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Tips & Tricks from the Lab: Compounding with the Lipoderm® Family of Bases

3 MIN READ|
0 Comment |
3038 |
by PCCA|
July 12, 2023 |
General Pharmacy Compounding

by Melissa Merrell Rhoads, PharmD, PCCA Director of Formulations

We introduced our proprietary base, Lipoderm® (PCCA #30-3338), in the early 2000s. Now recognized as the first proprietary permeation-enhancing vehicle in the compounding industry, Lipoderm has since become an official USP Compounded Preparation Monograph for Ondansetron Compounded Topical Gel (20 mg/mL).

Our product innovations, however, did not end there. We subsequently introduced a family of Lipoderm permeation-enhancing bases that are scientifically proven to deliver active pharmaceutical ingredients (APIs) through the skin, as indicated by an ever-growing portfolio of peer-reviewed journal publications and FormulaPlus™ BUD-studied formulas.

The Lipoderm Family of Bases

Our Lipoderm family of products expands your options for topical compounded permeation-enhancing preparations to address the needs of your patients.

Lipoderm® (PCCA #30-3338) is great for general permeation-enhancing and deep-penetrating topical formulations.
Lipoderm ActiveMax® (PCCA #30-4482) is an excellent base for APIs with high-salt concentrations.
Lipoderm® HMW™ (PCCA #30-4612) works well for APIs with high molecular weights.
Anhydrous Lipoderm® (PCCA #30-4283) is perfect for APIs that are unstable in water.

Compounding Preparations

Lipoderm®	Lipoderm ActiveMax®	Lipoderm® HMW™	Anhydrous Lipoderm®
Low viscosity/separation due to API (salt load or incompatibility)
Use Krisgel 100™ 0.5-5% (0.1-0.5% is the most common concentration) Use Emulsifix®-205 0.5-10% (1-6% is the most common concentration) Use poloxamer 407 20% gel 10-25%	Use Krisgel 100 0.5-5% (0.1-0.5% is the most common concentration) Use Emulsifix-205 0.5-10% (1-6% is most common concentration) Use poloxamer 407 20% gel 10-25%	Use Krisgel 100 0.5-5% (0.1-0.5% is the most common concentration) Use Emulsifix-205 0.5-10% (1-6% is most common concentration) Use free base vs. salt form if possible	Avoid high-salt drugs and acids This base is incompatible with Krisgel 100 and Emulsifix-205 since they require water to congeal
Hardening of the Final Preparation & Particles on Ointment Mill (Flurbiprofen + Gabapentin as an Example)			Low Viscosity Due to Elevated Temperatures During Shipping
Use widest setting (3) on ointment mill. After milling, allow preparation to sit for up to 24 hours until hardening occurs (Formula #10533 takes 2 days to harden; other formulas average 24 hours). After hardening, re-mix with EMP for 3 minutes on medium setting (for a 100 Gm preparation).			Let preparation sit at room temperature for 24-48 hours; or refrigerate preparation for 12 hours.
Gumming Up/Stickiness (Often Seen with Diclofenac Combinations)			Hardening of Final Preparation Due to Low Temperature
Add propylene glycol 5% + ETOH 190 proof 5-10%. If the preparation decreases in viscosity, add Krisgel 100 0.4%. Wet diclofenac with 10% of poloxamer 407 gel (20%-30%). Mix well and set aside. Wet remaining powders with their usual wetting agent (diethylene glycol monoethyl ether, propylene glycol, ethyl alcohol, etc.). Combine in the EMP jar, q.s. with Lipoderm. Mix per formula instructions.	Add ETOH 190 proof 5-10%. If viscosity of preparation decreases, add Krisgel 100 0.4%. Wet diclofenac with 10% of poloxamer 407 gel (20% or 30%). Mix well and set aside. Wet any remaining powders with their usual wetting agent (diethylene glycol monoethyl ether, propylene glycol, ethyl alcohol, etc.). Combine in EMP jar, q.s. with Lipoderm. Mix per formula instructions.		Use shear force from ointment mill or EMP to decrease viscosity. Add Base G (almond oil NF (Sweet) 5-10%. Add Medium Chain Triglycerides NF 5-10%.
Low Viscosity Due to Shear Stress from Ointment Mill or EMP	NOTE: The guidelines provided here may not work in every case. The Lipoderm family of bases are emulsions and stability is dependent upon the combination and concentration of APIs and wetting agents. Each formula may respond differently. If creating a unique formula (not in the PCCA database), compound a small sample (~30 Gm) and observe for 12-24 hours to ensure compatibility. PCCA members with clinical services may contact our Clinical Services team for help compounding APIs and wetting agents using Lipoderm bases, as well as other compounding concerns.
Allow preparation to sit for 12-24 hours; add Krisgel 100 or Emulsifix-205 if needed.