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Preparation Ointment

This document provides instructions for preparing a topical analgesic formulation containing six active ingredients for the treatment of muscle and joint pain. The method involves heating polyethylene glycol to dissolve the mephenesin and capsicum oleoresin, then adding other ingredients like methyl salicylate, menthol, camphor and methyl nicotinate. The preparation is packaged and labeled for external use and can provide pain relief through different mechanisms of action over a 6 month shelf life if stored properly. Quality control testing may include assays of ingredients, pH and physical properties.

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Lyanlie Minamoto
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0% found this document useful (0 votes)
226 views1 page

Preparation Ointment

This document provides instructions for preparing a topical analgesic formulation containing six active ingredients for the treatment of muscle and joint pain. The method involves heating polyethylene glycol to dissolve the mephenesin and capsicum oleoresin, then adding other ingredients like methyl salicylate, menthol, camphor and methyl nicotinate. The preparation is packaged and labeled for external use and can provide pain relief through different mechanisms of action over a 6 month shelf life if stored properly. Quality control testing may include assays of ingredients, pH and physical properties.

Uploaded by

Lyanlie Minamoto
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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Method of Preparation: Calculate the quantity of each ingredient for the amount to be

prepared. Accurately weigh or measure each ingredient. Heat the polyethylene glycol (PEG)
4,000 to about 75°C. Add the mephenesin powder and stir until dissolved. Add the capsicum
oleoresin and stir until dissolved. Add the PEG 400, mix well, and cool to about 60°C. In a
separate vessel, mix the methyl salicylate, menthol, camphor, and methyl nicotinate and stir
until dissolved. Add this solution to the PEG mixture and mix well. Cool to room temperature
while mixing. Package and label.

Use: This preparation has been used in the treatment of muscle pain and arthritis.

Packaging: Package in tight, light-resistant containers.

Labeling: For external use only. Keep out of the reach of children. Discard after ____ [time
period].

Stability: A beyond-use date of up to 6 months may be used for this preparation.1

Quality Control: Quality-control assessment can include theoretical weight compared with
actual weight, pH, specific gravity, active drug assay, color, texture–surface, texture–spatula
spread, appearance, feel, rheologic properties, and physical observations.2

Discussion: Muscle and skeletal pain are often treated by combination therapy. This
preparation contains six active ingredients that have various mechanisms of relieving pain.

Mephenesin (Tolserol, C10H14O3, MW 182.22) occurs as white, odorless or almost odorless,


crystals or crystalline aggregates with a slightly bitter, numbing taste. It is soluble 1 in 100 in
water and 1 in 8 of alcohol. It has been used topically, usually with rubefacients.3

Methyl salicylate (C8H8O3, MW 152.15) occurs as a colorless, yellowish, or reddish liquid


with the characteristic odor and taste of wintergreen. It is slightly soluble in water and is
soluble in alcohol and glacial acetic acid. Methyl salicylate should be preserved in tight
containers; certain plastic containers (polystyrene) are unsuitable for liniments or ointments
containing methyl salicylate. Methyl salicylate is absorbed through the skin and is applied
topically in rheumatic conditions.2,3

Menthol (C10H20O, MW 156.27) occurs as colorless, hexagonal crystals, usually needlelike or


in fused masses, or as a crystalline powder. It has a pleasant, peppermintlike odor. Menthol is
slightly soluble in water and highly soluble in alcohol. It is freely soluble in fixed and volatile
oils.4

Camphor (C10H16O, MW 152.23) occurs as colorless or white crystals, granules, or


crystalline masses or as colorless to white translucent, tough masses. It has a penetrating,
characteristic odor and a pungent, aromatic taste. Camphor will slowly volatilize at room
temperature. It is slightly soluble in water, highly soluble in alcohol, and soluble in fixed and
volatile oils. Topically, camphor is used as a rubefacient and mild analgesic.1,3

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