6. Explain the USP Tests for Ointments.

a. Microbial Content

 Preparations prone to microbial growth must contain antimicrobial preservatives.

 Preparations that contain water tend to support microbial growth to a greater extent than
water-free preparations.
 Microbial limits are stated for certain articles in the USP.
 Antimicrobial preservatives: methylparaben, propylparaben, phenols, benzoic acid,
sorbic acid, and quaternary ammonium salts.
 The USP states certain products should be routinely tested for microorganisms because
of the way they are used.
b. Minimum Fill

 The USP's minimum fill test is determination of the net weight or volume of the contents
of filled containers to ensure proper contents compared with the labeled amount.
c. Packaging, storage and labeling

 Ointments and other semisolid preparations are packaged either in large-mouth ointment
jars or in metal or plastic tubes.
 Semisolid preparations must be stored in well-closed containers to protect against
contamination and in a cool place to protect against product separation in heat.
 Light-sensitive preparations are packaged in opaque or light-resistant containers.
 The USP directs the labeling for certain ointments and creams including proper storage
conditions, dosing and administration.
7.What are the packaging materials for ointment?

 Ointment jars are made of clear or opaque glass or plastic. Opaque jars, used for light
sensitive products, are porcelain white, dark green, or amber.
 Tubes used to package topical pharmaceutical products. They are light in weight,
relatively inexpensive, convenient for use, and compatible with most formulative
components, and they provide greater protection against external contamination and
environmental conditions than jars.
 Ointment tubes are made of aluminum or plastic.
 Ophthalmic ointments typically are packaged in small aluminum or collapsible plastic
tubes holding 3.5 g (about 0.125 oz) of ointment.
 Either syringes for injection or syringes for oral use have been successfully used for
ointments.
8. What are the different layers of the skin and where will absorption of the drug into the
circulation takes place?

 The skin is divided histologically into the stratum corneum (the outer layer), the living
epidermis, and the dermis, collectively a laminate of barriers protecting against
permeation by external agents and loss of water from the body.
 The film covering the stratum corneum varies in composition, thickness, and continuity
as a result it offers little resistance to drug penetration.
  Hair follicles and gland ducts can provide entry for drug molecules, but because their
relative surface area is so minute compared to the total epidermis, they are minor factors
in drug absorption.
 The stratum corneum, being keratinized tissue, behaves as a semipermeable
membrane, and drug molecules can penetrate by passive diffusion.
9.What are the major and alternative routes for drugs to enter the eye?

 The major route by which drugs enter the eye is simple diffusion via the cornea.
 For drugs that are poorly absorbed by the cornea, the conjunctiva and sclera provide an
alternate route .