Hair

Example 4

The following formulations were stored at either 25° C. or 45° C. and stability was evaluated visually, as set forth in the following table.

Example 2

The hair used was dark brown European hair, in switches of 5 g weight and 6 inch length.

The hair was treated with Composition A as follows:—

Hair was first treated with a cleansing shampoo using the following method:—

The hair fibres were held under running water for 30 seconds, shampoo applied at a dose of 0.1 ml of shampoo per 1 g of hair and rubbed into the hair for 30 seconds. Excess lather was removed by holding under running water for 30 seconds and the shampoo stage repeated. The hair was rinsed under running water for 1 minute.

The wet hair was then treated with Conditioner A using the following method:—

Conditioner was applied to the wet hair at a dose of 0.2 ml of conditioner per 1 g of hair and massaged into the hair for 1 minute. The hair was rinsed under running water for 1 minute and excess water removed.

EXAMPLE 1

• • 1. Dutasteride was dissolved in ethanol
  • 2. Medium chain triglycerides and castor oil was added to contents of step 1 to form the solution.
  • 3. The above solution was filled into suitable containers.

The hair growth and hair thickness measurement of was conducted in Wistar rats. Wistar rats was divided into groups, each group having 13 animals. The study on the Wistar rats was conducted for 21 days. On day “0” of the study, fur over and around the flank organs of Wistar rats was shaved with electric clippers and the area of 2×2 cm was used for topical application of dutasteride compositions of examples 2 to 13 at a dose of 100 μl/kg of example 2 to Example 13 along with the compositions of reference example 1 (Finasteride oral at a dose of 0.1 mg/kg) for a period of 21 days once daily (every day between 10 and 11 pm). 100 μl of 1% testosterone was injected subcutaneously daily for 21 days (at 9 am every day) and effect (hair growth and thickness) was evaluated on 22^nd day after sacrificing the animals. The normal control of shaved rats (without the administration of testosterone) was placed with a group consisting of 13 animals.

The change in hair growth was measured by visual scoring (hair growth score) on the 13 animals of each group and the mean was calculated. The visual scoring was calculated based on following parameters

• • Score 0: no hair growth observed
  • Score 1: less than 20% growth observed
  • Score 2: 20% to less than 40% growth observed
  • Score 3: 40% to less than 60% growth observed
  • Score 4: 60% to less than 80% growth observed
  • Score 5: 80% to 100% growth

The visual scoring of mean of 13 animals in each group treated with compositions of example 2 to 13 along with reference oral finasteride and normal control was depicted in Table 7.

The hair thickness was measured by Caslite hair analysing instrument attached to microscope at 200× magnification and results of hair thickness (μm) in each group treated with compositions of example 2 to 13 along with reference oral finasteride and normal control was depicted in Table 7.

The data in the Table 7 shows the hair growth score and hair thickness increased significantly in the Wistar rats of example 2 to 4, most preferably the composition of example 3 consisting of Dutasteride 0.022 wt % (equivalent to 0.02% w/v), Castor Oil 40 wt %, Medium chain triglycerides 30 wt % and Ethanol: qs to 100 wt % (about 30 wt %) has highest hair growth score and hair thickness when compared to the other formulations. The rapid onset of the effects of the above described composition for topical application of the present invention can significantly improve the treatment compliance. That is, in case of the conventional preparations (finasteride oral) the onset of effects is similar to that of the formulation as disclosed in example 3 at the reduced dosage with topical administration and has little side-effects, when compared to the oral finasteride.

Example 1

In comparative example 1, Finasteride active ingredient was dissolved to prepare compositions comprising the oral medication using the following ingredients as shown in Table 6.

Oral Finasteride medication administered in rats at 0.1 mg/kg corresponds to 1 mg human dose.