Maxima Pharmaceuticals - Information for the Pharmacist

INFORMATION FOR THE PHARMACIST

WHAT IS THE MOST COMMON TRANSDERMAL DICLOFENAC PRESCRIPTION?

By far, the most common prescription is for a 100 g jar of 5% diclofenac in DiffusiMAX^® . It may be written in generic form as 5% diclofenac in PLO gel. Since DiffusiMAX is PLO gel, it can be used for any PLO gel prescription.

5% Diclofenac Using the DIFFUSIMAX KIT

To make 100 grams of 5% diclofenac using the DiffusiMAX Kit :

Clean equipment with alcohol.
Weigh out 5 grams diclofenac powder and place in a mixing vessel.
Make a paste by adding 5 mL of solvent [either ethyl alcohol (95%), isopropyl alcohol (70%) or propylene glycol]. Avoid using too much solvent, as this will reduce the consistency of the final product. The paste may be slightly granular.
If Compound A has been cooled, it may be solid. Warming to room temperature will allow it to liquefy for use. Compound B has the unusual property of solidifying at room temperature. To liquefy, refrigerate for at least 10 minutes prior to use.
Measure 24 mL DiffusiMAX Compound A and gradually add it to the diclofenac paste. Mix until smooth.
Measure 71 mL DiffusiMAX Compound B .
The final product can be made in an ointment jar. Add the DiffusiMAX Compound B to the DiffusiMAX Compound A/diclofenac mixture. Mix the two compounds until a thick cream is produced.
For cleanup, wipe equipment, rinse with cold water, and then wash with detergent.

Note: DiffusiMAX™ Kits are prepackaged in the proper lipophilic:hydrophilic ratio. If you need to make a different size prescription, use a ratio of one part Compound A (lipophilic) to three parts Compound B (hydrophilic).

HOW SHOULD I STORE DIFFUSIMAX COMPOUND A AND COMPOUND B BEFORE USE?

Both Compound A and Compound B are stable at room temperature. The kit can be kept intact at room temperature until use. Compound B is solid at room temperature, so it should be refrigerated for 10 minutes prior to use to allow it to liquefy. It may be more convenient to separate the components of the kit, storing Compound A at room temperature and keeping Compound B in the refrigerator.

HOW DO I STORE THE FINAL PRODUCT?

Diclofenac in PLO gel should be stored at room temperature. Cooling may liquefy the final product. If this occurs, further mixing can restore consistency. Shelf life of the diclofenac/DiffusiMAX product is six (6) months.

5% Diclofenac Using DIFFUSIMAX PRE-MIXED CREAM

To make 100 grams of 5% diclofenac in DiffusiMAX premixed cream:

Clean equipment with alcohol.
Weigh out 5 grams of diclofenac powder and place in a mixing vessel.
Make a paste by adding 5 mL of solvent [either ethyl alcohol (95%), isopropyl alcohol (70%) or propylene glycol]. Avoid using too much solvent, as this will reduce the consistency of the final product. The paste may be slightly granular.
Measure out the required amount of DiffusiMAX premixed cream (100 grams minus the weight of the drug). If the cream had previously been cooled, it may be partially liquid. Mixing will restore its proper consistency.
Mix the diclofenac paste into the DiffusiMAX cream. The final product can be made in the ointment jar.
For clean-up, wipe equipment, rinse with cold water, and then wash with detergent.

HOW SHOULD I STORE DIFFUSIMAX PRE-MIXED CREAM BEFORE USE?

DiffusiMAX pre-mixed cream is stable at room temperature and should be stored at room temperature. Cooling may liquefy the pre-mixed cream. If this occurs, consistency can be restored by mixing with a spatula.

HOW DO I STORE THE FINAL PRODUCT?

Diclofenac in PLO gel should be stored at room temperature. If it is cooled, it may liquefy. If this occurs, consistency can be restored by mixing. Shelf life of the Diclofenac/DiffusiMAX product is six (6) months.

MAXIMA PHARMACEUTICALS, EDMONTON, ALBERTA, CANADA
PHONE: 1-888-MAXIMA8 (toll free)
Comments or questions? Write to us at: info@maximapharmaceuticals.com