Abstract

DESIGN DEVELOPMENT AND CHARACTERIZATION OF GASTRO RESISTANCE DOXYCYCLINE HYDROCHLORIDE TABLETS

Umesh Kumar Chaurasiya* and Brajpal Ahirwar

Abstract

Gastro-Resistance tablets are solid and single unit dosage forms meant for oral administration are formulated in such a way that to by pass the acidic environment to the stomach and release the active content in the basic environtment of the intestine. Doxycycline is an universal antibiotic use to treat gram negative infections where the susceptible organism was strongly proven to be present and also used to treat different microbial infections. It is an tetracycline antibiotic. Its half life is around 18 to 22 hours and 80% of the dose is absorbed through small intestine. The IR formulation of doxycycline cause adverse effects like diminish patient compliance and so does not give required therapeutic effect. The standard formulation of doxycycline cause vomiting and nausea up to three times higher then the other antibiotics. Because of vomiting and nausea the patient discontinue the medicament which had been prescribed by the physician. There are also impaired absorption of doxycycline from the immediate release formulation of doxycycline. There is also Hepatotoxicity associated with the standard formulation of doxycycline. Nausea, vomiting, glissitis, dysphagia, enterocolitis, Anorexia, monilial over growth in the anogenital region. All the disorder had been caused by both oral and intravenous administration of tetracyclines. When there is oral administration of tetracyclines in the form of tablets or capsule there are also instances of esophageal ulceration. The pH of small intestine in different regions was found to be 5 to 7 PH in duodenum, 6 to 7 PH in jejunum and 7 PH in ileum. Eudragit and HPMC phthalate polymers are selected where the dissolution properties are above PH 6.0 and PH 6.4 respectively.

Keywords: Doxycycline, disintegration, Superdisintegrants, HCl, enteric coating, Homeostatis, Hepatotoxicity.