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A kind of pharmaceutical composition and its preparation method and application

A composition and drug technology, applied in the field of biomedicine, can solve the problems of inability to provide, instability, etc., and achieve the effect of improving bioavailability

Active Publication Date: 2022-05-17
SHANGHAI WD PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The technical problem to be solved by the present invention is that the current controlled-release drugs cannot provide a long-term and stable plasma curve of active pharmaceutical ingredients; and cellulose acetate is precipitated in the coating film of the drug, resulting in uneven coating and unstable drug release.

Method used

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  • A kind of pharmaceutical composition and its preparation method and application
  • A kind of pharmaceutical composition and its preparation method and application
  • A kind of pharmaceutical composition and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0135] A dosage form for delivering the beneficial agents levodopa and carbidopa to the oral cavity is manufactured as follows: First, a tablet core is prepared comprising 40.0 wt% levodopa (LD), 10.8 wt% carbidopa monohydrate (CD), 20.0Wt% microcrystalline cellulose, 18.7Wt% mannitol, 5.0Wt% hydroxypropyl methylcellulose (HPMC E5) and 5.0Wt% citric acid, by weight percentage, respectively Pass through a 40-mesh stainless steel sieve, then mix with pure water and granulate until a uniform wet material is formed; the wet material passes through a 20-mesh stainless steel sieve and dry at 80°C for 2 hours; pass the dried granules through a 18-mesh stainless steel sieve, Then mixed with 0.5wt% magnesium stearate.

[0136] Next, using a tablet press, 500 mg of the drug core granules were compressed into a single-layer tablet core with a 9.0 mm round punch.

[0137] Next, wrap the monolayer core with a semipermeable membrane. The film-forming composition comprises 50 wt% cellulose...

Embodiment 2

[0141] A dosage form designed, shaped and adapted to deliver the beneficial drugs levodopa and carbidopa monohydrate to the oral cavity was prepared as follows: First, a drug layer composition was prepared comprising 40.0 wt% LD, 10.8 wt% CD, 31.0Wt% of hydroxypropylcellulose with an average molecular weight of 80,000, 12.7Wt% of mannitol and 5.0Wt% of citric acid, these excipients were sieved through 40 mesh stainless steel, then mixed with 95% ethanol and Granulate until a uniform wet material is formed; the wet material is passed through a 20-mesh stainless steel sieve, and dried at 80° C. for 2 hours; the dried granules are passed through a 18-mesh stainless steel sieve, and then mixed with 0.5 wt % magnesium stearate.

[0142] Next, prepare the second composition, that is, the permeable layer, comprising 55.0Wt% sodium carboxymethylcellulose 7H4XF, 39.0Wt% sorbitol, 5.0Wt% povidone K30 and 0.5Wt% iron oxide red; Stainless steel screen, then mixed with 95% ethanol and gran...

Embodiment 3

[0146] In this example, the steps of Example 2 are repeated, and the dosage form includes the same drug layer, permeation layer and coating film as those provided in Example 2. In this example, the membrane weight gain was 4.0%, and the delivery orifice size changes were 0.5 mm, 0.75 mm, and 1.0 mm. The final manufactured dosage form delivered LD and CD at average rates of 21.3 mg / hr and 5.7 mg / hr, respectively, delivering 85% of LD / CD within 8.0 hours. Such as Figure 5 As shown, the delivery port size had no significant effect on the release profile. The osmotic delivery system can remain in the oral cavity until the osmotic layer reaches the delivery port, or remain there for 4-5 hours before being swallowed.

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Abstract

A pharmaceutical composition, an osmotic pump controlled-release drug delivery system containing the pharmaceutical composition and a preparation method thereof. The pharmaceutical composition comprises a tablet core and a coating film, the tablet core comprises a drug pulling layer, the coating film comprises 50-90% by weight of cellulose acetate and 10-50% by weight of copovidone, and the copolyvidone Ketones are prepared by polymerizing vinylpyrrolidone and vinyl acetate in a molar ratio of 40:60‑80:20.

Description

[0001] This application claims the priority of the Chinese patent application CN201810166976.4 with the filing date of February 28, 2018. This application cites the full text of the above-mentioned Chinese patent application. technical field [0002] The invention relates to the field of biomedicine, in particular to a pharmaceutical composition and its preparation method and application. Background technique [0003] Absorption of a large number of active pharmaceutical ingredients (APIs), including levodopa, baclofen, acyclovir, valacyclovir, ganciclovir, metformin, and gabapentin, is limited to the upper stomach Intestine (upper gastrointestinal tract, UGIT). When these APIs are used in conventional extended release dosages (extended release dosages), their bioavailability is not high, and the effect of prolonged treatment cannot be achieved. Therefore, many techniques have been disclosed in the prior art to prolong their residence time in the stomach, namely: dilation,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K9/44A61K31/198A61K31/137A61K47/38A61K47/32
CPCA61K31/198A61K9/0004A61K9/209A61K9/284A61K9/006A61K2300/00A61K9/2086A61K9/2893A61K31/155A61K31/197A61K31/522A61K47/32
Inventor 董良昶陈溪山
Owner SHANGHAI WD PHARM CO LTD
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