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 Aqueous suspensions of solids intended to be

PREPARATION #22: CALAMINE LOTION, USP applied to the unbroken skin without friction. It
GUIDE QUESTION may also be emulsions or solutions.
1. Official title, category, synonyms, uses and official definition of CL e) Bentonite Magma
 Official title: Calamine Lotion, USP  A preparation of 5% bentonite in purified water.
 Category: Anti-puritic  Prepared in a blender with the bentonite added
 Synonyms: directly to the purified water while the machine is
 Uses: Astringent, anti-puritic, topical protectant running, or it may be prepared by sprinkling the
and soothing lotion to sunburn, treatment for ivy bentonite in portions upon hot purified water,
poisoning, skin protectant allowing each portion to be thoroughly wetted
2. Review of basic concepts without stirring before another portion is added.
a) Suspensions:  By the latter method, the mixture must be
 Preparations containing finely divided drug allowed to stand for 24 hrs before it may be
particles (the suspensoid) dispersed somewhat stirred to ensure complete hydration of the
uniformly in a vehicle in which the drug exhibits bentonite.
minimum solubility.  Used as a suspending agent, but its alkaline pH
 Insoluble dispersed phase (solid) in a dispersion must be considered during preparation of the
medium drug as its activity is reduced when pH is
b) Magmas & Milk: reduced to about 7.
 When the gel mass consists of floccules of small, 3. Give the use of each ingredient in the preparation.
distinct particles, making it a two-phase system,  Calamine = gives the anti-puritic action
as opposed to a single-phase system where o Calamine is made up of zinc oxide and
there is no apparent boundary between the ferric oxide (responsible for pink color)
dispersed phase and the dispersing medium. It is  Zinc oxide = gives the astringent action
a gel with a relatively large dispersed phase o antiseptic properties that help prevent
particle mass. infection from scratching
 When prepared they are thick and viscous,
 Glycerin
leading to their gel like consistency. They have
o Humectant: keeps water in the
no need for suspending agents due to this as
formulaion
well.
o Emollient: moisturizes the skin
c) Gel: o Wetting agent: helps disperse the
 Suspensions of small inorganic particles or large insoluble solids
organic molecules in which the movement of the  Bentonite magma = suspending agent
dispersing medium is restricted by the network of
particles or molecules formed by the dispersed
 Calcium hydroxide topical solution = Astringent
action, dispersion medium
phase, making it semisolid.
d) Lotion: 4. Reasons for important steps and special precautions in the preparation
 Why is trituration of powders ( zinc oxide and
calamine) done?

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o Intimately mix ingredients to form
uniform particle size
 During mixing, the remaining diluted magma
must be added gradually to prevent air from
being incorporated.
 CHTS is used as it dissolves both zinc oxide and
bentonite magma.
5. Quality control parameters (see QC sheet)
a) Theoretical Results
 Appearance : Pink, thick, creamy semi liquid
 pH: 9-10
 Pourability: Not easily poured
 Sedimentation Rate: Very slow to none
 Physical Stability: No sedimentation, caking and
microbial growth present
6. Packaging, labelling and storage requirements
 Packaging Requirement: Preserve in tight
containers.
 Label: Shake well before use.

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