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Almotriptan-containing buccal adhesive tablet as well as preparation method and application thereof

An oral adhesion and adhesive technology, which is used in pill delivery, nervous system diseases, drug combinations, etc., can solve the problems of poor oral administration route, reduced oral drug absorption, and low bioavailability, etc., to avoid Liver first-pass effect, reduction in incidence, avoidance of gastrointestinal effects

Inactive Publication Date: 2011-06-29
QINGDAO HUANGHAI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Almotriptan is easy to use and has good patient compliance and tolerance, but the common symptoms of migraine attacks in gastrointestinal disorders are mainly nausea and vomiting, even if there is no nausea symptom, it may cause Delayed gastric emptying and decreased oral drug absorption, low bioavailability, showing that the oral route of administration is not effective; moreover, since the onset of the disease varies from person to person and from time to time, patients need more treatment options offer options

Method used

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  • Almotriptan-containing buccal adhesive tablet as well as preparation method and application thereof
  • Almotriptan-containing buccal adhesive tablet as well as preparation method and application thereof
  • Almotriptan-containing buccal adhesive tablet as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Oral Adhesive Tablets of Almotriptan (1000 Tablets)

[0025] Almotriptan 6.25g

[0026] Carbomer 934 15g

[0027] Hydroxypropyl cellulose 47g

[0028] Lactose 11g

[0029] Magnesium stearate 0.8g

[0030] Ethyl cellulose 5g

[0031] Polyethylene glycol 6000 0.5g

[0032] Copovidone 0.4g

[0033] Lemon yellow 2mg

[0034] The preparation method is as follows:

[0035] After mixing almotriptan, carbomer 934, hydroxypropyl cellulose, lactose, and magnesium stearate, pass through an 80-mesh sieve, and directly press tablets with a 6mm diameter tablet press. Polyethylene glycol 6000, copovidone, and lemon yellow are dissolved in 100ml of 95% ethanol solution, and sprayed evenly on one side of the adhesive part containing the drug with a spray film machine. After drying at 35~40℃, it forms waterproof protection section.

Embodiment 2

[0037] Oral Adhesive Tablets of Almotriptan (1000 Tablets)

[0038] Almotriptan 6.25g

[0039] Carbomer 934P 10g

[0040] Hypromellose 43g

[0041] Mannitol 20g

[0042] Magnesium stearate 0.5g

[0043] Cellulose acetate 8g

[0044] Polyethylene glycol 4000 1g

[0045] Copovidone 0.8g

[0046] Lemon yellow 2mg

[0047] The preparation method is as follows:

[0048] After mixing Almotriptan, Carbomer 934P, Hypromellose, Mannitol, and Magnesium Stearate, pass through a 90-mesh sieve. Use a tablet press with a diameter of 7mm. Polyethylene glycol 4000, copovidone, and lemon yellow are dissolved in 100ml of acetone: water (95%: 5%) solution, and spray evenly on one side surface of the adhesive part containing the drug with a spray film machine. After drying, a waterproof protective part is formed.

Embodiment 3

[0050] Oral Adhesive Tablets of Almotriptan (1000 Tablets)

[0051] Almotriptan 6.25g

[0052] Carbomer 934 14g

[0053] Sodium carboxymethyl cellulose 45g

[0054] Mannitol 14g

[0055] Micro powder silica gel 0.5g

[0056] Ethyl cellulose 5g

[0057] Diethyl phthalate 1g

[0058] Copovidone 0.8g

[0059] Erythrosine 2mg

[0060] The preparation method is as follows:

[0061] After mixing Almotriptan, Carbomer 934, Sodium Carboxymethyl Cellulose, Mannitol, and Micronized Silica Gel, Pass through an 80-mesh sieve, and directly press tablets with a 6mm diameter tablet press. Dissolve the vitamins, diethyl phthalate, copovidone, and erythrosine with 100ml of 95% ethanol solution, spray them evenly on the side surface of the drug-containing adhesion part with a spray film machine, and dry at 35-40°C to form Waterproof protection part.

[0062] According to the dissolution test method (Chinese Pharmacopoeia 2010 edition two appendix XD method three), the samples prepared in the above examples ar...

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Abstract

The invention provides an almotriptan-containing buccal adhesive tablet. The tablet consists of a medicine-containing adhesive part and a waterproof protection part, wherein the medicine-containing adhesive part comprises the following components in percentage by weight: 1 to 30 percent of almotriptan, 12 to 85 percent of adhesive agent, and 5 to 30 percent of excipient; and the waterproof protection part comprises the following components in percentage by weight: 1 to 15 percent of film-forming agent, 0.1 to 10 percent of plasticizer, and 0.001 to 3 percent of pigment. The invention also provides a method for preparing the almotriptan-containing buccal adhesive tablet. The medicine-containing adhesive part of the buccal adhesive tablet is in directly contact with an oral mucosa, and the medicament is directly absorbed to enter systemic circulation through the oral mucosa, thus the influence on gastrointestinal tract and pass effect of liver are avoided, and the occurrence of adverse reaction is reduced. Furthermore, the buccal adhesive tablet provided by the invention can be adhered to the oral mucosa for a long time, so that stable blood concentration is maintained, and the bioavailability is improved.

Description

Technical field [0001] The invention relates to a medicine for treating migraine, in particular to an oral adhesive tablet containing amotriptan and a preparation method thereof. Background technique [0002] Migraine is one of the common diseases in neurology, with an incidence of more than 10% of the population. The International Headache Association defines migraine as intermittent headache attacks accompanied by autonomic disorders. The clinical manifestation is paroxysmal headache, often accompanied by dizziness and hearing loss. The male to female ratio of migraine incidence is 1:4, which mostly occurs in young and middle-aged people between 25 and 55 years old. With the acceleration of the pace of life and the increase of work pressure, the incidence of migraine is on the rise. Whether in developed or developing countries, it has become a common and frequently-occurring disease that plagues people. Migraine seriously affects the patient's quality of life and work effici...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4045A61P25/06
Inventor 王芳曹瑞山李振霞牛佰慧徐晓琳马德宝陈颖
Owner QINGDAO HUANGHAI PHARM CO LTD
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