PHLOJEL® Ultra Compounding Manual

FORMULA 1: Diclofenac sodium (DCF)

Strength: 2 – 20% w/w

Equipment: Slab & Spatula or Mortar & Pestle

Procedure:

S & S:

• Place the required amounts of PU and DCF on the slab in separate locations.

• Add a portion of PU to the DCF and triturate thoroughly to form a smooth nucleus.

• Add the remaining PU by geometric dilution, triturating until homogeneous.

M & P:

• Place the DCF in the mortar and triturate.

• Add a portion of PU and triturate thoroughly.

• Add the remaining PU by geometric dilution, triturating until homogeneous.

Comments:

• Do not add alcohol to maintain thickness.

• If a thicker product is desired, acidify with 0.5–1% citric acid or refrigerate.

• Mixing 10% DCF produces a thick cream without acidifying.

FORMULA 2: Ketoprofen (KTP)

Strength: 10 – 30% w/w

Equipment: Mortar & Pestle

Procedure:

• Add sufficient alcohol to the KTP in the mortar to form a paste. Levigate.

• Add all of the PU and triturate until homogeneous.

Comments:

• Some concentrations may yield a thinner product.

• Store in the refrigerator to firm up.

FORMULA 3: Ibuprofen (IBP)

Strength: 10 – 20% w/w

Equipment: Slab & Spatula

Procedure:

• Add approximately an equal amount of PU to the IBP on the slab. Levigate thoroughly.

• Add the remaining PU by geometric dilution, triturating and blending until homogeneous.

Comments:

• The final product is a smooth, non-gritty, firm white cream.

FORMULA 4: Naproxen (NPX)

Strength: 5 – 10% w/w

Equipment: Slab & Spatula

Procedure:

• Add alcohol to NPX on the slab sufficient to form a paste. Levigate.

• Add an equal amount (approx.) of PU to the paste.

• Triturate and blend to form a smooth nucleus.

• Add remaining PU by geometric dilution, triturating and blending until homogeneous.

Comments:

• Final product is a smooth, non-gritty, white cream.

FORMULA 5: Indomethacin (IDM)

Strength: 20% w/w

Equipment: Slab & Spatula

Procedure:

• Add enough alcohol* to IDM on the slab to form a paste. Levigate.

• Add an equal amount of PU to the paste. Triturate and blend.

• Add remaining PU by geometric dilution, triturating and blending thoroughly.

Comments:

• Final product is a non-gritty, soft, white cream.

FORMULA 6: Piroxicam (PXM)

Strength: 2.5% w/w

Equipment: Slab & Spatula

Procedure:

• Add enough alcohol* to PXM on the slab to form a paste. Levigate.

• Add an equal amount of PU to the paste. Triturate and blend.

• Add remaining PU by geometric dilution, triturating and blending thoroughly.

Comments:

• Final product is a non-gritty, yellow cream.

FORMULA 7: Ibuprofen 10% & Naproxen 10%

Equipment: Slab & Spatula

Procedure:

• Incorporate IBP in PU (see IBP monograph).

• Separately, add alcohol* to NPX to form a paste. Levigate.

• Gradually incorporate NPX paste into IBP/PU mixture by geometric dilution.

Comments:

• Final product is a smooth, non-gritty, thick, white cream.

FORMULA 8: Ibuprofen 10% & Piroxicam 2.5%

Equipment: Slab & Spatula

Procedure:

• Incorporate IBP in PU (see IBP monograph).

• Separately, add alcohol* to PXM to form a paste. Levigate.

• Gradually incorporate PXM paste into IBP/PU mixture by geometric dilution.

Comments:

• Final product is a smooth, non-gritty, pale yellow cream.

FORMULA 9: Metronidazole (MDZ)

Strength: 5% w/w

Equipment: Slab & Spatula

Procedure:

• Add alcohol* to MDZ on the slab to form a paste. Levigate.

• Add an equal amount of PU to the paste. Triturate and blend.

• Add remaining PU by geometric dilution, triturating and blending thoroughly.

Comments:

• Final product is a smooth, non-gritty, white cream.

FORMULA 10: Lidocaine HCl (LDN)

Strength: 4% w/w

Equipment: Slab & Spatula

Procedure:

• Add glycerol (~5%) to LDN on the slab to form a paste. Levigate.

• Spread the paste over the slab and layer the PU. Triturate and blend until homogeneous.

Comments:

• Final product is a uniform, non-gritty, off-white cream.

FORMULA 11: Progesterone (PG)

Strength: 3 – 6% w/w

Equipment: Slab & Spatula

Procedure:

• Add an equal amount of PU to PG on the slab. Levigate and blend to form a smooth nucleus.

• Add remaining PU by geometric dilution, triturating and blending thoroughly.

Comments:

• Final product is a smooth, non-gritty, white cream.

FORMULA 12: Tri-est (Estriol, Estradiol, Estrone)

Strength: 8 parts Estriol, 1 part Estradiol, 1 part EstroneDosage: 0.625 – 5 mg per dose; avg. 1.25 mg/dose

Procedure (50 g @ 1.25 mg/0.5 cc):

• Dissolve 125 mg estradiol, 125 mg estrone, 1000 mg estriol in 10 ml alcohol.

• Withdraw 1 ml and incorporate with PU using slab & spatula method to produce 50 g.

Procedure (10 g @ 1.25 mg/0.1 cc):

• Same as above, but mix with PU to make 10 g.

Comments:

• Store syringe in a cool, dry place—not the refrigerator.

FORMULA 13: Clindamycin (CM)

Strength: 2% w/w

Equipment: Slab & Spatula

Procedure:

• Add alcohol* to CM on the slab to form a paste. Levigate.

• Add an equal amount of PU to the paste. Triturate and blend.

• Add remaining PU by geometric dilution, triturating and blending thoroughly.

Comments:

• Final product is a smooth, non-gritty, white cream.

FORMULA 14: 5% Lidocaine base, 7.5% Ketoprofen, 5% Amitriptyline HCl (50 g)

Equipment: Slab & Spatula

Procedure:

• Levigate lidocaine with alcohol to make a slurry.

• Add amitriptyline HCl and levigate.

• Add ketoprofen and levigate, adding more alcohol if needed.

• Add 41.25 g PU to the slurry. Triturate and blend until homogeneous.

Comments:

• PU may appear chunky during mixing but smooths out with blending.

• Adding 5 g talc improves consistency.

• Refrigeration firms the product and gives a cooling effect when applied.

FORMULA 15: 5% Ketoprofen, 2% Cyclobenzaprine HCl (50 g)

Equipment: Slab & Spatula

Procedure:

• Place ketoprofen, cyclobenzaprine HCl, and PU on slab in separate quadrants.

• Mix 1 ml of 2M NaOH solution into PU.

• Spread PU and gradually blend in cyclobenzaprine HCl.

• Add alcohol to ketoprofen to make a paste. Levigate.

• Gradually incorporate levigated ketoprofen into PU/cyclobenzaprine mixture.

Comments:

• Final product is creamy and pale yellow.

• Without NaOH, the product is thinner but still usable.

FORMULA 16: Gabapentin (GPN)

Strength: 5%

Equipment: Slab & Spatula

Procedure:

• Levigate GPN with a portion of PU.

• Incorporate remaining PU by geometric dilution.

Comments:

• Produces a creamy, grit-free gel with consistent texture.

FORMULA 17: Testosterone free base (crystalline) (TFB)

Strength: 0.4%

Equipment: Slab & Spatula

Procedure:

• Levigate TFB with a small amount of alcohol or olive oil.

• Triturate with one-third of PU until uniform.

• Incorporate remaining PU by geometric dilution.

Comments:

• Creamy, grit-free gel with good spreadability.

FORMULA 18: Testosterone free base (crystalline) (TFB) – 20%

Procedure for 50 g:

• Triturate 10 g TFB with 13 ml (11 g) olive oil until smooth.

• Incorporate 40 g PU in portions. (Olive oil is not counted in final weight.)

Comments:

• Product is soft but firm and non-gritty.

FORMULA 19: 10% Ketoprofen, 10% Gabapentin, 2% Lidocaine HCl

Equipment: Mortar & Pestle

Procedure:

• Triturate ketoprofen and gabapentin with minimal alcohol.

• Triturate with equal amount of PU.

• Gradually add lidocaine HCl and triturate until uniform.

• Refrigerate before dispensing.

Comments:

• Runny during preparation; refrigerate to firm.

• Becomes liquid when applied to skin.

PHLOJEL® COMPOUNDING OVERVIEW

• Combine PHLOJEL® Hydrophilic and Organic in a 3:1 ratio.

• Triturate with drug(s) to form a smooth gel.

PHLOJEL®: Diclofenac sodium (DCF)Strength: 2 – 5% w/w

Procedure 1:

• Disperse DCF in PHLOJEL® Organic (no alcohol).

• Add PHLOJEL® Hydrophilic (~15°C) and triturate until smooth gel forms.

Procedure 2:

• Pre-mix PHLOJEL® components into gel.

• Incorporate DCF using mortar & pestle or slab & spatula.

  
  

Comments:

• Add 0.8% citric acid or 2 ml 2M HCl per 100 g to thicken.

PHLOJEL®: Ketoprofen (KTP)Strength: 10% w/w

Procedure:

• Levigate KTP with 4 ml alcohol per 50 g.

• Add PHLOJEL® Organic and disperse.

• Add PHLOJEL® Hydrophilic (15°C) and triturate until smooth.

Comments:

• Produces a smooth, grit-free gel.

PHLOJEL®: Naproxen (NPX)

Strength: 5 – 10% w/w

Equipment: Mortar & Pestle

Procedure:

• Add alcohol to NPX to form a paste. Levigate.

• Add PHLOJEL® Organic and disperse.

• Add chilled PHLOJEL® Hydrophilic and triturate to form gel.

Comments:

• Smooth, non-gritty, off-white gel.

PHLOJEL®: Ibuprofen (IBP)

Strength: 10 – 20% w/w

Equipment: Mortar & Pestle

Procedure:

• Triturate IBP in mortar.

• Add PHLOJEL® Organic and disperse.

• Add cooled PHLOJEL® Hydrophilic and triturate to gel.

Comments:

• Produces a thick, yellowish, non-gritty gel.

PHLOJEL®: 5% Lidocaine, 7.5% Ketoprofen, 5% Amitriptyline

Equipment: Mortar & Pestle, Slab & Spatula

Procedure:

• Pre-mix PHLOJEL® in mortar.

• Levigate lidocaine with alcohol.

• Add amitriptyline and ketoprofen. Levigate thoroughly.

• Incorporate into PHLOJEL® on slab.

Comments:

• Off-white, creamy, smooth on application.

PHLOJEL®: Gabapentin (GPN)

Strength: 5%

Equipment: Mortar & Pestle

Procedure:

• Levigate GPN with minimal alcohol.

• Add PHLOJEL® Organic and disperse.

• Add cooled PHLOJEL® Hydrophilic while triturating.

Comments:

• Produces a smooth, grit-free gel.

PHLOJEL®: 5% Ketoprofen, 5% Ketamine, 2% Carbamezapine, 2% Amitriptyline

Equipment: Mortar & Pestle

Procedure:

• Levigate ketoprofen and carbamezapine with alcohol.

• Add ketamine and amitriptyline and levigate.

• Add PHLOJEL® Organic and disperse.

• Add chilled PHLOJEL® Hydrophilic and triturate to uniformity.

Comments:

• May be thin—ideal for droplet dosing.

• Use Transcutol if possible.

• Can alternatively be compounded on slab using pre-mixed PHLOJEL®.

PHLOJEL®: 2% Cyclobenzaprine HCl, 10% Ketoprofen, 10% Lidocaine HCl

Procedure:

• Levigate ketoprofen and lidocaine with alcohol.

• Add cyclobenzaprine HCl and blend.

• Gradually incorporate into pre-mixed PHLOJEL®.

Comments:

• Final product is pale yellow and non-gritty.

PHLOJEL®: 10% Ketoprofen, 10% Gabapentin, 10% Lidocaine

Equipment: Mortar & Pestle

Procedure:

• Triturate all powders with minimal alcohol.

• Add equal amount of pre-mixed PHLOJEL® and triturate.

• Add remainder and mix well. Refrigerate.

Comments:

• Runny; firms up when chilled.

• Liquefies on skin contact.

PHLOJEL®: 5% Ketamine, 10% Ketoprofen, 10% Lidocaine HCl

Equipment: Mortar & Pestle

Procedure:

• Triturate and blend powders.

• Add alcohol to form paste.

• Add half PHLOJEL® PM, triturate.

• Add remainder and mix until smooth.

Comments:

• Pale yellow, non-gritty final gel.