Vous êtes sur la page 1sur 1

F O R M U L A T I O N S

Idoxuridine 0.5% Ophthalmic Ointment

Rx
Idoxuridine
Mineral oil
White petrolatum

qs

500 mg
5g
100 g

METHOD OF PREPARATION
Note: This product should be prepared in a laminar airflow hood by a validated,
aseptic compounding pharmacist using aseptic technique.
1. Determine the total quantity to be prepared and accurately weigh the
appropriate amounts of each ingredient.
2. Dry heat sterilize the mineral oil and the white petrolatum.
3. Thoroughly levigate the previously sterilized, finely powdered idoxuridine in the sterile mineral oil.
4. Incorporate the sterile white petrolatum until uniformly mixed.
5. Package and label.

PACKAGING
Package in sterile, light-resistant ophthalmic tubes or 1-cc tuberculin
syringes.

LABELING
For the eye. Do not touch tip to eye or eyelid. Discard after ____
(expiry date).

STABILITY
An appropriate beyond-use date for this unpreserved product is not later
than the intended duration of therapy or 30 days, whichever is earlier.1

DISCUSSION
Idoxuridine is used in the treatment of herpes simplex and keratoconjunctivitis and, to a limited extent, ocular vaccinia infections and cutaneous
herpes simplex. Idoxuridine is available as a white, crystalline powder that
is practically odorless but will turn black when heated to 171C. It is
slightly soluble in water or alcohol. The pH of a 0.1% aqueous solution
is about 6. The ointment dosage form does not require as frequent administration as the ophthalmic solution. 2,3
Mineral oil (heavy mineral oil, liquid paraffin, liquid petrolatum, paraffin oil, white mineral oil) is a transparent, colorless, viscous liquid that is
practically tasteless and odorless when cold; when warm, it has a faint odor.
It is used as an emollient, solvent, lubricant, therapeutic agent and oleaginous vehicle. It has a specific gravity of 0.845 to 0.905 and a boiling point
of greater than 360C. It is practically insoluble in 95% ethanol, glycerin
and water. It is soluble in acetone, chloroform and petroleum ether. It is
miscible with volatile and fixed oils, with the exception of castor oil. To
promote miscibility/solubilization, a small amount of a suitable surfactant
can be added. When exposed to heat and light, it undergoes oxidation; with
the formation of peroxides and, ultimately, involvement of an autocatalytic
process. Stabilizers, such as butylated hydroxyanisole, butylated hydroxytoluene and -tocopherol can be used as antioxidants to retard the oxidative
process. Mineral oil can be sterilized by dry heat and should be stored in
an airtight container, protected from light in a cool place. It is incompatible with strong oxidizing agents.4
White petrolatum (white petroleum jelly, white soft paraffin) is a white-

colored, translucent, soft unctuous mass that is inert, odorless and tasteless. It is a mixture of semisolid saturated hydrocarbons obtained from
petroleum. It is used primarily in topical pharmaceutical formulations in
emollient creams (10% to 30% concentration), topical emulsions (4% to
25% concentration) and topical ointments (up to 100% concentration). It
has a specific gravity of about 0.815 to 0.880 and melts in a range between
38 to 60C. It is practically insoluble in ethanol, glycerin and water, but
is soluble in chloroform and most fixed and volatile oils. It is stable but,
upon exposure to light, it may discolor due to oxidation of some impurities in the product. This oxidation can be minimized by the addition of a
suitable antioxidant, such as butylated hydroxyanisole, butylated hydroxytoluene or -tocopherol. Heating above its melting range (about 70C) for
extended times should be avoided, but it can be sterilized by dry heat.5

References
1. United States Pharmacopeia XXIII/National Formulary 18. Rockville, MD,
U.S. Pharmacopeial Convention, Inc., 1995, pp 3131-3135.
2. McEvoy GK (ed). AHFS Drug Information-1997. Bethesda, MD, American Society of Health-System Pharmacists, 1997, pp 2114-2115.
3. Nichols WK. Anti-infectives. In Gennaro AR (ed). Remington: The Science and Practice of Pharmacy, Easton, PA, Mack Publishing Co., 1995,
p 1334.
4. Reier GET, Wadke DA. Mineral oil. In Wade A, Weller PJ (eds). Handbook of Pharmaceutical Excipients, ed 2. Washington, DC, American Pharmaceutical Association, 1994, pp 314-315.
5. Weller PJ. Petrolatum. In Wade A, Weller PJ (eds). Handbook of Pharmaceutical Excipients, ed 2. Washington, DC, American Pharmaceutical Association, 1994, pp 331-333.

International Journal of Pharmaceutical Compounding


231
Vol. 2 No. 3 May/June 1998

Vous aimerez peut-être aussi