Comparative studies of the specific activity of soft dosage forms minoxidil for trichological practice
Authors: Hladyshev V. V. , Kharaponova O. B. , Diudiun A. D. , Pukhalska I. O. , Hladysheva S. A. , Kurinnyi A. V. , Lysianska H. P. 
Published: April 2023

The treatment and prevention of hair loss have been a serious aesthetic problem for the population for a long time due to the widespread occurrence of the condition and its undesirable medical and social consequences. The pharmacotherapeutic options for trichological practice are very limited, and the effectiveness of many of these drugs is small or questionable. The peripheral vasodilator minoxidil is one of the few medicinal substances that has been proven to stimulate hair growth. However, the number of minoxidil preparations allowed by the Ministry of Health for use in Ukraine is minimal and mainly represented by rare dosage forms for external use. Considering the above, the employees of the Department of Medicines Technology at Zaporizhzhia State Medical University have proposed rational formulations and technologies for two new soft dosage forms of minoxidil – a 2 % cream for external use based on an emulsion, and a shampoo in gel form – based on complex physical-chemical, pharmaco-technological, rheological, and biopharmaceutical research. These formulations are intended to stabilize hair growth and restore hair coverage in men and women suffering from androgenic alopecia.
The aim of this research is to study the specific activity of the proposed topical dosage forms of minoxidil.
Materials and methods. Experimental cream with 2 % minoxidil on an emulsion carrier and a gel-like shampoo containing 1 % minoxidil combined with phytoextracts of hops and burdock, as well as corresponding placebo compositions, were used as objects of preclinical studies. The compositions of the topical minoxidil pharmacotherapeutic agents are scientifically based, ensuring their optimal pharmacotechnological, biopharmaceutical, and consistent consumer properties. The study of the specific activity of soft medicinal forms of minoxidil for external use was carried out by evaluating their growth-stimulating and follicle-protective activity. “Pilfood Bosnalek” spray for external use (Bosnalijek, Bosnia and Herzegovina), containing 2 % minoxidil, was used as a reference drug when studying the growth-stimulating effect of 2 % cream for external use with minoxidil. The reference drug in the study of the similar activity of the gel-like shampoo “Trichlomine” was the shampoo against hair loss “Dove” (Unilever, Germany).
Results. It has been found that a 2 % minoxidil cream for topical use, when used together with the reference drug “Pilfood Bosnalek” (Bosnalijek, Bosnia and Herzegovina), has a significant hair growth-stimulating effect, which statistically significantly increases hair growth in experimental animals from as early as 3–4 days of use. The shampoo “Trichlomine” also has a significant effect on hair growth in experimental animals, with results observed from 3–4 days of use. Furthermore, the strength of the hair growth-stimulating effect observed from the use of “Trichlomine” shampoo significantly exceeds that of the reference “Dove” shampoo (Unilever, Germany). These results demonstrate the presence of significant follicle-stimulating activity in the tested minoxidil preparations for treating experimental alopecia and their positive effects on the weight and structure of laboratory animal fur. The follicle-protective activity of experimental minoxidil dosage forms (2 % cream and gel-like shampoo) was also experimentally confirmed, due to the regulation of various metabolic pathways in the dermis. The use of 2 % minoxidil cream and comparison preparations (“Dove” shampoo and “Pilfood Bosnalek” spray) did not result in the normalization of the investigated indicators of dermal energy metabolism. However, a positive effect of “Trichlomine” shampoo was found, which is associated with the presence of a plant antioxidant complex in the pharmacotherapeutic agent and its potentiating effect with minoxidil.
Conclusions. It was found that the application of soft dosage forms of minoxidil (2 % emulsion-based cream and 1 % gel-based shampoo) exhibited pronounced growth-stimulating and follicle-protective activity in the model of experimental alopecia in white rats. At the same time, it was established that the cream with minoxidil 2 % for external use and the reference spray for external use “Pilfood Bosnalek” (Bosnalijek, Bosnia and Herzegovina) have a significant statistically comparable growth-stimulating effect. The strength of the growth-stimulating effect recorded from the use of the “Trichlomine” shampoo significantly exceeded the effect of the reference shampoo “Dove” (Unilever, Germany). It was found that both experimental medicinal forms of minoxidil (2 % cream and gel-like shampoo) had a follicle-protective effect by normalizing various links of dermis metabolism. The most pronounced effect in this regard was recorded in the shampoo “Trichlomine”, which contained not only minoxidil but also plant-antioxidant complexes. Application of 2 % cream with minoxidil, as well as reference drugs (spray “Pilfood Bosnalek” and shampoo “Dove”), did not have a reliable effect on the indicators of energy exchange of the dermis studied.