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At least 469 records · Page 26Linked to original sources
PubMed1993

Biopharmaceutical factors in seizure control and drug toxicity.

Problems related to bioequivalence and bioavailability for four antiepileptic drugs (AEDs) are reviewed. Bioequivalence and bioavailability of AEDs can be affected by many factors, including physicochemical characteristics of the agent, the dosage form, and physiological condition of the patient. In 1988, breakthrough seizures prompted an FDA investigation of one company's generic carbamazepine tablets. Results indicated that the manufacturer had changed its source of carbamazepine, which led to a wide range of dissolution characteristics for different lots of tablets. In two separate studies, clonazepam was shown to be more rapidly absorbed in patients with a normal gastric pH than in those with a higher-than-normal gastric pH. With phenytoin, which exhibits nonlinear pharmacokinetics, differences in the rate and extent of absorption can adversely affect the bioavailability of this agent. Finally, the bioequivalence of generic primidone was contested in an adolescent girl who appeared to experience more frequent seizures with a generic product than with a trade formulation. The effectiveness of a drug depends on complex interactions involving the drug, the drug product formulation, and the patient. Minimizing variability in the absorption process is particularly important with AEDs, because of their narrow therapeutic range.

Anticonvulsants↗
PubMed1997

Applications of site-specific chemical modification in the manufacture of biopharmaceuticals: I. An overview.

The chemical modification of proteins has long been a useful approach to elucidating structure-function relationships. Recently, these same chemistries have been finding application in the preparation of proteins for both diagnostic and therapeutic use. These applications include alterations to introduce new properties, such as improved stability, or new traits, such as drug binding and transport, that take advantage of both broad and narrow ranges of selectivity. Site-specific chemical modification of proteins, when combined with the powerful advantages of site-specific mutagenesis, can yield protein agents superior to those generated by either approach alone.

Animals↗
PubMedDate not supplied

Biopharmaceutical characteristics of a new propranolol/hydrochlorothiazide tablet combination.

Experiments have been carried out in dogs and man to determine the effect of hydrochlorothiazide (HCT) on the pharmacokinetics of propranolol and to evaluate the bioavailability of two dosage forms containing both propranolol and HCT (40/25 and 80/25 mg, respectively). In adult male beagles, 50 mg of HCT had no apparent effect on AUC, Cmax, Tmax, and T1/2 of propranolol administered concurrently. In man, INDERIDE (40/25 mg) and INDERIDE (80/25 mg) were shown to be similar in bioavailability to the reference formulations, i.e. the same amount of drugs administered as the separate tablets of INDERAL plus HYDRODIURIL.

Adolescent↗