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Dextrorotatory oxiracetam oral dispersing membrane and preparation method thereof

A technology of dextrooxypyridine and dispersing film, which is applied in the field of dextrooxypyridine pharmaceutical composition, can solve the problems of low drug loading, restrictions on the development and application of orodispersible films, disintegration time and resistance Tension strength is difficult to control and other problems, to achieve the effect of simple preparation method, improve bioavailability, and avoid elimination effect

Inactive Publication Date: 2018-11-13
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although orodispersible films have many advantages, the limitations of film-forming materials and preparation technology lead to low drug loading, disintegration time and tensile strength are not easy to control, which restricts the development and application of orodispersible films

Method used

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  • Dextrorotatory oxiracetam oral dispersing membrane and preparation method thereof
  • Dextrorotatory oxiracetam oral dispersing membrane and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Prescription: 65g of dextrooxypyridine, filler (5g of pregelatinized starch), film-forming material (14g of polyvinyl alcohol, 7g of hydroxypropyl methylcellulose), plasticizer (4g of propylene glycol, phthalate Dibutyl formate 4g), flavoring agent (aspartame 1g).

[0032] Preparation:

[0033] 1) Dissolve the film-forming materials (PVA and hydroxypropyl methylcellulose) with 80mL deionized water, and remove the air bubbles to obtain a uniform viscous liquid;

[0034] 2) Disperse propylene glycol, dibutyl phthalate, aspartame, and pregelatinized starch with 60mL of absolute ethanol to form a dispersion;

[0035] 3) Add the dispersion liquid in step 2) to the viscous liquid in step 1), and add dextrooxypyridine to disperse evenly, and then let it stand to remove air bubbles;

[0036] 4) Coat the viscous liquid after removing air bubbles with a drug film coating dryer at a coating speed of 65cm / min, then dry at about 75°C, and peel off.

Embodiment 2

[0038] Prescription: D-hydroxypyridamine 55g, polyvinyl alcohol 18g, hydroxypropyl methylcellulose 18g, propylene glycol 2g, dibutyl phthalate 6g, xylitol 1g.

[0039] Preparation:

[0040] 1) Dissolve the film-forming materials (PVA and hydroxypropyl methylcellulose) with 70mL deionized water, and remove the air bubbles to obtain a uniform viscous liquid;

[0041] 2) Disperse propylene glycol, xylitol, and dibutyl phthalate with 50 mL of absolute ethanol to form a dispersion;

[0042] 3) Add the dispersion liquid in step 2) to the viscous liquid in step 1), and add dextrooxypyridine to disperse evenly, and then let it stand to remove air bubbles;

[0043] 4) Coat the viscous liquid after removing air bubbles with a drug film coating dryer at a coating speed of 50cm / min, then dry at about 65°C, and peel off.

Embodiment 3

[0045] Prescription: 52g of dextropyridine, 8g of microcrystalline cellulose, 15g of polyvinyl alcohol, 10g of sodium carboxymethylcellulose, 5g of pullulan, 6g of glycerin, 3g of triethyl citrate, 1g of sucralose .

[0046] Preparation:

[0047] 1) Dissolve polyvinyl alcohol, sodium carboxymethyl cellulose, and pullulan in 100 mL of deionized water, and remove air bubbles to obtain a uniform viscous liquid;

[0048] 2) Disperse glycerin, microcrystalline cellulose, sucralose, and triethyl citrate with 50mL of absolute ethanol to form a dispersion;

[0049] 3) Add the dispersion liquid in step 2) to the viscous liquid in step 1), and add dextrooxypyridine to disperse evenly, and then let it stand to remove air bubbles;

[0050] 4) Coat the viscous liquid after removing air bubbles with a drug film coating dryer at a coating speed of 80cm / min, then dry at about 85°C, and peel off.

[0051] Referring to the preparation method of Example 1, run Examples 4-17 according to the p...

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Abstract

The invention provides a dextrorotatory oxiracetam oral dispersing membrane which is prepared from a PVA-containing membrane forming material together with specific adjuvant materials such as a plasticizer, a filler and a corrigent by a coating method. The dextrorotatory oxiracetam oral dispersing membrane can be dissolved in the mouth with a small amount of saliva and can be taken without water,which brings convenience in use. As the dextrorotatory oxiracetam oral dispersing membrane is not easy to spit when being adhered to the tongue, it is suitable for patients having dysphagia. As the membrane is absorbed through oral mucosa, the first pass elimination effect is eliminated, bioavailability is improved, applying dosage is reduced, and further the side effect of drug is reduced. The preparation method is simple, can be implemented without large-size industrial equipment, and is suitable for industrial production.

Description

technical field [0001] The invention relates to a dextrooxypyridine pharmaceutical composition, in particular to a dextrooxypyridine oral dispersible film and a preparation method thereof. Background technique [0002] Epilepsy is a chronic disease in which the sudden abnormal discharge of brain neurons leads to transient brain dysfunction. Epileptic seizure refers to the clinical phenomenon caused by abnormal and excessive supersynchronized discharge of brain neurons. Transient symptoms vary depending on where in the brain the abnormally firing neurons are located and can be motor-sensory-mental or autonomic with or without changes in consciousness or alertness. Studies have shown that D-hydroxypyridine (CAS No.: 68252-28-8) can promote the transport of acetylcholine in the cerebral cortex and hippocampus, increase the affinity for choline uptake and the activity of brain phosphatase A1, and play a role in epilepsy. , especially in acute epileptic seizures, has good activi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/4015A61K47/32A61P25/08
CPCA61K9/0056A61K9/7007A61K31/4015A61K47/32
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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