Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing cimetidine are reviewed. According to the current Biopharmaceutics Classification System (BCS), cimetidine would be assigned to Class III. Cimetidine's therapeutic use and therapeutic index, its pharmacokinetic properties...

Literature and new experimental data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing furosemide are reviewed. The available data on solubility, oral absorption, and permeability are sufficiently conclusive to classify furosemide into Class IV of the Biopharmaceutics Classification Sys...

the influence of various polymers on the release rate of lithium carbonate from matrix-type tablets was investigated in an attempt to formulate a sustained release solid dosage form. for this purpose, tablets containing 450 mg of lithium carbonate along with various amounts of carbopol 934p, 971p, 974p, pemulen and eudragit rlpo as retarding agents and inactive ingredients (e.g. pvp, avicel or ...

the objective of the study was to compare pharmacokinetic and pharmacodynamic parameters of gliclazide after administration of immediate (ir) and modified release (mr) tablets. the experiment included rats with both normoglyceamia and streptozocin (stz)-induced hyperglyceamia. several mr formulations were designed and in vitro drug release profile was assessed by a dissolution test. for the fur...

frequent dosing of the potent anti-androgen, flutamide, is necessary to reach a therapeutic level for the treatment of prostatic carcinoma. sustained delivery of the drug could reduce the adverse effects such as gastrointestinal disorders and improve patient compliance. in the present study sustained-release matrix tablets of flutamide were prepared by direct compression method using different ...

A method for assessing the extent of bioavailability (EBA) of human insulin from pharmacological data was determined. The time course governing increases in the plasma concentration of immuno-reactive insulin (IRI), as well as its pharmacological effects (glucodynamics), was determined after the intravascular administration of varying doses of human insulin. Pharmacokinetic (PK), pharmacodynami...

This study examines the controlled release behavior of both water-soluble (acetaminophen, caffeine, theophylline and salicylic acid) and water insoluble (indomethacin) drugs derived from Caesalpinia pulcherrima seed Gum isolated from Caesalpinia pulcherrima kernel powder. It further investigates the effect of incorporating diluents such as microcrystalline cellulose and lactose on caffeine rele...

A sustained-release tablet formulation should ideally have a proper release profile insensitive to moderate changes in tablet hardness that is usually encountered in manufacturing. In this study, matrix aspirin (acetylsalicylic acid) tablets with ethylcellulose (EC), Eudragit RS100 (RS), and Eudragit S100 (S) were prepared by direct compression. The release behaviors were then studied in two co...

DSM-PM2 is a platform for designing, implementing and experimenting multithreaded DSM consistency protocols. It provides a generic toolbox which facilitates protocol design and allows for easy experimentation with alternative protocols for a given consistency model. DSM-PM2 is portable across a wide range of clusters. We illustrate its power with figures obtained for different protocols impleme...