On the issue of the effectiveness and bioequivalence of isotretinoin Lidose

BACKGROUND: Acne is one of the most common dermatoses. The most effective drug for the treatment of severe forms of acne is systemic isotretinoin, which affects all links in the pathogenesis of acne. The article presents scientific data on the innovative drug Aknecutan, which uses the patented Lidose technology in its production. The use of isotretinoin in the composition of innovative product with Lidose technology makes it possible to reduce the amount of isotretinoin taken by the patient by 20% without compromising the therapeutic effectiveness of the drug. AIM: to analyze comparative studies of bioavailability and relevant pharmacokinetic parameters, which made it possible to prove that the initial dosages of 8 and 16 mg with Lidose technology are bioequivalent to dosages of 10 and 20 mg of the usual form of isotretinoin. MATERIALS AND METHODS: Over the past 7 years, 1044 patients have received acne treatment for moderate to severe acne (651; 62.4% women and 393; 37.6% men) in a daily dose of 0.4–0.8 mg per 1 kg of body weight with a total dose of the drug ― 100–120 mg/kg per course of therapy. RESULTS: After therapy, clinical remission was achieved in all patients, which required from 7 to 12 months of treatment, depending on the daily dose of the drug. Among the side effects in all patients, cheilitis and retinoic dermatitis of the face were noted, which were completely resolved when using moisturizers and sticks. An increase in liver enzymes, triglycerides and lipoproteins was noted in 5–10% and did not exceed 20–30% of the norm and did not require discontinuation of therapy. At the end of treatment, these indicators returned to normal. Other side effects were extremely rare. Relapses of the disease are most often caused by a low total dose of the drug or the presence of endocrinological and gynecological diseases. CONCLUSION: Thus, innovative product with Lidose technology is one of the most highly effective and safe systemic retinoids for the treatment of moderate to severe acne. Comparative studies of bioavailability and corresponding pharmacokinetic parameters have demonstrated the bioequivalence of isotretinoin in the composition of innovative product with Lidose technology, which fully corresponds to that in the original preparation.