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Permithrin - Preformulation Study

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Orbit Pharmaceuticals Ltd
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37 views2 pages

Permithrin - Preformulation Study

Uploaded by

Orbit Pharmaceuticals Ltd
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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PRODUCT DEVELOPMENT DEPARTMENT

PREFORMULATION STUDY
A Jahurul Islam Company

Product Name Permethrin Cream


01

02 Generic Name Permethrin BP

03 Dosage Form Cream

Strength Each gram cream contains Permethrin BP 50 mg


04
Category It is indicated for the treatment and prevention in exposed individuals of head lice and
05 treatment of scabies
Available Market Innovator: Permethrin 5% w/w cream.
06 Sample Local: Scabex ( Square), Lorix ( Opsonin)
Packaging Mode of Innovator: Aluminium tube with polypropylene cap
07 the Market Sample Local: Laminated Tube
Details description of Colorless or slightly brownish viscous liquid, semi-solid or crystalline solid.
08
API
8.1 Chemical C21H20Cl2 O3
Formula
8.2 Chemical
Structure

8.3 Molecular 391.3 g/mol


Weight
8.4 CAS Number 52645-53-1
8.5 Hygroscopicity Non Hygroscopic
8.6 Light Sensitivity Light Sensitive
8.7 Solubility Practically insoluble in water, Very soluble in heptane, Feely soluble in anhydrous
ethanol, sparingly soluble in ethylene glycol.
9 Metabolism Metabolism of permethrin occurs mainly in the liver, where the molecule undergoes
oxidation by the cytochrome P450 system, as well as hydrolysis, into metabolites.
10 Half Life Permethrin is quite stable, having a half life of 51–71 days in an aqueous environment
exposed to light. It is also highly persistent in soil.
11 Excretion Elimination of these metabolites occurs via urinary excretion
12 Drug Interaction No interactions are known.
The treatment of eczematous-like reactions with corticosteroids should be withheld prior
to treatment with Permethrin 5% w/w Cream, as there is a risk of exacerbating the
scabies infestation by reducing the immune response to the mite. The likelihood of
interactions between the two treatments leading to potentiated adverse reactions or
reduced efficacy is, however small.
14 Certificate of Present
Analysis of API
15 Method of Analysis Present
(For INN Material)
16 Chemical Active Information not available
Incompatibility Incompatibility:

Page 1 of 2
PRODUCT DEVELOPMENT DEPARTMENT
PREFORMULATION STUDY
A Jahurul Islam Company

Active- Information not available


Excipients
Incompatibility:

17 Formulation in Permithrin ,Cetylstearyl alcohol, White soft paraffin, Macrogol cetostearyl


International Market ether ,Isopropylmyristate, Benzyl alcohol, Purified water
18 Proposed
Formulation Lab batch BMR

19 Others N/A

Prepared By:……………… Checked By:…………….. Reviewed By:………………..

Page 2 of 2

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