Pregabalin composition suitable for powder tabletting and application thereof

Abstract

The invention discloses a pregabalin composition suitable for powder tabletting, the active component pregabalin of the pregabalin composition is pregabalin with a square crystal habit, the particle size range is D90: 350-600 [mu] m, and the dosage accounts for 20-50% of the total weight of the prescription. The pregabalin composition further comprises a filling agent, a disintegrating agent, a flavoring agent, essence and a lubricating agent. The invention provides another idea that the pregabalin bulk drug with a certain particle size range and a specific crystal habit form is prepared, and compared with the common pregabalin bulk drug, the compressibility of the prepared total mixed material is obviously improved, and the production cost is reduced.

Description

technical field

[0001] The invention belongs to the field of medicine, and in particular relates to a pregabalin composition suitable for powder compression. Background technique

[0002] Internationally, the immediate-release oral solid preparations of pregabalin on the market are tablets, capsules, and orally disintegrating tablets. Compared with ordinary tablets and capsules, orally disintegrating tablets can quickly disintegrate in the oral cavity under the condition of no water or only a small amount of water, especially suitable for the elderly, children, and patients with difficulty swallowing.

[0003] Pregabalin or (S)-(+)-3-aminomethyl-5-methyl-hexanoic acid can bind to the α-2-δ (α2δ) subunit of calcium channels and is involved in brain neuronal activity The regulation of related endogenous inhibitory neurotransmitter γ-aminobutyric acid (GABA) is related. As described in U.S. Patent 5,563,175, pregabalin has anti-seizure activity and is indicated for the treatm...

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