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Tamsulosin hydrochloride sustained-release pellets and preparation method thereof

A technology of tamsulosin hydrochloride and pellets, which is applied in the direction of bulk delivery, urinary system diseases, active ingredients of amides, etc. It can solve the inconvenience of packaging, transportation, storage, low drug release stability, and difficulty in determining the onset time, etc. problems, to achieve the effect of improving bioavailability, small individual differences, and stable therapeutic effect

Inactive Publication Date: 2016-02-03
HARBIN SHENGJI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Difficult to determine time of onset due to slow progression
[0004] At present, among the tamsulosin hydrochloride drugs for the treatment of benign prostatic hyperplasia on the market, there are deficiencies such as low drug release stability, high irritation to the gastrointestinal tract, low bioavailability, inconvenient packaging, transportation, and storage, and complicated preparation methods.

Method used

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  • Tamsulosin hydrochloride sustained-release pellets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A tamsulosin hydrochloride sustained-release pellet, comprising a coating layer and drug-containing pellets; characterized in that: the coating layer is wrapped on the outside of the drug-containing pellets; the coating layer includes: 35-175mg Teqi NE30D, 5-53mg talcum powder; the drug-containing pellets include: 0.2mg tamsulosin hydrochloride, 80mg blank ball core, 200-250mg filler, 10-50mg lubricant, 5-25mg binder.

[0028] The coating layer also includes trace amounts of one or both of sodium lauryl sulfate and polyethylene glycol.

[0029] The preferred weight ratio in the coating layer is: 132mg Eudragit NE30D, 7mg talcum powder.

[0030] The preferred weight ratio of the drug-containing pellets is: 0.2 mg tamsulosin hydrochloride, 80 mg blank pellet core, 240 mg filler, 20 mg lubricant, and 10 mg binder.

[0031] The filler is microcrystalline cellulose, the lubricant is talcum powder, and the binder is hypromellose.

Embodiment 2

[0033] Its production method includes the following steps:

[0034] Step 1: material preparation: according to the above mass ratio, tamsulosin hydrochloride is pulverized with a pulverizer, and passed through a 100-mesh sieve;

[0035] Step 2: Mixing: Take tamsulosin hydrochloride and microcrystalline cellulose according to the above mass ratio and mix them in a three-dimensional mixer for 30 minutes to make a fine powder of the drug, and take it out for later use;

[0036] Step 3: Preparation of adhesive: Weigh an appropriate amount of hypromellose according to the above mass ratio, add an appropriate amount of hot water to prepare an adhesive with a concentration of 2%, and set aside;

[0037] Step 4: Pill making: Put the drug fine powder into the feeding tank of the centrifugal pill making machine, put the adhesive into the liquid supply tank, put the blank pellet core into the centrifugal pill making machine, turn on the machine, adjust the parameters, and start Spray li...

Embodiment 3

[0043] Indications of the present invention: it is suitable for voiding disorder caused by benign prostatic hyperplasia.

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Abstract

The invention discloses tamsulosin hydrochloride sustained-release pellets and a preparation method thereof. The tamsulosin hydrochloride sustained-release pellets comprise a coating layer, medicine-containing pellets, Eudragit NE-30D, powdered steatile, sodium dodecyl sulfate or polyethylene glycol; tamsulosin hydrochloride, blank pellets, a filler, a lubricant and an adhesive. The method employs a novel sustained release preparation and a pellets preparation, slow release means delay of drug release rate of the medicine from a dosage form, absorption rate of medicine in the body can be reduced, more stable treatment effect can be realized; pellets can increase the distribution area of the medicine on the surface of the gastrointestinal tract, irritation is reduced, bioavailability is increased, influence due to stomach evacuation factors is not generated, medicine can be uniformly absorbed in the body, individual difference is little, and simultaneous application of two advanced technologies enhances the technical advantage of the tamsulosin hydrochloride sustained-release pellets.

Description

technical field [0001] The invention belongs to the field of chemical drug sustained-release preparations, and in particular relates to tamsulosin hydrochloride sustained-release pellets and a preparation method thereof. Background technique [0002] Prostatic hyperplasia (BPH) is one of the common diseases of middle-aged and elderly men, and its incidence is increasing with the aging of the global population. The incidence of benign prostatic hyperplasia increases with age, but there may not be clinical symptoms when there are hyperplasia lesions. The urban incidence rate is higher than that in the rural areas, and racial differences also affect the degree of proliferation. [0003] In the early stage of benign prostatic hyperplasia, due to compensation, the symptoms are not typical. With the aggravation of lower urinary tract obstruction, the symptoms gradually become more obvious. The clinical symptoms include storage symptoms, micturition symptoms and post-micturition s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/48A61K31/18A61P13/08
Inventor 马玉国张昕任萃文江延辉马凌风王海涛
Owner HARBIN SHENGJI PHARMA
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