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![Smile](https://www.baldtruthtalk.com/images/smilies/smile.png)
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.
![Smile](https://www.baldtruthtalk.com/images/smilies/smile.png)
So lets get down to business
![Smile](https://www.baldtruthtalk.com/images/smilies/smile.png)
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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