Pharmaceutical composition having an analgesic effect

 

(57) Abstract:

The invention can be used in medicine for pain of moderate intensity. The pharmaceutical composition is enclosed within a hard gelatin capsule. The composition is an effective amount of tramadol hydrochloride and these additives target. The number of target components in % of tramadol hydrochloride : calcium phosphate dihydrate 27,9-34,1; lactose or microcrystalline cellulose 160,3-195,9; stearate and/or calcium 0,8-1,1; Aerosil 0-5,5. The invention allows to obtain a dosage form of tramadol capsules. The composition has a consistency, improved raspadaemost and solubility of the relevant regulatory requirements.

The invention relates to medicine, specifically to medicines, analgesic effect.

In recent years, widespread in medical practice as a strong Central analgesic actions received tramadol, successfully reducing pain syndrome of moderate intensity in malignant tumors, acute myocardial infarction, trauma, diagnostic and therapeutic procedures, neuropathy, inhaled forms (U.S. patent N 3652589, 1972 ), includes:

dosage form in the form of granules or paste:

Active substance - 50 g

Starch - 338 g

Lactose - 144 g

Sodium benzoate - 5 g

dosage form in tablet form:

Active substance 50 mg

Starch - a 20 g

Magnesium stearate 1 g

Talc - 9 g

preparation in the form of inhaled form:

Active ingredient 25 mg

Pentobarbital sodium 30 mg

Ethoxybenzene 250 mg

Acetamidophenol 250 mg

Dosage forms for vnutripuzarnogo and/or inhalation are described in international application WO 97/17948, 1997

The invention provides the following compounds:

for vnutripuzarnogo applications:

Tramadol hydrochloride, 20 g

Methyl cellulose 300 mg

Tween - 80 to 30 grams

Purified water - 100 ml

for inhalation, wt.%:

Aerosol lactose - 78,8 - 79

Sorbitol - 0,0 - 0,4

Tramadol hydrochloride - 1,0

Lactose - 19,8

It is known (encyclopedia of medicine), radar 2000, S. 919), which, along with other dosage forms of tramadol hydrochloride is used in the form of capsules containing the basic substance 0.05 g, but information on pharmacy is I create a pharmaceutical composition, analgesic action, made in the form of hard gelatin capsules, which satisfies all of the requirements of the current Gosfarmakapei XI ed.

This is achieved by a pharmaceutical composition comprising as active ingredient an effective amount of tramadol hydrochloride and targeted supplements, providing flowability, nasleduemoe, the stability of the contents of the capsules.

As the target additives used calcium phosphate dihydrate, lactose or microcrystalline cellulose, magnesium stearate and/or calcium and, optionally, are presented in the following ratio of components,% by weight of active substance - tramadol hydrochloride:

Calcium phosphate dihydrate - 27,9 - 34,1

Lactose or microcrystalline cellulose - 160,3 - 195,9

Magnesium stearate and/or calcium - 0,8 - 1,1

Aerosil - 0 - 5,5

The proposed ratio of the active substance and the target additives found experimentally and is optimal, satisfying all the requirements of the current Gosfarmakapei XI publications and regulatory documents capsules tramadol. In particular, uniformity of dosage of 4.5% (at a rate of 10%); the dissolution,% - 85-100 (with the norm of "not less than 75")="ptx2">

Example 1. In the mixer and mixed until uniform distribution of the ingredients 50.0 g of tramadol hydrochloride, 17.0 g of calcium phosphate dihydrate, 97,0 g of lactose, and 0.5 g of magnesium stearate. Encapsulation resulting mixture to produce a machine for encapsulation in gelatin capsules. Receive, on average, 1020 - 1030 capsules with each capsule 0.05 g of 5% tramadol hydrochloride.

Example 2. Getting capsules tramadol hydrochloride carried out as in example 1, on the basis of 50.0 g of tramadol hydrochloride, 14.0 g of calcium phosphate dihydrate, an 80.2 g of microcrystalline cellulose, 2.25 g of Aerosil and 0.42 g of calcium stearate. Receive, on average, 900-920 capsules with each capsule 0.05 g of 4.5% of tramadol hydrochloride.

Pharmaceutical composition having an analgesic effect, containing as active substance an effective amount of tramadol hydrochloride and target additives, characterized in that it is enclosed in a hard gelatin capsule and the target additives contains calcium phosphate dihydrate, lactose or microcrystalline cellulose, magnesium stearate and/or calcium and, optionally, are presented in the following ratio of components, % by weight of existing homestart magnesium and/or calcium - 0,8 - 1,1

Aerosil - 0 - 5.5 tons

 

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SUBSTANCE: one should perform puncturing of epidural space at Th12-L1 level. Through the lumen of puncture needle one should introduce catheter to move it cranially at the depth of 3 cm. After that one should inject 10 ml 05%-marcaine solution to perform repeated injections per 5.0 ml every 4 h during 1-8 d. The effect is achieved due to unloading minor cycle of circulation.

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