Dermatological Formulation

 Innovative Topical Anti Acne Formulation

- comprising of salicylic acid and tetracycline in therapeutic doses

Acne is one of the most common dermatoses affecting 30 – 60 % of the adolescents . Member of Farmavita.Net is offering licensing, contract formulation and/or collaborative research related to innovative dermatological  formulations. 

Etiology

Acne is one of the most common of dermatoses, affecting 30 – 60 % of the adolescents Etiological factors attributed to causation of acne is the increased androgenic activity leading to increase in sebum  production this leads to increased microbial activity around the follicle which leads to keratinization  and subsequent inflammation and comedo formation, the hallmark of acne . 

Clinically acne is typed as mild, moderate and severe according to the type and number all this is important because treatment modality depends on typing. Lesions of acne are macule papule ,pustule or nodule in very extreme cases we get cyst and sinuses . 

Present day Anti Acne armamentarium and rationality of their use:

Method and choice of treatment of acne depends on severity of Acne and also its type. Mild to moderate in other words the type I &II the choice is topical alone or combined with systemic antibiotics, more severe forms demand more specialized therapy which may include topical therapy  along with systemic antibacterials and hormones. 

As can be appreciated from the foregoing that  the changes those occur in Acne  are keratin plug formation and inflammation both due to bacterial floral activity deep down the hair follicle, thus any  topical treatment should be directed towards correction of these factors. It is widely accepted now that combination therapy is better than monotherapy because of multi factorial eitiology of acne, this may be achieved only when we  combine a suitable keratolytic and  an  antibacterial agent .

Several attempts have been made to combine pharmacologically active ingredients having these properties  one having keratolytic effect and the second an antibacterial agent  but with   limited results.  One such example is benzoyl peroxide in combination with erythromycin , since benzoyl peroxide is an oxidizing agent it reduces the effects of  the antibiotic on storage,  thus we find that Benzamycin Gel (Dermik Lab.) comprising of 5% Benzoyl Peroxide and erythromycin rapidly looses its action on storage at ambient temperature as such has to be stored in refrigerator and this is certainly a limiting factors more so in  developing countries  where majority of population do not have refrigerators at home Another preparation is Clindoxy ® Gel which contains clindamycin and benzoyl peroxide in 1: 5 ratio this product also has to be refrigerated and the cool gritty feeling on application may not be acceptable to many. Considering  other kearatolytics we have at our disposal are salicylic acid, azelic acid, lactic acid, retinoic acid and its newer derivatives like tazarotene and adepelene .

Tretinoin has been introduced for over 4 decades now ,its drawback is well known initially it was introduced in  0.1% it was shortly noticed that it produces brisk peeling and the pharmaceutical started reducing the concentration to achieve the desired peeling effect and as of today it is being used at 0.05 % and 0.025%, even at the level of 0.05%  causes inflammation in many as such dermatologists are   hesitant to use this in large section of patients, this photo irritant effect is of high concern in a tropical countries and dermatologist are always hesitant in using this drug, concentration of 0.025% is low enough to have the desired peeling effect. Its newer derivatives have been introduced lately and we have to wait for results to come.

Retinoic acid when used in combination with antibiotics like clindamycin does not give the desired results.   

Salicylic Acid  still remains the choice and it is a FDA approved OTC product when used up to 2% concentration, however ,as acne is a multi-factor origin the optimization of therapy  can logically be achieved by  combining of  keratolytic like salicylic acid and an anti bacterial like tetracycline or an another antibiotic like erythromycin.

To meet these challenges a formulation has been developed comprising of salicylic acid and  tetracycline which is certainly a step towards optimization of topical anti acne therapy.Tetracycline may be substituted by erythromycin or clindamycin depending on choice. Companies interested in licensing, contract formulation and/or collaborative research may contact us.