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Rapid melting misoprostol vaginal composition as well as preparation method and application of same

A technology of misoprostol and its composition, which is applied in the field of misoprostol vaginal composition and its preparation, can solve the problems of inaccurate dosage, tonic uterine contraction, and unqualified vaginal tablets when oral tablets are broken, and achieve Accurate dosage, satisfying safety and reliability, and satisfying the effect of medicinal requirements

Active Publication Date: 2012-10-03
REGENEX PHARMA LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The technical problem to be solved by the present invention is to provide a misoprostol vaginal composition with accurate dosage, reliable quality and fast melting to overcome the existing misoprostol oral tablet (specification: 200μg) or suppository (1- 6mg) is not suitable for induction of labor in late pregnancy, the dose is not accurate when the oral tablet is broken, the suppository dose is too large (1-6mg) to cause tonic uterine contraction, and the relevant substances of the currently disclosed vaginal tablet are unqualified

Method used

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  • Rapid melting misoprostol vaginal composition as well as preparation method and application of same
  • Rapid melting misoprostol vaginal composition as well as preparation method and application of same
  • Rapid melting misoprostol vaginal composition as well as preparation method and application of same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] A quick-melt misoprostol vaginal composition, comprising the following components by weight percentage:

[0035] Raw material: misoprostol-hypromellose (specification: 1%) 0.3%;

[0036] Filler: starch lactose 55.0%, lactose 39.1%;

[0037] Disintegrant: croscarmellose sodium 0.5%;

[0038] Lubricant: Silica 5.1%;

[0039] Also, the unit dose contains 25 μg of misoprostol.

[0040] Preparation method A:

[0041] The material formula after sieving is as follows:

[0042] Raw material: Misoprostol-Hypromellose (specification: 1%) 2.5g;

[0043] Filling agent: starch lactose 450g, lactose 320g;

[0044] Disintegrant: croscarmellose sodium 4g;

[0045] Lubricant: Silica 42g.

[0046] The specific operation steps are:

[0047]1) Misoprostol-hypromellose dispersion (specification: 1%), fillers, disintegrants, and lubricants are passed through a 100-mesh sieve.

[0048] 2) Misoprostol-hypromellose dispersion (specification: 1%) is mixed with filler and disintegrant i...

Embodiment 2

[0065] A quick-melt misoprostol vaginal composition, comprising the following components by weight percentage:

[0066] Raw material: misoprostol-hypromellose (specification: 1%) 1.5%;

[0067] Filler: Microcrystalline Cellulose 91.7%;

[0068] Disintegrant: sodium carboxymethyl starch 1.2%, croscarmellose sodium 3.1%;

[0069] Lubricant: Talc 2.5%;

[0070] Also, the unit dose contains 25 μg of misoprostol.

[0071] Preparation:

[0072] The material formula after sieving is as follows:

[0073] Raw material: Misoprostol-Hypromellose (specification: 1%) 2.5g;

[0074] Filler: microcrystalline cellulose 150g;

[0075] Disintegrant: sodium carboxymethyl starch 2g, croscarmellose sodium 5g;

[0076] Lubricant: Talc 4g.

[0077] The specific operation steps are the same as in Example 1, sample 2-1 is obtained according to preparation method A, and sample 2-2 is obtained according to preparation method B.

Embodiment 3

[0079] A quick-melt misoprostol vaginal composition, comprising the following components by weight percentage:

[0080] Raw material: misoprostol-hypromellose (specification: 1%) 0.7%;

[0081] Fillers: Starch 26.3%, Mannitol 63.2%;

[0082] Disintegrant: cross-linked polyvinylpyrrolidone 0.8%, dry starch 1.1%;

[0083] Lubricant: Silica 7.9%;

[0084] Also, the unit dose contains 25 μg of misoprostol.

[0085] Preparation:

[0086] The material formula after sieving is as follows:

[0087] Raw material: Misoprostol-Hypromellose (specification: 1%) 2.5g;

[0088] Filling agent: starch 100g, mannitol 240g;

[0089] Disintegrant: cross-linked polyvinylpyrrolidone 3g, dry starch 4g;

[0090] Lubricant: silicon dioxide 30g.

[0091] The specific operation steps are the same as in Example 1, sample 3-1 is obtained according to preparation method A, and sample 3-2 is obtained according to preparation method B.

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Abstract

The invention discloses a rapid melting misoprostol vaginal composition which comprises the following components according to weight percent: 0.1 to 2 percent of misoprostol-Hydroxypropyl methyl cellulose, 78 to 98 percent of loading agents, 0.2 to 10 percent of disintegrating agents and 1 to 10 percent of lubricant, wherein the misoprostol vaginal composition contains 25 microgramme. The invention further discloses a preparation method and application of the rapid melting misoprostol vaginal composition. the rapid melting misoprostol vaginal composition provided by the invention targetedly avoids that conventional magnesium stearate is taken as lubricant, and the prepared composition is good in content uniformity, so that the dose is ensured accuracy, and the composition is completely applicable to labor induction of late pregnancy and satisfies the requirements on safety and reliability for medicinal use.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical engineering, and in particular relates to a misoprostol vaginal composition with accurate dosage, safety, reliability and fast melting, as well as its preparation method and application. Background technique [0002] Induction of labor in the third trimester of pregnancy (also known as induction of labor at term) is to start the labor process by means of drugs and other means before natural labor, so as to achieve the purpose of childbirth. In today's society, the proportion of induced labor is increasing day by day. In the United States, the induction rate was 9.3% in 1990 and more than doubled to 22.3% in 2005. [0003] At present, the drugs used to induce labor in late pregnancy mainly include oxytocin, dinoprostone, and cargestant suppository at home and abroad. [0004] Oxytocin needs to be administered by intravenous infusion under the close supervision of medical staff, and the eff...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/48A61K31/5575A61K47/48A61K47/38A61P15/04
Inventor 彭苗彭贵子杨亚飞袁永玲左联卢智俊
Owner REGENEX PHARMA LTD
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