We demonstrate the use of modeling and simulation to investigate bioequivalence (BE) concerns raised about generic warfarin products. To test the hypothesis that the loss of isopropyl alcohol and slow dissolution in acidic pH has significant impact on the pharmacokinetics of warfarin sodium tablets, we conducted physiologically based pharmacokinetic absorption modeling and simulation using form...

Carbamazepine oral suspension (100mg/5ml), 100mg and 200mg chewable tablets are proposed for addition to the Model List of Essential Medicines, for use in the management of epilepsy in children. It is at least as effective as phenobarbitone, phenytoin and sodium valproate in the management of partial and tonic-clonic seizures in children. Carbamazepine is available in the UK as a sugar free ora...

Dissolution profiles were developed in three different pH media for the evaluation of valsartan/amlodipine (VS/AM) release from tablets. The selection of the most appropriate dissolution method was based on the calculated similarity (f2) and dissimilarity (f1) values. A new HPLC method was developed to quantify VS/AM in tablets. The method was validated in accordance with international guidelin...

Preformulation is an important step in the rational formulation of an active pharmaceutical ingredient (API). Micromeritics properties: bulk density (BD) and tapped density (TD), compressibility index (Carr's index), Hauser's ratio (H), and sieve analysis were performed in order to determine the best excipients to be used in the formulation development of omeprazole magnesium enteric coated tab...

Changes in the hardness, dissolution, and the disintegration time of brand name and generic preparations (6 preparations) of famotidine orally disintegrating tablets were investigated. Tablets had been stored in a thermo-hygrostat-controlled environment set to simulate the home conditions of patients up to 8 weeks after unit-dose packaging. Among the tablets in unit-dose packaging prepared imme...

Objectives. We evaluated the ingestibility and formulation quality of one branded (formulation A) and five generic (formulations B, C, D, E, and F) lansoprazole orally disintegrating (OD) tablets. Methods. Ingestibility, including the oral disintegrating time, taste, mouth feeling, and palatability, was examined by sensory testing in healthy subjects. Formulation qualities, including salivary s...

BACKGROUND New technologies provide opportunities for the delivery of broad, flexible interventions with older adults. Focus groups were conducted to: (1) understand older adults' familiarity with, and barriers to, interacting with new technologies and tablets; and (2) utilize user-engagement in refining an intervention protocol. METHODS Eighteen older adults (65-76 years old; 83.3% female) w...

Omeprazole is a potent proton pump inhibitor with powerful inhibition of secretion of gastric juice. Oral site-specific drug delivery systems have recently attracted a great interest for the local treatment of bowel disease and for improving systemic absorption of drugs which are unstable in the stomach. However, microenvironment in the gastrointestinal tract and varying absorption mechanisms c...