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Levetiracetam osmotic pump controlled release tablet and preparation method thereof

An osmotic pump controlled release, tablet core technology, applied in the field of medicine, can solve the problem of no obvious dose correlation, and achieve the effect of continuous drug release, stable drug release, and elimination of peak-to-valley phenomenon.

Inactive Publication Date: 2009-05-06
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Levetiracetam adverse reactions are not clearly dose-related

Method used

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  • Levetiracetam osmotic pump controlled release tablet and preparation method thereof
  • Levetiracetam osmotic pump controlled release tablet and preparation method thereof
  • Levetiracetam osmotic pump controlled release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Tablet prescription:

[0040] Levetiracetam 60%

[0041] Microcrystalline Cellulose 36.5%

[0042] PVP K30 2.5%

[0043] Magnesium Stearate 1.0%

[0044] ethanol, water

[0045] Semipermeable Membrane Prescription:

[0046] Cellulose acetate 80%

[0047] PEG-4000 20%

[0048] Preparation method: mix the prescribed amount of levetiracetam and microcrystalline cellulose according to the above ratio, mix PVP K30 and 30% ethanol to prepare a binder with a solid content of 10%, then wet granulate, and dry , sieved, added magnesium stearate and compressed into tablets to make tablet cores. Dissolve cellulose acetate and PEG-4000 in a mixed solution of acetone-water (mass ratio 95:5), release tablet cores in a coating pan for coating, and place the coated tablets in a dry box after coating Dry to cure the coating film. Then a suitable drug release hole is prepared on one side of the coating film by laser or mechanical method. Finally, the coated tablet is further coa...

Embodiment 2

[0050] Tablet prescription:

[0051] Levetiracetam 70%

[0052] Polyoxyethylene (molecular weight: 200,000) 21.5%

[0053] Lactose 6.5

[0054] Sodium Carboxymethyl Cellulose 1.0%

[0055] Magnesium Stearate 1.0%

[0056] ethanol, water

[0057] Semipermeable Membrane Prescription:

[0058] Cellulose acetate 75%

[0059] PEG-1500 25%

[0060] Preparation method: mix the prescribed amount of levetiracetam with polyoxyethylene (molecular weight: 200,000) and lactose according to the above ratio, and mix sodium carboxymethylcellulose with 30% ethanol to prepare a compound with a solid content of 2%. Binder, then wet granulation, drying, sieving, adding magnesium stearate and compressing into tablets to make tablet cores. Dissolve cellulose acetate and PEG-1500 in a mixed solution of acetone-water (mass ratio: 95:5), place the tablet core in a coating pan for coating, and place the coated tablet in a dry box after coating Dry to cure the coating film. Then a suitable dru...

Embodiment 3

[0062] Tablet prescription:

[0063] Levetiracetam 69%

[0064] Hypromellose 27.5%

[0065] PVP K30 2.5%

[0066] Magnesium Stearate 1.0%

[0067] ethanol, water

[0068] Semipermeable Membrane Prescription:

[0069] Cellulose acetate 75%

[0070] PEG-1500 25%

[0071] Preparation method: mix the prescribed amount of levetiracetam and hypromellose according to the above ratio, mix PVP K30 and 30% ethanol to prepare a binder with a solid content of 10%, and then wet granulate, Dry, sieve, add magnesium stearate and compress into tablets to make tablet cores. Dissolve cellulose acetate and PEG-1500 in a mixed solution of acetone-water (mass ratio: 95:5), place the tablet core in a coating pan for coating, and place the coated tablet in a dry box after coating Dry to cure the coating film. Then a suitable drug release hole is prepared on one side of the coating film by laser or mechanical method. Finally, the coated tablet is further coated with a non-functional coating...

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Abstract

The invention belongs to the technical field of medicament and provides a Levetiracetam osmotic pump controlled-release tablet and a preparation method thereof. The invention consists of the accessory of the Levetiracetam playing the effect of release control and a semi-transparent membrane; in the invention, proper accessory and medicament are mixed to press a tablet core at first; then a layer of semi-transparent membrane is coated outside the tablet core; then at least one small hole is punched on the semi-transparent membrane so as to lead active matters to be released from the semi-transparent membrane, thereby controlling the release of the medicament. Compared with a common preparation, the controlled-release preparation prepared by the invention has the advantages of small wave range of the blood medicine concentration, reducing toxic and side effect, being taken once in one day and improving the compliance of sufferers. The controlled-release preparation is applied on the adjunctive therapy for the partial seizure of epileptics in clinic.

Description

Technical field: [0001] The invention belongs to the technical field of medicine, and relates to a levetiracetam osmotic pump controlled-release preparation and a preparation method thereof. The preparation can be used for treating partial seizures of epileptic patients. Background technique: [0002] In recent years, controlled-release preparations have increasingly become an important direction for the development of the pharmaceutical industry at home and abroad because of their short development cycle, significant economic benefits, convenient clinical application, and small fluctuations in blood drug concentration. In controlled-release formulations, oral osmotic pumps are ideal. The osmotic pump controlled-release preparation is a drug-release system based on the osmotic pressure difference between the inside and outside of the controlled-release coating film as the drug-release kinetics and zero-order drug-release kinetics as the basic feature. Osmotic pump controlle...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/40A61P25/08
Inventor 王东凯张文涛
Owner SHENYANG PHARMA UNIVERSITY
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