Studies On Enteric Dissolving Fast Buccal Disintegrating Tablets Of Roxithromycin

Roxithromycin(RXM) is a semisynthetic macrolides antibiotic with a broad and essentially bateriostatic action against many Gram-positive and some Gram-negative bacteria, as well as some anaerobes. Roxithromycin has been widely used clinically to treat respiratory tract infection, urogenifal infection, skin and soft tissue infections etc, especially as the first picked medicine to therapy pediatric respiratory tract infection. The purpose of the present study was designed to develop a kind of enteric dissolving fast buccal disintegrating tablet which would improve its bioavailability, and which would be more convenient for patients to use.The HPLC ultraviolet method was developed for determining the roxithromycin content in tablets; the UV method for assay in vitro during the studies about physicochemical properties and release of roxithromycin; The HPLC ultraviolet method was established to monitor the plasma concentration in dogs.The preformulation results showed that roxithromycin was soluble in acid solutions and less soluble with boosted pH value. The stability of roxithromycin in several pH fluids showed that it was less stable as pH value reduced. The octanol/water partition coefficients increase with pH rising in various physiological pH fluids. If roxithromycin was made into enteric dosage form, the stability of roxithromycin in gastric juice will be advanced, and the release of microspheres in intestinal juice will be improved.In pharmaceutical research, firstly, the enteric dissolving roxithromycin...