Medicine composition containing active ingredients of pregabalin

A technology of active ingredients and compositions, applied in the field of pharmaceutical preparations, can solve problems such as unsatisfactory technical effects, and achieve the effects of reducing the number of times of taking medicines, reducing the peak-to-valley ratio, and prolonging the residence time

Active Publication Date: 2015-08-19
QILU PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The effect of general sustained-release preparation technology is not ideal. It is a better ide...

Method used

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  • Medicine composition containing active ingredients of pregabalin
  • Medicine composition containing active ingredients of pregabalin
  • Medicine composition containing active ingredients of pregabalin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 to 9

[0028]Prescriptions one to nine in Tables 1, 2, and 3 (corresponding to Examples 1 to 9 respectively) represent laboratory-scale compositions containing pregabalin and various excipients, and Table 4 represents the in vitro swelling of the above compositions and release behavior. Table 5 shows the stability of the examples (percentage of the main impurity lactam). For above embodiment, all components except magnesium stearate are mixed in the hopper mixer, and reach certain mixing homogeneity; Then magnesium stearate is crossed 40 mesh sieves, mix again, at 200 -Compressed into tablets with a tablet weight of 1125mg under a hardness of 300N.

[0029] Table 1 contains the pharmaceutical composition of pregabalin

[0030] composition

Prescription 1 (mg / tablet)

Prescription 2 (mg / tablet)

Prescription Three (mg / tablet)

Pregabalin

75

75

75

Polyvinyl acetate povidone blend

200

345

500

Croscarmellose Sodium

550 ...

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Abstract

The invention belongs to the field of medicinal preparations, and particularly relates to a pregabalin slow release medicine composition. The pregabalin slow release medicine composition comprises active ingredients and excipients, wherein the active ingredients are pregabalin or pharmaceutically acceptable salts of the pregabalin; the excipients comprise a matrix forming agent and a swelling agent; the matrix forming agent is a mixture of polyvinyl acetate and polyvinylpyrrolidone; the swelling agent is selected from one or any combination from croscarmellose sodium, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose and polyoxyethylene. The medicine composition is suitable for oral administration once in each day; the number of medication times is reduced; the blood concentration peak-to-valley ratio is reduced; meanwhile, the proper swelling agent is selected, so that the gastric retention can be reached, and the problem of stability caused by peroxides can also be avoided; the product stability is improved; the therapy effect can be achieved through once medication in each day; the effect of the medicine composition is equivalent to that of quick release preparations. The medicine composition is manly used for treating epilepsy, neuropathic pain and the like.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations. It specifically relates to a stable oral pharmaceutical composition capable of increasing gastric retention time, which is suitable for taking once a day. Background technique [0002] Pregabalin and alpha in the central nervous system 2 The -delta site, an accessory subunit of voltage-gated calcium channels, is of high affinity and is involved in the endogenous inhibitory neurotransmitter gamma-aminobutyric acid (GABA) associated with the regulation of brain neuronal activity. Pregabalin has anti-seizure activity and is indicated for the treatment of the following conditions: epilepsy, herpetic neuralgia, etc. Pregabalin capsules are immediate-release preparations, and when used for the treatment of the above indications, they are administered to patients 2 or 3 times a day. For patients who need long-term medication, QD medication can improve patient compliance. Taking t...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/197A61K47/32A61K47/34A61K47/38A61P25/08A61P25/00
Inventor 杨清敏李颖姜慧张明会
Owner QILU PHARMA HAINAN
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