INTRODUCTION
Acne vulgaris (AV) is a chronic inflammatory skin condition that affects a majority of adolescents and young adults1,2 and is associated with many adverse physical and psychological effects on quality of life.1,3 Oral isotretinoin (13-cis-retinoic acid) can induce complete or near-complete resolution of AV in most patients, with prolonged clearance after completion of therapy; it is considered to be the most effective treatment for severe nodular AV and is the only therapy shown to consistently provide long-term AV clearance after completion of a recommended course of therapy.1,4 Due to its poor aqueous solubility, isotretinoin has historically required ingestion with food -- specifically a high-fat meal with each dose -- to ensure optimal absorption and consistent plasma concentrations of isotretinoin.5,6 This makes patient adherence a concern, particularly in adolescents and young adults, who often exhibit inconsistent eating patterns such as skipping breakfast,7-9 and who are most often the recipients of treatment for AV. Failure to adhere to recommendations to ingest each dose of isotretinoin with an adequate high-fat meal to promote drug absorption may result in lower cumulative exposure to isotretinoin over a course of therapy, which may adversely impact the likelihood of long-term remission.1,10
A formulation containing micronized isotretinoin diffused in a lipid carrier system is approved for the treatment of severe recalcitrant nodular AV in nonpregnant patients 12 years of age and older with multiple inflammatory nodules.11,12 Micronization, together with solubilization of isotretinoin in a lipid matrix, significantly improves the bioavailability and absorption of oral isotretinoin, thereby eliminating the dependence on high-fat, high-calorie food intake and allowing for administration without regard to meals with a lower administered dose compared with conventional isotretinoin formulations.11,12 The dosage of micronized isotretinoin as stated in the approved product labeling is 0.4 to 0.8 mg/kg/day
A formulation containing micronized isotretinoin diffused in a lipid carrier system is approved for the treatment of severe recalcitrant nodular AV in nonpregnant patients 12 years of age and older with multiple inflammatory nodules.11,12 Micronization, together with solubilization of isotretinoin in a lipid matrix, significantly improves the bioavailability and absorption of oral isotretinoin, thereby eliminating the dependence on high-fat, high-calorie food intake and allowing for administration without regard to meals with a lower administered dose compared with conventional isotretinoin formulations.11,12 The dosage of micronized isotretinoin as stated in the approved product labeling is 0.4 to 0.8 mg/kg/day
