Double layer osmotic pump controlled release felodipine medicine composition

An osmotic pump controlled release and dipine double-layer technology, which is applied in drug combinations, sugar-coated pills, pharmaceutical formulations, etc., can solve the problems of unsatisfactory stability and safety of drug release, inability to release drugs, and reduced drug release speed.

Inactive Publication Date: 2007-03-21
GUANGZHOU PUIS PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since the main release force of the preparation is in the gastrointestinal tract, water enters the tablet core through the semipermeable membrane to form a saturated solution of the drug, and the excipients used as the osmotic agent dissolve, so that there is an osmotic pressure difference between the inside and outside of the membrane.
With the release of the drug and the dissolution of the excipients used as osmotic agents, the drug release rate will decrease with the decrease of the osmotic pressure difference between the inside and outside of the coating film. Always remain constant, so the drug is usually not released completely, the stability of drug release and the safety of drug use are not very ideal

Method used

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  • Double layer osmotic pump controlled release felodipine medicine composition
  • Double layer osmotic pump controlled release felodipine medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] (1) Drug-containing layer

[0078] Felodipine 2.5g

[0079] Polyoxyethylene 50g

[0080] Magnesium stearate 0.5g

[0081] (2) booster layer

[0082] Polyoxyethylene 20g

[0083] Sodium chloride 10g

[0084] Hypromellose 1g

[0085] Iron oxide red 0.2g

[0086] Magnesium stearate 0.3g

[0087] Makes 1000 pieces

[0088] (3) Prescription of coating solution (1000 tablets dosage)

[0089] Cellulose acetate 10g

[0090] Polyethylene glycol 0.5g

[0091] Proper amount of ethanol

[0092] Preparation:

[0093] 1. Sieve, mix and granulate the raw and auxiliary materials of the drug-containing layer and the booster layer according to the above-mentioned prescription amount, and press the drug-containing layer and the booster layer into a double-layer tablet core by two-time tablet compression technology;

[0094] 2. Coating solution preparation: Add cellulose acetate and polyethylene glycol to an appropriate amount of ethanol solution, stir until completely dissolv...

Embodiment 2

[0098] (1) Drug-containing layer

[0099] Felodipine 10g

[0100] Mannitol 4g

[0101] Polyoxyethylene 120g

[0102] Hypromellose 8g

[0103] Magnesium Stearate 1g

[0104] 75% ethanol appropriate amount

[0105] (2) booster layer

[0106] Polyoxyethylene 65g

[0107] Sodium chloride 30g

[0108] Povidone 5g

[0109] Iron oxide red 1g

[0110] Magnesium Stearate 1g

[0111] 75% ethanol appropriate amount

[0112] Makes 1000 pieces

[0113] (3) Prescription of coating solution (1000 tablets dosage)

[0114] Cellulose acetate 20g

[0115] Polyethylene glycol 1g

[0116] Triethyl citrate 2g

[0117] Proper amount of ethanol

[0118] Preparation:

[0119] 1. Sieve and mix the raw and auxiliary materials of the drug-containing layer and the booster layer according to the above-mentioned prescription amount, respectively, and mix wet granulation, and use the two-time compression technology to compress the drug-containing layer and the booster layer into a double-lay...

Embodiment 3

[0122] (1) Drug-containing layer

[0123] Felodipine 10g

[0124] Sodium chloride 4g

[0125] Polyoxyethylene 130g

[0126] Hypromellose 9g

[0127] Magnesium Stearate 1g

[0128] (2) booster layer

[0129] Polyoxyethylene 70g

[0130] Sodium chloride 30g

[0131] Hypromellose 5.5g

[0132] Iron oxide red 1g

[0133] Magnesium stearate 0.5g

[0134] Makes 1000 pieces

[0135] (3) Prescription of coating solution (1000 tablets dosage)

[0136] Cellulose acetate 60g

[0137] Polyethylene glycol 3g

[0138] Proper amount of ethanol

[0139] Proper amount of acetone

[0140] The preparation method is the same as in Example 1.

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Abstract

The double layer osmotic pump controlled release felodipine medicine composition includes double layer core and coating film. The double layer core contains felodipine and pharmaceutically acceptable excipient; and the coating film is semi-permeating film with or without pore creating agent. The double layer osmotic pump controlled release felodipine medicine composition of the present invention can control the release of medicine in some specific time period, has reduced medicine taking times, smooth in vivo blood medicine concentration and radically raised medicine safety and effectiveness.

Description

technical field [0001] The invention relates to a controlled-release pharmaceutical preparation, in particular to a double-layer osmotic pump controlled-release pharmaceutical composition of an antihypertensive drug felodipine and a preparation method thereof. Background technique [0002] Felodipine is a vascular selective dihydropyridine calcium ion antagonist, which is suitable for the treatment of various stages of hypertension without affecting cardiac function. Observations showed that regression of left ventricular hypertrophy was associated with felodipine treatment. Felodipine is also suitable for the treatment of hypertensive patients with diabetes, renal insufficiency or asthma. The antihypertensive range and effective rate are better than hydrochlorothiazide, propranolol and prazosin. It can replace the traditional triple therapy (diuretic + beta blocker + hydralazine) in combination with beta blockers; it can also reduce renal vascular resistance, increase ren...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K47/38A61K9/28A61P9/12
Inventor 贝庆生
Owner GUANGZHOU PUIS PHARMA FACTORY
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