Famotidine high density type gastric retention osmotic pump controlled release preparation and preparation method thereof

A technology of osmotic pump controlled release and famotidine, which is applied in the field of famotidine high-density gastric retention osmotic pump controlled release preparation and its preparation, which can solve the problems of low bioavailability and short residence time of drugs

Inactive Publication Date: 2009-03-11
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] On the other hand, although most of the sustained and controlled release systems can well control the release of drugs from the system, the bioavailability of the drugs is not high. This is due to the short residence time of these preparations in the gastrointestinal tract, and many drugs have not Released, absorbed and passed through the site of absorption

Method used

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  • Famotidine high density type gastric retention osmotic pump controlled release preparation and preparation method thereof
  • Famotidine high density type gastric retention osmotic pump controlled release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Tablet prescription:

[0026] Famotidine 40mg

[0027] N12K 30mg

[0028] NaCl 50mg

[0029] Medicinal iron powder 150mg

[0030] Magnesium Stearate 1mg

[0031] Semi-permeable coating film prescription:

[0032] Cellulose acetate 20g

[0033] PEG4000 3g

[0034] Solvent prescription for dissolving film coating material:

[0035] Acetone 1000ml

[0036] water 20ml

[0037] Preparation Process:

[0038] Pass the prescribed amount of medicine, N12K, NaCl, medicinal iron powder and magnesium stearate through an 80-mesh sieve, mix evenly, and directly use No. 7 punched tablets to obtain tablet cores. Dissolve cellulose acetate and PEG4000 in acetone and water respectively and mix evenly, coat the tablet core with a coating pan, with a weight gain of 7%, and cure in an oven at 40°C for 12 hours after coating. Then prepare a 0.8 mm diameter release hole with a mechanical drill on one side of the coated tablet to obtain the controlled-release preparation of the famo...

Embodiment 2

[0040] Tablet prescription:

[0041] Famotidine 40mg

[0042] Sodium Alginate 80mg

[0043] Lactose 20mg

[0044] Medicinal iron powder 137.5mg

[0045] Micronized silica gel 1mg

[0046] Semi-permeable coating film prescription:

[0047] Cellulose acetate 15g

[0048] PEG6000 2g

[0049] Solvent prescription for dissolving film coating material:

[0050] Acetone 500ml

[0051] water 30ml

[0052] Preparation Process:

[0053]Pass the prescribed amount of medicine, sodium alginate, lactose, medicinal iron powder and micronized silica gel through an 80-mesh sieve, mix evenly, and directly use No. 7 punched tablets to obtain tablet cores. Dissolve cellulose acetate and PEG6000 in acetone and water respectively and mix evenly, coat the tablet core with a coating pot, the weight gain is 8%, and cure in an oven at 40°C for 12 hours after coating. Then, a 0.6 mm diameter drug release hole was prepared with a mechanical drill on both sides of the coated tablet to obtain th...

Embodiment 3

[0055] In vitro cumulative release of famotidine high density gastric retention osmotic pump tablets

[0056] According to "Pharmacopoeia of the People's Republic of China" 2005 edition two release determination method first method, the release medium is 900mL 0.1mol L -1 HCl, speed 100r·min -1 , Medium temperature (37±0.5)℃. 5 mL samples were taken at 2, 4, 6, 8, 10 and 12 hours respectively, and an equal volume of isothermal release medium was added at the same time. Dilute appropriately after passing through a 0.8μm microporous membrane, take the release medium as a blank, measure the absorbance at 266nm, and calculate the cumulative release.

[0057] attached figure 1 Represented is the in vitro cumulative 12-hour release percentage-time curve of the famotidine high-density gastric retention osmotic pump tablet prepared according to Example 1, and the results show that although the present invention makes a single-layer osmotic pump preparation for insoluble drugs, the...

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Abstract

The invention belongs to the technical field of pharmaceutical preparation and discloses a high-density gastric stasis osmotic pump controlled release famotidine preparation and a preparation method thereof. The osmotic pump controlled release preparation is made from a tablet core containing famotidine and a semi-permeable coating membrane with drug release pores which is coated outside the tablet core; the tablet core is made from 400mg of the famotidine, 100-150mg of medicinal ferrous powder, 30-90mg of a suspension, 20-80mg of an osmotic pressure active material and 0.5-2mg of a lubricant; the semi-permeable coating membrane is made from 10-20g of a semi-permeable polymer material and 2-5g of a water-soluble pore making agent, and accounts for 5-9% of the weight of the tablet core; and the drug release pores are drilled at one side or two sides of a coating tablet by laser and by mechanical means. The medicinal ferrous powder is added to the tablet core to cause the drug to be more completely released from the drug release pores; meanwhile, the medicinal ferrous powder increases the density of the preparation; therefore, the preparation is stagnated in the folds of the lower part of the stomach, which greatly prolongs the release time of the pharmaceutical preparation in the stomach and improves the absorption capacity of the pharmaceutical preparation.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a controlled-release preparation of famotidine high-density gastric retention osmotic pump and a preparation method thereof. Background technique [0002] Famotidine, also known as mesultamide, is a third-generation histamine H with strong action, long-lasting and good curative effect. 2 Receptor antagonist for the treatment of gastric and duodenal ulcers and acute gastrointestinal diseases. It went on the market in Japan in 1985, was approved to go on the market in the United States in the same year, and was approved for production by Merck in October 1986. It was first sold as an over-the-counter drug in the UK in 1994 and is now on the market in more than 80 countries and regions. In 1989, my country approved the import and marketing of famotidine. In 1990, domestic enterprises successfully developed it. In 1992, famotidine raw materials and preparations wer...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K31/426A61P1/04
Inventor 潘卫三关津周丽莹
Owner SHENYANG PHARMA UNIVERSITY
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