Single-chamber osmotic pump controlled release tablet containing pregabalin

Abstract

The invention discloses a single-chamber osmotic pump controlled release tablet containing pregabalin. The tablet comprises a single-layer piece core, a controlled release film coating layer and at least one laser hole in a controlled release film. The basic composition of the piece core includes pregabalin or salt or hydrate thereof, diluent, adhesive and lubricant, and does not include an expansible polymer. The adopted accessories are simple and economical, the tablet can be prepared through a simple direct tabletting process, and the controlled release film coating layer includes a film forming material, a pore-foaming agent and plasticizer. According to the drug release mechanism, water and a physiological medium dissolve water-soluble active components and the diluent in the piece core through the controlled release film to form trans-film osmotic pressure, the dissolved active components are released out of the piece core through the small holes in the controlled release film, the controlled release tablet can release a therapeutic drug within a certain time range at a constant drug release rate, and the influence of the stomach and intestine difference between different individuals on drug absorption can be minimized.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a controlled-release tablet containing pregabalin, which is suitable for (QD) oral administration once a day. Background technique [0002] The chemical name of pregabalin is (S)-(+)3-aminomethyl-5-methylhexanoic acid. and is associated with the endogenous inhibitory neurotransmitter γ-aminobutyric acid (GABA). Pregabalin is used to treat conditions such as epilepsy, neuropathic pain, and fibromyalgia. The commercially available immediate-release (IR) dosage form of pregabalin is common capsule, and the dosage is 2-3 times a day. [0003] Compared with taking more than 2 times a day, the QD administration form can improve the patient's medication compliance; reduce the maximum blood concentration and avoid a sudden increase in blood concentration, thereby reducing any dose-related side effects; increase effective blood drug The maintenance time of the concent...

AI Technical Summary

Problems solved by technology

This dosage form has changed matrix material on the basis of the dosage form disclosed in CN101330907A, although sodium alginate and calcium hydrogen phosphate have optimized tablet swelling size and skeleton rigidity as matrix material, but with Compared with SR, its performance will be affected by ions or salts and pH, and the ionic groups in excipients also have compatibility risks

CN103702664A discloses a sustained-release tablet containing pregabalin through a two-phase controlled-release system. The expansion and buoyancy of the two-phase display of the dosage form can achieve effective gastric retention, and can minimize individual gastrointestinal motility differences. The two-phase control drug The release is not prone to burst release, but the drug-containing controlled release phase adopts the wet granulation preparation process. Compared with the direct compression process, the process is cumbersome and there is a risk of process enlargement

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