Controlled release tablet and preparation method thereof

A technology for controlled-release tablets and tablet cores, which can be used in the delivery of pills, pharmaceutical formulations, and medical preparations with inactive ingredients. , the effect of reducing the risk of intestinal obstruction

Pending Publication Date: 2022-02-18
SHANGHAI WD PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0026] The technical problem to be solved by the present invention is to overcome the proportion of API in the drug-containing layer <25wt% in the existing controlled-release tablets (such as nifedipine controlled-release tablets), and the size of the controlled-release tablets is large, which is difficult for patients with intestinal strictures. There is the defect of the risk of intestinal obstruction, and a kind of controlled-release tablet and preparation method thereof are provided

Method used

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  • Controlled release tablet and preparation method thereof
  • Controlled release tablet and preparation method thereof
  • Controlled release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0231] The prescription is as follows:

[0232]

[0233]

[0234] Preparation:

[0235] 1. Preparation of the drug-containing layer: avoid light. Pre-mix nifedipine with other excipients (except magnesium stearate) in the drug-containing layer, add it to a dry granulator and press it into a ribbon, pass through a 16-mesh stainless steel screen to granulate, and finally add magnesium stearate to mix ,spare.

[0236] 2. Preparation of the booster layer: Pre-mix the auxiliary materials of the booster layer (except magnesium stearate), add them into a dry granulator and press them into strips, pass through a 16-mesh stainless steel screen for granulation, and finally add extra stearin Magnesium acid mixed, set aside.

[0237] 3. Tablet compression: keep away from light. Use a double-layer tablet press machine to compress the double-layer tablet, the die size is 6mm round tablet, first fill 82.5mg of drug-containing layer material, pre-press, then fill 41.3mg of booster l...

Embodiment 2

[0241] The prescription is as follows:

[0242]

[0243]

[0244] Preparation method: The preparation method of the double-layer tablet core is the same as in Example 1, and the weight of each double-layer tablet core is 123.8 mg. A coating pan was used to coat the double-layer tablet cores with the above-mentioned controlled-release coating solution to a weight gain of 15.3 wt% and 18.1 wt%, and a drug release pore size of 0.5 mm. The release measurement method is the same as in Example 1. The specification of the controlled-release tablet in this embodiment is 30 mg / tablet, a round tablet with a diameter of 6 mm. figure 2 Be the nifedipine controlled-release tablet release curve in embodiment 2. Not broken.

Embodiment 3

[0256] The prescription is as follows:

[0257]

[0258] Preparation method: The preparation method of the double-layer tablet core is the same as that in Example 1. The weight of each double-layer tablet core is 165 mg, and the weight of the booster layer is 55.0 mg / tablet. A coating pan is used to coat the double-layer tablet core with the above-mentioned controlled-release coating solution, the weight gain of the coating is 15.0%, and the drug release aperture is 0.5mm. The release measurement method is the same as in Example 1. The specification of the controlled-release tablet in this embodiment is 30mg / tablet, and the circular tablet has a diameter of 7mm. The observation chart of whether the controlled-release membrane is broken during the release process can be found in Figure 24 .

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Abstract

The invention provides a controlled release tablet and a preparation method thereof. The controlled release tablet comprises a tablet core and a coating wrapping the tablet core, the tablet core comprises a drug-containing layer and a boosting layer compounded on the drug-containing layer, the coating is provided with drug release holes on one side of the drug-containing layer, and the coating is a semi-permeable film; the raw materials of the drug-containing layer comprise raw material medicines and auxiliary materials; in the drug-containing layer, the weight of the raw material medicines is 25.0-50.0wt% of the weight of the drug-containing layer; in the drug-containing layer, the raw materials of the auxiliary materials comprise one or more of poloxamer, lauryl sodium sulfate, polyoxyl stearate and vitamin E polyethylene glycol succinate, and the weight of the components accounts for 0.0-10.0wt% of the weight of the drug-containing layer. The proportion of the controlled release tablet API in the drug-containing layer is larger than or equal to 25wt%, the weight and size of the controlled release tablet are reduced, a small-size controlled release tablet can be prepared, the swallowing compliance of a patient is improved, and the risk of intestinal obstruction in vivo is reduced.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a controlled-release tablet and a preparation method thereof. Background technique [0002] Nifedipine was first developed and marketed by German Bayer Company in the 1970s. After years of clinical application and in-depth research, nifedipine has become one of the first-selected drugs for the clinical treatment of hypertension and angina pectoris. Nifedipine has strong photosensitivity and is easily degraded when exposed to light. Common preparations of nifedipine reflexively cause increased heart rate, activation of the sympathetic nervous system, adverse reactions such as unfavorable control of myocardial ischemia and heart failure, and require frequent administration, making it difficult to meet the medication needs of patients. Therefore, the common preparations of nifedipine have been phased out internationally and replaced by long-acting sustained-rele...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K9/44A61K9/36A61K47/38A61K47/10A61K47/26A61K47/12A61K47/02A61K47/36A61K31/4422A61K31/519A61P9/12A61P9/10
CPCA61K9/2072A61K9/209A61K9/2095A61K9/2054A61K9/2031A61K9/2018A61K9/2013A61K9/2009A61K9/2866A61K9/205A61K31/4422A61K31/519A61P9/12A61P9/10
Inventor 董良昶陈溪山郝佳宁焦艳张丹勇郑钊铖
Owner SHANGHAI WD PHARM CO LTD
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