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Method of reducing somnolence in patients treated with tizanidine

a technology of tizanidine and somnolence, which is applied in the field of somnolence, can solve the problems of increasing the likelihood of somnolence, and achieve the effect of reducing somnolen

Inactive Publication Date: 2013-09-12
KING GEORGE HLDG LUXEMBOURG IIA S A R L
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes a new way to make a medication called tizanidine that reduces the feeling of drowsiness it can cause when taken with food. This is done by making the medication into a powdered form that can be taken with or without food. The new formulation of tizanidine also has a slower absorption rate when taken with food, which means it takes longer for the medication to start working in the body. The new formulation is also safer and tolerable, and can be made into a pill or liquid form for patients who need it.

Problems solved by technology

This result is wholly unexpected in comparison to earlier clinical studies of the tablet formulation which, when taken with food, significantly increases likelihood of somnolence.

Method used

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  • Method of reducing somnolence in patients treated with tizanidine

Examples

Experimental program
Comparison scheme
Effect test

example 2

(a) Immediate Release Multiparticulates

[0061]A Tizanidine HCl Application Solution is prepared as described in the Description of Individual Process Steps above according to the formulation in Table 3. The Tizanidine HCl Application Solution is then coated onto non-pareil seeds to a level of approximately 7.0% solids weight gain using for example a Glatt GPCG 5 (Glatt, Protech Ltd., Leicester, UK) fluid bed coating apparatus to form Immediate Release Multiparticulates as described in the Description of Individual Process Steps above.

TABLE 3Tizanidine HCl Application SolutionIngredientAmount (% w / w)Tizanidine HCl3.59Hydroxypropyl Methylcellulose 6 cps2.50Silicon Dioxide1.65Purified Water92.26

[0062]Immediate Release Capsules

[0063]The Immediate Release Multiparticulates prepared according to Example 2(a) above are encapsulated into hard gelatin capsules to the required dosage strength as described in the Description of Individual Process Steps above.

TABLE 4Immediate Release Capsules2 m...

example 3

(a) Immediate Release Multiparticulates

[0065]A Tizanidine HCl Application Solution is prepared as described in the Description of Individual Process Steps above according to the formulation in Table 5. The Tizanidine HCl Application Solution is then coated onto non-pareil seeds to a level of approximately 9.5% solids weight gain using for example a Glatt GPCG 3 (Glatt, Protech Ltd., Leicester, UK) fluid bed coating apparatus to form Immediate Release Multiparticulates as described in the Description of Individual Process Steps above.

TABLE 5Tizanidine HCl Application SolutionIngredientAmount (% w / w)Tizanidine HCl3.59Polyvinylpyrrolidone4.96Silicon Dioxide1.65Purified Water89.79

[0066](b) Immediate Release Capsules

[0067]The Immediate Release Multiparticulates prepared according to Example 3(a) above are encapsulated into hard gelatin capsules to the required dosage strength as described in the Description of Individual Process Steps above.

TABLE 6Immediate Release Capsules2 mg Capsule4 ...

example 4

(a) Immediate Release Multiparticulates

[0069]A Tizanidine HCl Application Solution is prepared as described in the Description of Individual Process Steps above according to the formulation in Table 7. The Tizanidine HCl Application Solution is then coated onto non-pareil seeds to a level of approximately 8.6% solids weight gain using for example a Glatt GPCG 30 (Glatt, Protech Ltd., Leicester, UK) fluid bed coating apparatus to form Immediate Release Multiparticulates as described in the Description of Individual Process Steps above.

TABLE 7Tizanidine HCl Application SolutionIngredientAmount (% w / w)Tizanidine HCl2.54Hydroxypropyl Methylcellulose 3 cps3.95Talc1.50Purified Water91.56

[0070](b) Immediate Release Capsules

[0071]The Immediate Release Multiparticulates prepared according to Example 4(a) above are encapsulated into hard gelatin capsules to the required dosage strength as described in the Description of Individual Process Steps above.

TABLE 8Immediate Release Capsules4 mg Caps...

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PUM

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Abstract

An article and method for reducing somnolence in a patient receiving tizanidine therapy. Tizanidine may be administered in the form of an immediate release multiparticulate composition at or around the time food is consumed. The composition may be packaged in a container for distribution.

Description

FIELD OF THE INVENTION[0001]This invention relates to a method and composition for reducing a side effect, namely somnolence, in patients receiving tizanidine drug therapy.BACKGROUND OF THE INVENTION[0002]Tizanidine is pharmacologically characterized as a central-acting alpha2 (α2) adrenoceptor agonist which has myotonolytic activity useful in the treatment of spasticity in patients with cerebral or spinal injury, muscle spasm and pain. The imidazoline chemical structure of tizanidine is related to that of the anti-hypertensive drug clonidine and other alpha2-adrenergic agonists, however therapeutic indications are different between the two. Tizanidine has one-tenth to one-fiftieth ( 1 / 50) of the potency of clonidine in lowering blood pressure while clonidine is ineffective in treating spastic conditions. This spectrum of activities is true of the 2-amino-imidazoline alpha2 agonists in general where differences in the ring structures to which the amino group attaches cause marked di...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/50A61K9/48A61K9/00A61K31/433A61K9/16A61K31/41A61K31/415
CPCA61K9/1676A61K31/41A61K31/415A61K31/433A61K9/48A61K9/50A61K9/0002A61P25/00A61K9/4808
Inventor PELLEGRINI, CARA A.STARK, PAUL
Owner KING GEORGE HLDG LUXEMBOURG IIA S A R L
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