleyABSTRACT
Studies on chemical changes induced by gamma-irradiation at optimum dose of 75 krad in carrots were undertaken. Sugars, nitrogen, free amino acids, amino acids of alcohol insoluble solids, and pectin fractions were determined. The results indicate that the postharvest irradiation of carrots does not dramatically affect their chemical composition during storage. However, it was observed that storage time affected significantly the biochemical changes occurring in the constituents of carrots exposed to gamma-irradiation.
Subject(s)
Food Irradiation , Vegetables/radiation effects , Amino Acids/analysis , Carbohydrates/analysis , Nitrogen/analysis , Vegetables/analysisABSTRACT
This paper deals with the effect of postharvest gamma-irradiation of strawberries and carrots on their organoleptic quality, storage capacity and chemical composition. Radiation doses of 25 krad for strawberries and 75 krad for carrots were chosen as optimum doses not causing significant changes in the organoleptic quality. We found that strawberries and carrots irradiated at a doseof 25 and 75 krad respectively, retained its microbiological stability even during storage at 12 degrees C (strawberries) and at 25-30 degrees C (carrots), respectively. It was also found that changes in chemical composition depend on storage temperature and time and are not affected substantially by irradiation.
