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Injectable compositions and process of preparation thereof

A composition and mixture technology, applied in the direction of drug combination, pharmaceutical formulation, drug delivery, etc.

Inactive Publication Date: 2008-07-09
PANACEA BIOTEC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Therefore, there is a need for the development of effective non-toxic parenteral compositions comprising COX-II inhibitors or NSAIDs (in which the latter are substantially soluble) and those combinations which do not have the above-mentioned problems and remain stable throughout the shelf-life of the product There are still unmet needs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment -1

[0077] Example-1: Nimesulide Injection (100mg / 3ml)

[0078] S.No. Ingredient Quantity / 100ml

[0079] 1. Polyethylene glycol (PEG-400) 30.00ml

[0080] 2. Propylene glycol 20.00ml

[0081] 3. Glycine buffer pH 11.3 36.00ml

[0082] 4. Nimesulide 3.34gm

[0083] 5. Sodium hydroxide (NaOH) solution 4.0% w / v 11.20ml

[0084] method:

[0085] i) Take the specified amount (30.00ml) of PEG-400 in the container.

[0086] ii) Propylene glycol (20.00ml) was added to step (i) with continuous stirring using a mechanical stirrer.

[0087] iii) Add approximately 30.0ml of glycine buffer pH 11.3 to step (ii) with continuous stirring to form a homogeneous mixture.

[0088] iv) Add a weighed amount of Nimesulide (3.34 gm) passed through a #60 sieve to step (iii) with continuous stirring.

[0089] v) The specified amount (11.20 ml) of NaOH 4.0% solution was added to step (iv) with continuous stirring to form a homogeneous solution.

[0090] vi) Mix the solution for approximately 30 min...

Embodiment -2

[0095] Example-2: Diclofenac Injection (75mg / 3ml)

[0096] S.No. Ingredient Quantity / 100ml

[0097] 1. Polyethylene glycol (PEG-300) 30.00ml

[0098] 2. Propylene glycol 20.00ml

[0099] 3. Glycine buffer pH 12.0 30.00ml

[0100] 4. Diclofenac 2.50gm

[0101] 5. Sodium hydroxide (NaOH) solution 4.0% w / v 10.00ml

[0102] method:

[0103] i) Take the specified amount (30.00ml) of PEG-300 in the container.

[0104] ii) Propylene glycol (20.00ml) was added to step (i) with continuous stirring.

[0105] iii) Add approximately 25.0 ml of glycine buffer pH 12.0 to step (ii) with continuous stirring to form a homogeneous mixture.

[0106] iv) Add weighed amount of Diclofenac through #60 sieve to step (iii).

[0107] v) The specified amount (10.00 ml) of NaOH 4.0% solution was added to step (iv) with continuous stirring to form a homogeneous solution.

[0108] vi) Mix the solution for approximately 30 minutes with continuous stirring.

[0109] vii) Add remaining amount of gly...

Embodiment -3

[0113] Example-3: Indomethacin Injection (25mg / 3ml)

[0114] S.No. Ingredient Quantity / 100ml

[0115] 1. Polyethylene glycol (PEG-400) 30.00ml

[0116] 2. Propylene glycol 20.00ml

[0117] 3. Lysine Buffer pH 10 42.00ml

[0118] 4. Indomethacin 0.84gm

[0119] 5. Sodium hydroxide (NaOH) solution 4.0% w / v 11.20ml

[0120] method:

[0121] i) Take the specified amount (30.00ml) of PEG-400 in the container.

[0122] ii) Propylene glycol (20.00ml) was added to step (i) with continuous stirring.

[0123] iii) Add about 36.0ml of lysine buffer to step (ii), stirring continuously.

[0124] iv) Add weighed amount of indomethacin passed through #60 mesh to step (iii).

[0125] v) The specified amount (11.20 ml) of NaOH 4.0% solution was added to step (iv) with continuous stirring to form a homogeneous solution.

[0126] vi) Mix the solution for approximately 30 minutes with continuous stirring.

[0127] vii) Add remaining amount of lysine buffer to step (vi).

[0128] viii) ...

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PUM

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Abstract

Novel and highly stable injectable pharmaceutical compositions comprising at least one cyclooxygenase-II enzyme (COX-II) inhibitor or non-steroidal anti-inflammatory drug (NSAID) or COX / LOX inhibitor, or its tautomeric forms, analogues, isomers, polymorphs, solvates, prodrugs or salts thereof as active ingredient suitable for parenteral administration preferably by intramuscular (IM) or intravenous (IV) route; process of preparing such compositions and therapeutic methods of using such compositions are provided. The analgesic and anti-inflammatory injectable compositions of the present invention are very useful in mammals particularly in humans for the treatment of acute painful conditions like one or more of post-operative trauma, pain associated with cancer, sports injuries, migraine headache, neurological pain and pain associated with sciatica and spondylitis, and the like, and / or chronic painful conditions, and / or a variety of painful and inflammatory conditions like postoperative pain, primary dysmenorrhea and painful osteoarthritis, and / or other associated disorders such as inflammation, fever, allergy, or the like.

Description

field of invention [0001] The present invention relates to novel and highly stable injectable pharmaceutical compositions comprising as active ingredient at least one cyclooxygenase-II enzyme (COX-II) inhibitor or non-steroidal anti-inflammatory drug (NSAID) or COX / LOX inhibitors, or tautomeric forms, analogs, isomers, polymorphs, solvates, prodrugs or salts thereof, the composition is suitable for parenteral administration, preferably by intramuscular (IM) or intravenous (IV) routes; methods of making the compositions and methods of treatment using the compositions. [0002] The analgesic and anti-inflammatory injectable compositions of the present invention are very useful in mammals, especially humans, for the treatment of acute pain conditions such as post-surgical trauma, pain associated with cancer, sports injuries, migraine, nerve pain and One or more of pain associated with sciatica and spondylitis, etc., and / or chronic pain conditions, and / or other associated disord...

Claims

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Application Information

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IPC IPC(8): A61K9/08
CPCA61K9/0019A61K47/183A61K31/405A61K47/10A61P25/04A61P29/00A61K9/00A61K9/08
Inventor R·简K·C·津达尔S·辛格S·博尔哈内
Owner PANACEA BIOTEC
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