Department of Chemical Engineering

Preparation of Topical Solution of Minoxidil API For The

Purpose of Hair Regeneration.

Presented By:
Vaibhav Santosh Gaikwad. (Roll No. 14) Co-guided By:
Dipesh Dipak Kadav. (Roll No. 26) Dr. Ankur Chaturvedi
Chaitanya Suresh Warvatkar. (Roll No. 65) Guided By:
Dr. S. J. Kulkarni
 CONTAINTS

 Objective
 Introduction
 Alopecia
 Different gel formulations of minoxidil 5%
 Evaluation study
 Future work
 Conclusion
 References
 OBJECTIVE

 To reduce hair loss and promote regrowth of hair in conditions like

alopecia.
 INTRODUCTION

Minoxidil API (Active Pharmaceutical Ingredient)

It is a vasodilator class of drug that dilates blood vessels and helps grow new hair. It is
available in the market as a topical solution and topical foam formulations.

The active ingredient in Rogaine, minoxidil, redeveloped hair spores and activates the
hair growth cycle. minoxidil topical 2% solution is approved by health Canada and
is proven to reduce hair loss for some men within 12 months, based on clinical studies.
2,4-Diamino-6-piperidinopyrimidine 3-oxide
 ALOPECIA

Alopecia is a disease that happens when the immune system attacks hair spores and
causes hair loss. Hair spores are the structures in skin that form hair.
Alopecia mean hair loss, today 70% males and 30% females are suffering from this
disorder. Loss of hair is the most common problem of modern societies, which create
much economical and psychological effect. Recently, a great effort has been made to
treat hair loss or alopecia.
Minoxidil is hypertensive drug but one of its side effects which act in application of
alopecia. It was suggested that the hair growth by minoxidil was due to increase of
blood flow. Topically applied minoxidil was shown to improve blood flow in human
balding scalp.
 Different gel formulations of Minoxidil 5%
Formulation Code
Sr. No. Ingredients
F1 F2 F3
1 Minoxidil 5 5 5
2 Propylene glycol 15 50 40
3 Ethanol 30 25 20
4 Purified Water 50 20 35
5 Carbopol - - -
6 Menthol - - -
7 Caffeine - - -
8 Onion oil - - -

Minoxidil is not dissolved.

Minoxidil dissolved.
Minoxidil is not completely soluble.
Formulation F1: Minoxidil Is Not Dissolved Formulation F2: Minoxidil Is Dissolved
Formulation F3: Minoxidil Is Not Completely Dissolved
 DECISION

From above three formulations (F1, F2, F3) we decided that the formulation F2 is
suitable for 5% minoxidil solution means 5% minoxidil was dissolved in the mixture of
ethanol: propylene glycol: water in the ratio (50:25:20) and obtain clear mixture
solution. So we decided that we are going to prepare the topical solution of 5%
minoxidil with formulation F2.
 Formulation F2
Procedure
1) 20 ml purified water was taken in 200ml beaker and 0.5 gm Carbopol powder is added carefully into it with
constant stirring for 15-20 min.
2) After proper mixing thick gel type solution is formed.
3) Then 25 ml ethanol (98 % pure) is added into the gel type solution. Due to this viscosity changes
4) After that, 50 ml propylene glycol is added into the solution then we get thick liquid.
5) After that, 5 gm minoxidil was added into the solution and mixed it until minoxidil completely dissolved
(expectation).
6) The minoxidil powder is dissolved after some time and thick viscous gel is obtained.
7) Then, triethanolamine is added into the solution drop by drop to maintain PH up to 7.4
Observations
8) Carbopol is mixed with water forms a thick gel type solution.
9) After adding ethanol and propylene glycol into the gel type solution viscosity of solution decreases.
10) Minoxidil powder is soluble into the solution and forms thick clear viscous gel.
11) After adding triethanolamine drop by drop into the solution to maintain PH of solution up to 7.4 we observed two
phases are formed like white precipitate and after some time we get completely separation of two phases, - one is
clear liquid and other is rubber type solid.
Results & Conclusion
Today we have observed that above formulation or composition is working (suitable) for 5% minoxidil but, after
adding triethanolamine to maintain PH we not get final form of solution.

Before Adding Triethanolamine After Adding Triethanolamine

 Formulation F2

Procedure
1) 20 ml purified water was taken in 200ml beaker.
2) Then 25 ml ethanol (98 % pure) is added into the beaker.
3) After that, 50 ml propylene glycol is added into the solution containing ethanol and water.
4) Then all three components are well mixed.
5) After that, 5 gm minoxidil was added into the solution and mixed it until minoxidil completely dissolved
(expectation).
6) Then, triethanolamine is added into the solution drop by drop to maintain PH up to 7.4
7) Then by adding 0.5 gm Carbopol powder is added carefully into it with constant stirring for 15-20 min solution is
finally gelled.
Observations
8) (ethanol) is mixed with water, it is observed that ethanol is completely soluble in water.
9) After adding propylene glycol into the ethanol - water mixture.
10) 5 gm minoxidil is soluble in above solution.
11) Then by adding Carbopol into solution it is observed that solution is converted into thick gel.
Results & Conclusion
Today we have observed that above formulation or composition is working (suitable) for 5% minoxidil and we got
a final form gel type.

Prepared Gel of Minoxidil

 Formulation Code
Sr. No. Ingredients
F2 F2
1 Minoxidil 5 5
2 Propylene glycol 50 50
3 Ethanol 25 25
4 Purified Water 20 20
5 Carbopol - 0.5
6 Menthol - 0.5
7 Caffeine - 0.1
8 Onion oil - 0.2

Minoxidil is dissolved but we not got gelled.

Minoxidil dissolved and got gelled.

 EVALUATION STUDY

1) Homogeneity
2) Measurement of pH
3) Grittiness
4) Extrudability study
 FUTURE WORK

Evaluation study of drug contain drug content using UV spectrometry.

 CONCLUSION

It is clear from the study that the goal of the research was to stop hair loss and encourage
regrowth of hair in diseases like androgenetic alopecia. According to the observations,
addition of Carbopol as a gelling agent and triethanolamine for pH adjustment required to
follow the proper steps to get the final form of topical solution as a gel. Also, we observe
that solubility of minoxidil is increases with increase in % of propylene glycol and ethanol
and decreases with increasing % of purified water. Gel formulation were prepared with an
intension of regrowth of hair by using (5%) minoxidil with other ingredients. Prepared gel
is tested for the various parameters such as Homogeneity, Measurement of pH, Grittiness,
Extrudability study etc..
 REFERENCES
1. Kaur, Loveleen Preet, Rajeev Garg, and G. D. Gupta. "Topical gels: a review." Research Journal of Pharmacy and Technology 3.1
(2010): 17-24.

2. Parhi, Rabinarayan, Bhaskara Rao Terapalli, and B. B. Teja. "Formulation and in vitro evaluation of minoxidil topical gel." Turk J Pharm
Sci 11.2 (2014): 153-62.

3. Usmania, Usmania, Ajay Bilandi, and Mahesh K. Kataria. "Minoxidil emulgel for androgenic alopecia: a literature review including
patents." International Journal of Pharmaceutics and Drug Analysis 5.3 (2017): 49-58.

4. Al-taie, Alaa R., Myasar M. Al-kotaji, and Hani M. Almukhtar. "Minoxidil in androgenic alopecia: New formulations with Improved
delivery." Iraqi Journal of Pharmacy 18.2 (2022): 53-63.

5. Gupta, Sunil, et al. "Enhanced topical formulation of minoxidil gel for alopecia condition." Int. J. Pharm. Res. Allied Sci 1.1 (2012): 41-
47.

6. Reddy, M. Sreenivasa, S. Mutalik, and G. Veerabhadra Rao. "Preparation and Evaluation of Minoxidil Gels for Topical Application in
Alopecia opical Application in Alopecia." Indian journal of pharmaceutical sciences (2006): 432.

7. Uprit, Shubham, et al. "Preparation and characterization of minoxidil loaded nanostructured lipid carrier gel for effective treatment of
alopecia." Saudi Pharmaceutical Journal 21.4 (2013): 379-385.