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Diltiazem hydrochloride sustained-release capsule

A technology for diltiazem hydrochloride and capsules, applied in the field of medicine, can solve the problems of complex operation process, unqualified, and high requirements for pharmaceutical equipment, and achieve the effects of stable drug release, simple preparation process and controllable quality.

Pending Publication Date: 2022-05-03
NOVAST LABORATORIES (CHINA) LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this commercially available preparation contains two types of pellets with different drug release behaviors, the operation process is complicated, the requirements for pharmaceutical equipment are high, the cost of product quality consistency control is high, and unqualified products are prone to appear in the production process
[0006] Not yet seen with the commercially available formulation Cardizem Relevant literature reports on diltiazem sustained-release pellets and capsules with bioequivalent but simple preparation process and controllable product quality

Method used

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  • Diltiazem hydrochloride sustained-release capsule
  • Diltiazem hydrochloride sustained-release capsule
  • Diltiazem hydrochloride sustained-release capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] Embodiment 1, extrusion spheronization method prepares quick-release pellet part

[0070] 1. Prescription

[0071] components use F1(%w / w) diltiazem hydrochloride Main drug 71.8 Plasdone K-29 / 32 Adhesive 3.0 Microcrystalline Cellulose PH101 filler 13.0 Tween 80 D 1.5 fumaric acid Acidifier 10.7 water solvent Appropriate amount (volatile during drying) total / 100.0

[0072] 2. Preparation method

[0073] Weigh each component of the prescription amount, fully mix diltiazem hydrochloride, microcrystalline cellulose PH101, and fumaric acid, and use an aqueous solution containing Plasdone K-29 / 32 and Tween 80 to carry out wet granulation, and the obtained wet granules are Prepare pellets by extrusion and spheronization, then put the wet pellets into a fluidized bed to dry, and sieve the dried pellets to remove larger aggregates on the sieve and fine powder under the sieve to obtain the product.

Embodiment 2

[0074] Embodiment 2, fluidized bed medicine method prepares quick-release pellet part

[0075] 1. Prescription

[0076]

[0077] 2. Preparation method:

[0078] Weigh each component of the prescription amount, dissolve diltiazem hydrochloride, Plasdone K-29 / 32 or HPC (Klucel EXF) and Tween 80 in water to prepare a drug solution, and the drug solution passes through the spray gun system under the effect of atomizing air Coated on the surface of the fluidized sucrose core to form a drug layer. After the drug solution is sprayed, the fumaric acid solution is continuously sprayed into the fluidized bed, and a fumaric acid layer is coated on the surface of the drug layer. Sieve the dried pellets to remove larger aggregates on the sieve and fine powder under the sieve to obtain the product.

Embodiment 3

[0079] Embodiment 3, the coating method of the present invention prepares sustained-release pellet capsule

[0080] 1. Prescription

[0081]

[0082]

[0083] 2. Preparation method

[0084] The sustained-release coating layer suspension is coated on the surface of the fluidized drug-containing immediate-release pellets through a spray gun system under the action of atomized air to form a sustained-release coating layer. Sieve the dried sustained-release pellets to remove larger aggregates on the sieve and fine powder under the sieve. The obtained sustained-release pellets are mixed with talcum powder for lubrication, filled into capsules, and obtained.

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Abstract

The invention relates to a diltiazem hydrochloride sustained-release pellet capsule, a sustained-release pellet in the sustained-release pellet capsule comprises a drug-containing quick-release pellet and a sustained-release coating layer, and the sustained-release coating layer comprises a mixture of a quaternary amine methacrylate copolymer type A and a quaternary amine methacrylate copolymer type B which are used as sustained-release materials, the quaternary amine methacrylate copolymer A accounts for not more than 12% of the total weight of the quaternary amine methacrylate copolymer. By optimizing the composition of the sustained-release coating material of the pellet, the sustained-release preparation with pulse release effect and stable drug release is obtained, the preparation has bioequivalence with commercially available preparations, the preparation process is simple, the quality is controllable, and the sustained-release preparation is suitable for large-scale industrial production.

Description

technical field [0001] The invention belongs to the field of medicines, in particular to a diltiazem hydrochloride sustained-release capsule. Background technique [0002] Diltiazem (Diltiazem), also known as diltiazem, is a highly selective calcium antagonist, which was first successfully developed by the United States and Japan in 1974, and is mainly used clinically to treat coronary heart disease, angina pectoris, and hypertension. The half-life of diltiazem is short, and the slow-release preparation can reduce the frequency of taking medicine and the fluctuation of blood drug concentration, and reduce side effects. [0003] Chronopharmacological studies have found that some diseases such as cardiovascular disease, asthma, gastric acid secretion, arthritis, etc. have a circadian rhythm in the onset, such as hypertension, angina pectoris, myocardial infarction, morning stiffness, and stroke often occur in the early morning. In order to effectively prevent and treat these ...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/554A61K47/32A61K47/38A61K47/26A61P9/10A61P9/12
CPCA61K9/5026A61K31/554A61K47/38A61K47/26A61P9/10A61P9/12
Inventor 龚健徐彦瞿艳丽钱云飞
Owner NOVAST LABORATORIES (CHINA) LTD
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