Unlock instant, AI-driven research and patent intelligence for your innovation.

A kind of tadalafil tablet composition

A technology of dalafil tablets and tadalafil, which is applied in the directions of drug combination, pill delivery, medical preparations of inactive ingredients, etc., can solve the problems of unreasonable dosage and low industrial production efficiency, etc.

Active Publication Date: 2021-09-10
DISHA PHARMA GRP
View PDF10 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Chinese patent CN104188912B dissolves tadalafil and carrier materials (polyvinylpyrrolidone K30, poloxamer) in absolute ethanol, and then spin-evaporates under reduced pressure at 50-90°C to obtain a solid dispersion, but this method involves organic solvents There are still some safety issues in the use and detection of solvent residues, and the industrial production efficiency is low
[0005] Chinese patent CN107303284A mixes tadalafil and sodium lauryl sulfate and then pulverizes it. The amount used in this patent (4 times the amount of raw materials) is much higher than that used in the original patent CN1213754C (between 0.25 and 1.25 times the amount of raw materials) ), the dosage is unreasonable

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • A kind of tadalafil tablet composition
  • A kind of tadalafil tablet composition
  • A kind of tadalafil tablet composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Tadalafil 200g, lactose 2320g, microcrystalline cellulose 500g, croscarmellose sodium 220g, polyethylene glycol 6000 7g, hydroxypropyl cellulose 30g, sodium lauryl sulfate 9g, stearic acid Magnesium 24g, Opadry 100g. According to the preparation method described in the technical scheme, 1000 tablets were prepared, wherein the prescribed amount of tadalafil was uniformly mixed with the prescribed amount of polyethylene glycol and 400g of lactose, and were pulverized together. The D90 of the resulting mixture was measured to be 37.2 microns, and the Carr index was 17.9. . The Carr index was calculated by measuring the tap density meter.

Embodiment 2

[0025] Tadalafil 200g, Lactose 2480g, Microcrystalline Cellulose 540g, Croscarmellose Sodium 230g, Macrogol 6000 10g, Hydroxypropyl Cellulose 38g, Sodium Lauryl Sulfate 10g, Stearic Acid Magnesium 28g, Opadry 100g. According to the preparation method described in the technical scheme, 1000 tablets were prepared, wherein the prescribed amount of tadalafil was mixed with the prescribed amount of polyethylene glycol and 600g of lactose, and were pulverized together. The D90 of the resulting mixture was measured to be 24.5 microns, and the Carr index was 17.6. .

Embodiment 3

[0027] Tadalafil 200g, lactose 2400g, microcrystalline cellulose 520g, croscarmellose sodium 225g, polyethylene glycol 6000 8g, hydroxypropyl cellulose 35g, sodium lauryl sulfate 9.5g, stearin Magnesium acid 25g, Opadry 100g. According to the preparation method described in the technical scheme, 1000 tablets were prepared, wherein the prescribed amount of tadalafil was uniformly mixed with the prescribed amount of polyethylene glycol and 500g of lactose, and were pulverized together. The D90 of the resulting mixture was measured to be 26.7 microns, and the Carr index was 17.7. .

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
Carr indexaaaaaaaaaa
Carr indexaaaaaaaaaa
Carr indexaaaaaaaaaa
Login to View More

Abstract

The invention relates to a tadalafil tablet composition and a preparation method, belonging to the technical field of pharmacy. The technical scheme of the present invention is: a kind of tadalafil tablet composition, in every thousand tablets, contain tadalafil 200g, lactose 2320-2480g, microcrystalline cellulose 500-540g, croscarmellose Sodium 220‑230g, Macrogol 6000 7‑10g, Hydroxypropyl Cellulose 30‑38g, Sodium Lauryl Sulfate 9‑10g, Magnesium Stearate 24‑28g, Opadry 100g. The invention provides a high-quality tadalafil tablet for clinical use.

Description

technical field [0001] The invention relates to a tadalafil tablet composition and a preparation method, belonging to the technical field of pharmacy. Background technique [0002] Tadalafil was developed by Eli Lilly and Company for the treatment of erectile dysfunction in men. Tadalafil is a poorly soluble drug, and the commercially available dosage form is tablet. [0003] The Chinese patent CN1213754C of the original research adopts the raw material micronization process, and the particle size of the tadalafil raw material drug is D 90 It is controlled below 40 μm to improve the solubility, but since the fluidity of the tadalafil bulk drug becomes poor after pulverization, it adopts a wet granulation process to prepare tablets, and the disclosed tablet-making process takes a long time. During the preparation of tablets, we found that the prepared tablets had the problem of large dissolution differences within batches. [0004] Chinese patent CN104188912B dissolves tad...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/14A61K47/26A61K47/10A61K31/4985A61P15/10
CPCA61K9/145A61K9/146A61K9/2095A61K31/4985A61P15/10
Inventor 薛颖娜吴成杨田鹏倩
Owner DISHA PHARMA GRP