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Pharmaceutical composition containing vardenafil hydrochloride, orally disintegrating tablet and preparation and application thereof

A technology of vardenafil hydrochloride and vardenafil, which is applied in the direction of drug combination, medical preparation of non-active ingredients, drug delivery, etc. It can solve the problem of poor uniformity of drug content, long disintegration time of orally disintegrating tablets, etc. problem, to achieve good drug content uniformity and reduce energy consumption

Active Publication Date: 2021-02-02
江西杏林白马药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] The technical problem to be solved by the present invention is to overcome the defects of long disintegration time and poor drug content uniformity of existing orally disintegrating tablets, and to provide a hydrochloric acid valerian with shorter disintegration time and better drug content uniformity. Denafil pharmaceutical composition, orally disintegrating tablet and its preparation and application

Method used

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  • Pharmaceutical composition containing vardenafil hydrochloride, orally disintegrating tablet and preparation and application thereof
  • Pharmaceutical composition containing vardenafil hydrochloride, orally disintegrating tablet and preparation and application thereof
  • Pharmaceutical composition containing vardenafil hydrochloride, orally disintegrating tablet and preparation and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080]

[0081]

[0082] Preparation:

[0083] Pass vardenafil hydrochloride trihydrate through a 80-mesh sieve, mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, fructose, essence, and sucralose all pass through a 60-mesh sieve, magnesium stearate, colloidal Silica is passed through a 30-mesh sieve for subsequent use. Take microcrystalline cellulose, vardenafil hydrochloride trihydrate (its D 90 The particle size is 45 μm), sucralose, fructose, essence, placed in a V-type mixer or a universal mixer for pre-mixing for 5 minutes. Then add the prescribed amount of low-substituted hydroxypropyl cellulose and mannitol in turn and mix for 15 minutes. Put the material in the hopper of a dry granulator and granulate, transfer the prepared granules to a mixer, add the prescribed amount of colloidal silicon dioxide and magnesium stearate and mix for 3 minutes. After mixing evenly, press into tablets, and the prepared tablets are not coated. Among ...

Embodiment 2

[0085]

[0086] Preparation:

[0087] Pass vardenafil hydrochloride through a 80-mesh sieve, microcrystalline cellulose, sorbitol, xylitol, crospovidone, aspartame, and flavors through a 60-mesh sieve, and magnesium lauryl sulfate through a 30-mesh sieve Sieve and set aside. Weigh 1 / 2 microcrystalline cellulose, xylitol, vardenafil hydrochloride (its D 90 The particle size is 105 μm), aspartame, essence, and cross-linked povidone, and pre-mixed in a V-type mixer or a universal mixer for 5 minutes. Then add the remaining 1 / 2 of the prescription amount of microcrystalline cellulose and sorbitol and mix for 15 minutes. Add the prescribed amount of magnesium lauryl sulfate and mix for 3 minutes. After mixing evenly, it is directly pressed into tablets, and the prepared tablets are not coated. Wherein, the tabletting parameters are consistent with that of Example 1, with a shallow concave circular punch. Test this tablet according to described test method, the results are s...

Embodiment 3

[0089]

[0090] Preparation:

[0091] Pass vardenafil hydrochloride trihydrate through a 80-mesh sieve, microcrystalline cellulose, anhydrous calcium hydrogen phosphate, crospovidone, sorbitol, xylitol, and essence all pass through a 60-mesh sieve, and magnesium stearate pass through a 60-mesh sieve. 30 mesh sieve for use. Sorbitol, vardenafil hydrochloride trihydrate (its D 90 The particle size is 45 μm), xylitol, essence, crospovidone, anhydrous calcium hydrogen phosphate, pre-mixed in a V-type mixer or a universal mixer for 5 minutes. Then add the prescribed amount of microcrystalline cellulose and mix for 15 minutes. Put the material in the dry granulator hopper for granulation, transfer the obtained granules to the mixer, add the prescribed amount of magnesium stearate and mix for 3 minutes. After mixing evenly, press into tablets, and the prepared tablets are not coated. Among them, the parameters of dry granulation and tabletting are consistent with those of Exam...

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Abstract

The invention discloses a pharmaceutical composition containing vardenafil hydrochloride, an orally disintegrating tablet and its preparation and application. The pharmaceutical composition includes an active ingredient, a filler and a disintegrant, wherein the active ingredient is vardenafil hydrochloride or vardenafil hydrochloride trihydrate, and the D of the active ingredient 90 The particle size is 45‑180 μm. The pharmaceutical composition is prepared by using conventional auxiliary materials in the field, without special auxiliary materials and equipment, and large-scale production can be realized with existing equipment and auxiliary materials. The orally disintegrating tablet containing the pharmaceutical composition has better drug content uniformity, stability consistent with that of a control drug, moderate hardness, rapid disintegration in the oral cavity, and good taste when taken.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing vardenafil hydrochloride, an orally disintegrating tablet and its preparation and application. Background technique [0002] Oral Disintegrating Tablets (ODT, hereinafter referred to as Oral Disintegrating Tablets) have significant features and advantages compared with ordinary tablets. Its two biggest advantages are: ①Easy to take, because orally disintegrating tablets do not need to be taken with water, nor chewed and swallowed, they can quickly disintegrate or dissolve in the oral cavity to exert their medicinal effects. Therefore, it is especially suitable for the elderly, young children, outdoor workers, people with chewing / swallowing disorders or other special populations (psychiatric patients or epilepsy patients in the onset state, etc.). ② Absorption is fast. Due to the rapid disintegration or dissolution in the oral cavity, in addition to some drugs entering the gastrointestina...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/53A61K47/26A61K47/38A61K47/32A61P15/10
CPCA61K9/0056A61K9/2018A61K9/2027A61K9/2054A61K31/53
Inventor 马春兰张清华万常影朱勤约翰·卡特
Owner 江西杏林白马药业股份有限公司
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