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Topical Finasteride 0.1% Foaming Solution 60mL
Hi guys, I can't believe it's almost a year since I posted on this board. Oh how the time flies! I have to say I really missed this place and all the discussions everyone's having. It is definitely a very unique and invaluable community we have here 
Hope you've all been well and haven't allowed hairloss to get the better of you.
So lets get down to business
Firstly, please keep in mind that we designed this formulation for preparation in a compounding pharmacy, so it is much more difficult for a layperson to prepare due to the equipment and ingredients necessary for this particular dosage form.
The second issue I would like to point out is the dose. We based the strength on all the research papers available on Topical finasteride, which showed 0.1% is an effective dose comparable to oral finasteride. My personal view however is that 0.1% is far too potent and almost unnecessary for a topical formulation and will most likely lead to side effects we are desperately trying to avoid. So feel free to reduce it down to 0.05% if you want to be on the safe side. That is what I'm going to be trialing myself. So, finally, here's the formulation:
Ingredient List:
1) Finasteride 0.06g
2) Cetyl Alcohol, NF 0.9g
3) Stearyl alcohol, NF 0.9g
4) Cocamide DEA 3.60g
5) Sodium Lauryl Sulfate 12-13%
6) Potassium sorbate, NF 0.06g
7) Methylparaben, NF 0.06g
8) Alcohol 95% 6mL
9) Purified Water 24mL
10) Purified Water qs to 60mL
11) Hydrochloric acid 10% Solution As required
Preparatory Instructions:
1) Preparatory Step:
A. Prepare a hot water bath
Specifications: Temperature: 75 to 80°C
2) Powder-liquid preparation
A. Incrementally add the Finasteride to the Alcohol 95% and continue to mix until dissolved.
End result: Homogeneous liauid-like solution
3) Aqueous phase preparation:
A. Using the hot water bath sequentially add the following ingredients to the Purified Water (24.0 mL plus processing error adjustments).
-Potassium Sorbate
-Methylparaben
Specifications: Continuouslv mix until all solid particles have completely dissolved.
End result: Homogeneous liquid-like solution.
4) Oil phase preparation:
A. Using the hot water bath combine and mix the following ingredients together to form a homogeneous liquid-like dispersion:
-Cetyl Alcohol
-Stearyl Alcohol
-Cocamide DEA
Specifications: Allow the ingredients to melt together without mixing.
Maintain temperature between 70 to 75°C
End result: Homogeneous liauid-like dispersion.
B. Using the hot water bath incrementally add the homogeneous liquid-like solution (Step 2A) to the homogeneous liquid-like dispersion (Step 4A) and mix until homogenous.
Specifications: Allow the ingredients to melt together without mixing. Maintain temperature between 70 to 75°C
End result: Homogeneous liauid-like dispersion.
5) Phase integration:
A. In the given order, sequentially add the following ingredients to the homogeneous liquid-like solution (Step 3 A).
-Ammonium Lauryl Sulfate 27-28%
-Homogeneous liquid-like dispersion (Step 4B)
Specifications: Continuously mix.
End result: Homogeneous lotion-like dispersion.
B. Once homogeneous, remove the mixture from the heat and continuously mix at low speed until the temperature of the mixture reaches 30 to 35 °C.
End result: Homogeneous liquid-like dispersion.
6) Filling to Volume:
A. Add additional Purified Water to the above mixture to fill to the required batch size (60.0 mL plus processing error adjustments)
Specifications: Continuously mix.
End result: Homogeneous lotion-like dispersion.
7) pH testing:
A. Draw an appropriate amount of the mixture (Step 6A).
B. Test the pH of the sample. It should he between 6.4 and 6.6.
C. If the pH > 6.6, carefully add. in a dropwise fashiou the Hydrochloric Acid 10% solution to the mixture:
1. Draw and transfer 1 or 2 drops of the Hydrochloric Acid 10% solution to the mixture.
2. Stir for at least 5 minutes to evenly disperse the Hydrochloric Acid 10% solution.
3. Re-test the pH.
4. Continue to add the Hydrochloric Acid 10% solution until the pH of 6.4 to 6.6 is obtained. IMPORTANT: Do not allow the pH to drop below 6.4.
8) Product transfer:
Transfer the final product into the tight, light-resistant foam dispensing container.
Estimated Beyond Use date: 30 days after preparation
Storage: Keep at room temperature (below 25 C)
Protect from light
Shake well before use.
Do not allow to come into contact with eyes/nose/ear/mouth.
Hope you've all been well and haven't allowed hairloss to get the better of you. So lets get down to business
Firstly, please keep in mind that we designed this formulation for preparation in a compounding pharmacy, so it is much more difficult for a layperson to prepare due to the equipment and ingredients necessary for this particular dosage form.
The second issue I would like to point out is the dose. We based the strength on all the research papers available on Topical finasteride, which showed 0.1% is an effective dose comparable to oral finasteride. My personal view however is that 0.1% is far too potent and almost unnecessary for a topical formulation and will most likely lead to side effects we are desperately trying to avoid. So feel free to reduce it down to 0.05% if you want to be on the safe side. That is what I'm going to be trialing myself. So, finally, here's the formulation:
Ingredient List:
1) Finasteride 0.06g
2) Cetyl Alcohol, NF 0.9g
3) Stearyl alcohol, NF 0.9g
4) Cocamide DEA 3.60g
5) Sodium Lauryl Sulfate 12-13%
6) Potassium sorbate, NF 0.06g
7) Methylparaben, NF 0.06g
8) Alcohol 95% 6mL
9) Purified Water 24mL
10) Purified Water qs to 60mL
11) Hydrochloric acid 10% Solution As required
Preparatory Instructions:
1) Preparatory Step:
A. Prepare a hot water bath
Specifications: Temperature: 75 to 80°C
2) Powder-liquid preparation
A. Incrementally add the Finasteride to the Alcohol 95% and continue to mix until dissolved.
End result: Homogeneous liauid-like solution
3) Aqueous phase preparation:
A. Using the hot water bath sequentially add the following ingredients to the Purified Water (24.0 mL plus processing error adjustments).
-Potassium Sorbate
-Methylparaben
Specifications: Continuouslv mix until all solid particles have completely dissolved.
End result: Homogeneous liquid-like solution.
4) Oil phase preparation:
A. Using the hot water bath combine and mix the following ingredients together to form a homogeneous liquid-like dispersion:
-Cetyl Alcohol
-Stearyl Alcohol
-Cocamide DEA
Specifications: Allow the ingredients to melt together without mixing.
Maintain temperature between 70 to 75°C
End result: Homogeneous liauid-like dispersion.
B. Using the hot water bath incrementally add the homogeneous liquid-like solution (Step 2A) to the homogeneous liquid-like dispersion (Step 4A) and mix until homogenous.
Specifications: Allow the ingredients to melt together without mixing. Maintain temperature between 70 to 75°C
End result: Homogeneous liauid-like dispersion.
5) Phase integration:
A. In the given order, sequentially add the following ingredients to the homogeneous liquid-like solution (Step 3 A).
-Ammonium Lauryl Sulfate 27-28%
-Homogeneous liquid-like dispersion (Step 4B)
Specifications: Continuously mix.
End result: Homogeneous lotion-like dispersion.
B. Once homogeneous, remove the mixture from the heat and continuously mix at low speed until the temperature of the mixture reaches 30 to 35 °C.
End result: Homogeneous liquid-like dispersion.
6) Filling to Volume:
A. Add additional Purified Water to the above mixture to fill to the required batch size (60.0 mL plus processing error adjustments)
Specifications: Continuously mix.
End result: Homogeneous lotion-like dispersion.
7) pH testing:
A. Draw an appropriate amount of the mixture (Step 6A).
B. Test the pH of the sample. It should he between 6.4 and 6.6.
C. If the pH > 6.6, carefully add. in a dropwise fashiou the Hydrochloric Acid 10% solution to the mixture:
1. Draw and transfer 1 or 2 drops of the Hydrochloric Acid 10% solution to the mixture.
2. Stir for at least 5 minutes to evenly disperse the Hydrochloric Acid 10% solution.
3. Re-test the pH.
4. Continue to add the Hydrochloric Acid 10% solution until the pH of 6.4 to 6.6 is obtained. IMPORTANT: Do not allow the pH to drop below 6.4.
8) Product transfer:
Transfer the final product into the tight, light-resistant foam dispensing container.
Estimated Beyond Use date: 30 days after preparation
Storage: Keep at room temperature (below 25 C)
Protect from light
Shake well before use.
Do not allow to come into contact with eyes/nose/ear/mouth.
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