IPS1 - [Sterile Dosage Forms] - Ophthalmic Products

Proverbs 16:3

● Solutions

● Suspensions

● Gels

● Ointments

● Drug-impregnated inserts

● Contact lenses and contact lens care products

Ophthalmic Dosage Forms

● Sterility

● Preservation

● Isotonicity

● Buffering

● Viscosity and Thickening

● Clarity

● Finely divided particles for Suspensions

Special considerations for ophthalmic solutions and suspensions include:

TRUE

[SPECIAL CONSIDERATIONS]

TRUE OR FALSE:

Most ophthalmic products CANNOT be sterilized by HEAT since the active principles or polymers used to increase viscosity are not stable to heat.

Autoclaving

[SPECIAL CONSIDERATIONS]

This sterilization method is NOT suitable for PLASTIC containers or heat-sensitive drugs.

Bacterial filtration

[SPECIAL CONSIDERATIONS]

This sterilization method is effective for SOLUTIONS but not suitable for suspensions.

● Benzalkonium chloride

● Benzethonium chloride

● Chlorobutanol

● Phenylmercuric acetate

● Phenylmercuric nitrite

[SPECIAL CONSIDERATIONS]

Preservatives to prevent microbial growth:

TRUE

[SPECIAL CONSIDERATIONS]

TRUE OR FALSE:

Lacrimal fluid is isotonic with blood (~0.9% NaCl).

0.6% - 2%

[SPECIAL CONSIDERATIONS]

Sodium chloride equivalent for isotonic ophthalmic solutions

TRUE

[SPECIAL CONSIDERATIONS]

TRUE OR FALSE:

Some ophthalmic solutions are HYPERTONIC in order to enhance absorption and provide a concentration of the active ingredients strong enough to exert an effective action.

● For greater comfort to the eye

● To render the formulation more stable

● To enhance the aqueous solubility of the drug

● To enhance the drug's bioavailability

● To maximize preservative efficacy

[SPECIAL CONSIDERATIONS]

Purposes of buffering

● Hydroxypropyl methylcellulose

● Polyvinyl alcohol

[SPECIAL CONSIDERATIONS]

Thickeners used in ophthalmic preparations

15-25 centipoise (cp)

[SPECIAL CONSIDERATIONS]

Ophthalmic solutions' optimal viscosity is ___ cp.

Viscosity

[SPECIAL CONSIDERATIONS]

____of the product aids in maintaining the drug in contact with the tissues to enhance therapeutic effectiveness.

TRUE

[SPECIAL CONSIDERATIONS]

TRUE OR FALSE:

Ophthalmic solutions must be sparkling CLEAR and free of all particulate matter.

TRUE

[SPECIAL CONSIDERATIONS]

TRUE OR FALSE:

Drug particles in ophthalmic suspension must be FINELY divided to minimize eye irritation and/or scratching of the cornea.

Small glass bottles with glass or plastic droppers

Most are packaged in soft plastic containers with a fixed built-in dropper.

[PACKAGING]

Packaging of ophthalmic solutions