Development, Formulation and Evaluation of a Bilayer Gastric Retentive Floating Tablets of Ranitidine Hcl and Clarithromycin Using Natural Polymers

Received: 01-Oct-2021 Accepted Date: Oct 15, 2021 ; Published: 30-Oct-2021

Editoral Note

Gastric retention systems are such systems, which increase the gastric retention time of the dosage form at the stomach and upper parts of the small intestine and suitable for the drugs having site specific absorption from the above sites. The controlled release of the drug from these systems at the preferred absorption site optimizes delivery of the drug, maximizing its therapeutic benefits and reduces side effects by permitting a large portion of the drug to be absorbed before passing through the lower gastro intestinal tract. Many attempts like floating drug delivery systems, swelling and expanding systems, polymeric bio adhesive systems, modified shape systems, high density systems and other delayed gastric emptying devices have been made in recent years to provide a dosage form with a longer gastric retention time and therefore more efficient absorption. Compared to these approaches, the Gastric Floating Drug Delivery System (GFDDS) developed has provided several advantages, as shown by the encouraging results reported earlier. Furthermore, the buoyancy action provided by the GFDDS seems to offer a greater safety for clinical uses than some of the above mentioned approaches. In fact, no adverse effects due to floating devices have been reported to date. GFDDS are also appropriate for drugs which are locally active to the gastric mucosa in the stomach, in particular case of antibiotic administration for Helicobacter pylori (H. Pylori) eradication in the treatment of peptic ulcer disease. Compared to these approaches, the Gastric Floating Drug Delivery System (GFDDS) developed has provided several advantages, as shown by the encouraging results reported earlier. Furthermore, the buoyancy action provided by the GFDDS seems to offer a greater safety for clinical uses than some of the above mentioned approaches. In fact, no adverse effects due to floating devices have been reported to date. GFDDS are also appropriate for drugs which are locally active to the gastric mucosa in the stomach, in particular case of antibiotic administration for Helicobacter pylori (H. Pylori) eradication in the treatment of peptic ulcer disease.

Polymers

Natural polymers have been used in the design of oral controlled drug delivery systems. In recent years, polymers derived from plant origin have evoked interest among pharmaceutical suitability because they are readily available, less-toxic, capable of chemical modifications, biodegradable and also biocompatible. In the present investigation three natural gums neem, damar and copal were selected for their applicability in the design of bilayer tablets having gastric floating layer of clarithromycin along with immediate release layer of ranitidine HCl. The reason behind the preparation of BGRFT of clarithromycin and ranitidine HCl is to overcome failure of H. Pylori eradication rates with conventional dosage forms of clarithromycin with concomitant administration of PPIs. Among the different diluents and super disintegrants used in the preparation of ranitidine HCl immediate release tablets, formulation FR10 prepared with low concentration of sodium starch glycolate (3%) and low quantity of the lactose gave maximum % drug release within 30 min was optimized for the preparation of the immediate release tablets. As we want to minimize the total bulk of the tablet for the immediate release layer hence this is considered as the optimized formulation which is used for further preparation of bilayer tablet because the drug release completed within 30 min and bulk is low.