Page 37 - Pharmaceutics-II (02-06-01 203)
P. 37
These quality control tests are performed to provide assurances of batch-to-batch quality,
reproducibility, reliability, and performance.
Special Considerations
1. For creams: Special tests are needed regarding globule size, and phase separation since these
are important criteria in the stability of the emulsified dosage form.
2. Particle size of the solid is of crucial importance in ophthalmics, and in pastes (the large
amount of solid with large PS can cause skin abrasion and irritation).
➢ For ophthalmics, PS should not exceed 90 µm to avoid eye irritation
➢ PS affects the penetration of drug through the skin:
PS < 3 nm, penetrate both stratum corneum and hair follicle,
PS > 10 nm don’t cross the epidermis
PS 3-10 nm concentrated in hair follicle
3. Sterility test for ophthalmic preparations
Semi solids in cosmetic preparations
What are cosmetic preparations?
Cosmetic, are preparations (excluding soap) that are applied to the human body for beautifying,
preserving, or altering the appearance or for cleansing, colouring, conditioning, or protecting the
skin, hair, nails, lips, eyes, or teeth.
1. Emulsions:
• Emulsions are the most widely used dosage forms in the cosmetic industry due to their
advantages over other dosage forms.
• They have a unique texture and provide a nice skin feel
• They are used as vehicles to deliver both hydrophilic and hydrophobic ingredients
36