FORM 2
THE PATENTS ACT, 1970
(39 OF 1970)
&
PATENTS RULES, 2006
PROVISIONAL SPECIFICATION (SECTION 10; RULE 13)
"PARENTERAL COMPOSITIONS OF SATRANIDAZOLE"
ALKEM LABORATORIES LIMITED, A COMPANY INCORPORATED UNDER THE COMPANIES ACT, 1956, HAVING ITS CORPORATE OFFICE AT ALKEM HOUSE, DEVASHISH, ADJACENT TO MATULYA CENTRE, S.B.MARG, LOWER PAREL, MUMBAI - 400013, MAHARASHTRA, INDIA.
THE FOLLOWING SPECIFICATION DESCRIBES THE NATURE OF THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED:
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ABSTRACT:
The present invention relates to a process for preparing Satranidazole solution for parenteral administration, wherein a solution is formed of using cosolvency technique in a mixture of water, water miscible organic solvents and adjuvants for adjusting the pH, tonicity modifiers and crystal inhibitors and to Satranidazole Parenteral solutions which can be obtained by said process.
BACKGROUND OF THE INVENTION:
Oral dosage forms of Satranidazole are available in India but there is no literature related to parenteral dosage forms of Satranidazole.
SUMMARY OF THE INVENTION:
The objective of the present invention is to provide a parenteral dosage form comprising Satranidazole
DETAILED DESCRIPTION OF INVENTION:
The present invention provides a parenteral pharmaceutical composition having Satranidazole as active pharmaceutical ingredient which can be administered by Intramuscular, Intravenous, subcutaneous or any other parenteral route.
The invention comprises water for injection, pharmaceutically acceptable solubilizing agents, co-solvents, crystal inhibitors and adjuvants for adjusting the pH and isotonicity.
This invention comprises pharmaceutically acceptable solubilizing agents such as n methyl-2-pyrrolidone-, dimethyl sulfoxide, cremopher, cyclodextrin, betacyclodextrin, hydroxypropyl-P-cyclodextrin, sulfobutylether- p cyclodextrin etc.
This invention comprises pharmaceutically acceptable co-solvents such as polyethylene glycol 400, propylene glycol etc.
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This invention comprises pharmaceutically acceptable tonicity modifiers such as dextrose, sodium
chloride etc.
This invention comprises pharmaceutically acceptable crystal inhibitors such as
polyvinylpyrrolidone (PVP k-30) etc.
This invention comprises pharmaceutically acceptable ph adjuvants such as sodium hydroxide,
hydrochloric acid etc.
The formula for the preparation of Satranidazole infusion: Example 1:

S.NO. NAME OF MATERIAL %w/v
1. Satranidazole 0.5 to 30%
2. Polyethylene glycol 400 6% to 40%
3. Dimethyl Sulfoxide 0.2 to 10%
4. Dextrose 5%
5. Povidone (PVP K30) 0.2% to 5%
6. Water for injection Quantity sufficient to 100%
Manufacturing process:
Step 1: Dimethyl Sulfoxide was taken and dissolved in it Satranidazole and Polyvinyl Pyrrolidone (PVP K-30) under stirring.
Step 2: Then added to Step 1, polyethylene glycol 400 under constant stirring.
Step 3: Adjusted the pH with 0.IN HC1 or with 0. IN Sodium Hydroxide.
Step 4: Then added dextrose solution and made up the volume with water for injection.
Step 5: Filtered the solution through 0.45 micron filter paper.
Step 6: Filled and Sterilized by autoclaving
Example 2:
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S.NO. NAME OF MATERIAL Qty
1. Satranidazole 300mg
2. Dimethyl acetamide 3.5ml
3. Benzyl alcohol 0.2 ml
4. Polyethylene glycol 400 up to 5ml
Manufacturing process:
Step 1 Dissolve satranidazole in Dimethyl acetamide.
Step 2: Then add benzyl alcohol and make up the volume to 5 ml with Polyethylene glycol -400(PEG-400).
Dated this 18th day of August 2006.
Sanjay Kher
Applicants’ Patent Agent.
To:
The Controller of Patents, Patent Office, Mumbai 400 037
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