An improved immediate release solid dosage form of naproxen with a certain particle size distribution for the intragranular portion, and a certain particle size distribution for the carbonate portion that allows naproxen to remain in solution and achieves fast dissolution and fast absorption of naproxen...
首先来看USP<1151>对Immediate-release(IR)的定义:observed when nodeliberate effort has been made to modify the drug substance release profile.即没有故意修饰药物的释放,比如使用崩解剂或润滑剂的胶囊和片剂,也被认为是Immediate release的。 EP Glossary中对Imme...
首先来看USP<1151>对Immediate-release(IR)的定义:observed when nodeliberate effort has been made to modify the drug substance release profile.即没有故意修饰药物的释放,比如使用崩解剂或润滑剂的胶囊和片剂,也被认为是Immediate release的。 EP Glossary中对Immediate-release(也叫Conventional-release)的定义:a ...
首先来看USP<1151>对Immediate-release(IR)的定义:observed when nodeliberate effort has been made to modify the drug substance release profile.即没有故意修饰药物的释放,比如使用崩解剂或润滑剂的胶囊和片剂,也被认为是Immediate release的。 EP Glossary中对Immediate-release(也叫Conventional-release)的定义:a ...
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 ethambutol dihydrochloride as the only active pharmaceutical ingredient (API) are reviewed. Ethambutol dihydrochloride is a Bi...
bioequivalence (BE) testing for the approval of immediate-release (IR) solid oral dosage forms containing the antimalarial drug primaquine phosphate as the only active pharmaceutical ingredient (API) are reviewed. On the basis of permeability data and solubility studies, primaquine phosphate was found ...
An abuse deterrent immediate release biphasic matrix solid dosage form that releases the drug at a desired rate for quick onset of action when a single unit or prescribed units of the dosage form are orally administered but exhibits a reduced rate of release when more than the prescribed number...
This guidance is developed for immediate release (IR) dosage forms and is intended to provide (1) general recommendations for dissolution testing; (2) approaches for setting dissolution specifications related to the biopharmaceutic characteristics of the drug substance; (3) statistical methods for compa...
Sunil Sadanand NadkarniVinod Kumar GuptaUSUS8263125 * May 19, 2005 Sep 11, 2012 Torrent Pharmaceuticals Limited Dosage form for high dose-high solubility active ingredients that provides for immediate release and modified release of the active ingredients...
Literature and experimental data relevant to the decision to allow a waiver ofin vivobioequivalence (BE) testing for the approval of immediate‐release (IR) solid oral dosage forms containing ketoprofen are reviewed. Ketoprofen's solubility and permeability, its therapeutic use and therapeutic index, ...