11. Cunliffe WJ, Norris JFB. Isotretinoin–An explanation for its long-term benefit. Dermatology. 1987;175(Suppl. 1):133-137.
12. Administration FaD. Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). 40 ed. US Department of Health and Human Services; 2020.
13. Vanderbist F, Servais C, Baudier P. Pharmaceutical semi-solid composition of isotretinoin. Google Patents; 2008.
14. Vanderbist F, Servais C, Baudier P. Pharmaceutical semi-solid composition of isotretinoin. Google Patents; 2013.
15. Absorica (isotretinoin) [package insert]. Princeton, New Jersey: Ranbaxy Laboratories.
16. Webster GF, Leyden JJ, Gross JA. Comparative pharmacokinetic profiles of a novel isotretinoin formulation (isotretinoin-Lidose) and the innovator isotretinoin formulation: a randomized, 4-treatment, crossover study. J Am Acad Dermatol. 2013;69(5):762-767.
17. Del Rosso JQ, Gold LS, Segal J, Zaenglein AL. An open-label, phase IV study evaluating lidose-isotretinoin administered without food in patients with severe recalcitrant nodular acne: low relapse rates observed over the 104- week post-treatment period. J Clin Aesthet Dermatol. 2019;12(11):13.
18. Madan S, Kumar S, Segal J. Comparative Pharmacokinetic profiles of a novel low-dose micronized-isotretinoin 32 mg formulation and Lidoseisotretinoin 40 mg in fed and fasted conditions: two open-label, randomized, crossover studies in healthy adult participants. Acta Derm Venereol. 02 2020;100(4):adv00049. doi:10.2340/00015555-3381
19. Savla R, Browne J, Plassat V, Wasan KM, Wasan EK. Review and analysis of FDA approved drugs using lipid-based formulations. Drug Dev Ind Pharm. Nov 2017;43(11):1743-1758. doi:10.1080/03639045.2017.1342654
20. Madan HK, Venkateshwaran R, Madan S, Kochhar R. Low dose oral pharmaceutical composition of isotretinoin. Google Patents; 2017.
21. Choudhary S, Gupta L, Rani S, Dave K, Gupta U. Impact of dendrimers on solubility of hydrophobic drug molecules. Front Pharmacol. 2017;8:261.
22. Blagden N, de Matas M, Gavan PT, York P. Crystal engineering of active pharmaceutical ingredients to improve solubility and dissolution rates. Adv Drug Deliv Rev. 2007;59(7):617-630.
23. Webster GF, Leyden JJ, Gross JA. Results of a phase III, double-blind, randomized, parallel-group, non-inferiority study evaluating the safety and efficacy of isotretinoin-Lidose in patients with severe recalcitrant nodular acne. J Drugs Dermatol. 2014;13(6):665-670.
24. Rampersaud GC, Pereira MA, Girard BL, Adams J, Metzl JD. Breakfast habits, nutritional status, body weight, and academic performance in children and adolescents. J Am Diet Assoc. 2005;105(5):743-760.
25. Deshmukh-Taskar PR, Nicklas TA, O'Neil CE, Keast DR, Radcliffe JD, Cho S. The relationship of breakfast skipping and type of breakfast consumption with nutrient intake and weight status in children and adolescents: The National Health and Nutrition Examination Survey 1999-2006. J Am Diet Assoc. 2010;110(6):869-878.
26. Isotretinoin survey. Newtown, Pennsylvania: Encuity Research. Interim analysis presented at Winter Clinical Dermatology Meeting, Del Rosso JQ; Kona, Hawaii; January 19, 2014.
12. Administration FaD. Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). 40 ed. US Department of Health and Human Services; 2020.
13. Vanderbist F, Servais C, Baudier P. Pharmaceutical semi-solid composition of isotretinoin. Google Patents; 2008.
14. Vanderbist F, Servais C, Baudier P. Pharmaceutical semi-solid composition of isotretinoin. Google Patents; 2013.
15. Absorica (isotretinoin) [package insert]. Princeton, New Jersey: Ranbaxy Laboratories.
16. Webster GF, Leyden JJ, Gross JA. Comparative pharmacokinetic profiles of a novel isotretinoin formulation (isotretinoin-Lidose) and the innovator isotretinoin formulation: a randomized, 4-treatment, crossover study. J Am Acad Dermatol. 2013;69(5):762-767.
17. Del Rosso JQ, Gold LS, Segal J, Zaenglein AL. An open-label, phase IV study evaluating lidose-isotretinoin administered without food in patients with severe recalcitrant nodular acne: low relapse rates observed over the 104- week post-treatment period. J Clin Aesthet Dermatol. 2019;12(11):13.
18. Madan S, Kumar S, Segal J. Comparative Pharmacokinetic profiles of a novel low-dose micronized-isotretinoin 32 mg formulation and Lidoseisotretinoin 40 mg in fed and fasted conditions: two open-label, randomized, crossover studies in healthy adult participants. Acta Derm Venereol. 02 2020;100(4):adv00049. doi:10.2340/00015555-3381
19. Savla R, Browne J, Plassat V, Wasan KM, Wasan EK. Review and analysis of FDA approved drugs using lipid-based formulations. Drug Dev Ind Pharm. Nov 2017;43(11):1743-1758. doi:10.1080/03639045.2017.1342654
20. Madan HK, Venkateshwaran R, Madan S, Kochhar R. Low dose oral pharmaceutical composition of isotretinoin. Google Patents; 2017.
21. Choudhary S, Gupta L, Rani S, Dave K, Gupta U. Impact of dendrimers on solubility of hydrophobic drug molecules. Front Pharmacol. 2017;8:261.
22. Blagden N, de Matas M, Gavan PT, York P. Crystal engineering of active pharmaceutical ingredients to improve solubility and dissolution rates. Adv Drug Deliv Rev. 2007;59(7):617-630.
23. Webster GF, Leyden JJ, Gross JA. Results of a phase III, double-blind, randomized, parallel-group, non-inferiority study evaluating the safety and efficacy of isotretinoin-Lidose in patients with severe recalcitrant nodular acne. J Drugs Dermatol. 2014;13(6):665-670.
24. Rampersaud GC, Pereira MA, Girard BL, Adams J, Metzl JD. Breakfast habits, nutritional status, body weight, and academic performance in children and adolescents. J Am Diet Assoc. 2005;105(5):743-760.
25. Deshmukh-Taskar PR, Nicklas TA, O'Neil CE, Keast DR, Radcliffe JD, Cho S. The relationship of breakfast skipping and type of breakfast consumption with nutrient intake and weight status in children and adolescents: The National Health and Nutrition Examination Survey 1999-2006. J Am Diet Assoc. 2010;110(6):869-878.
26. Isotretinoin survey. Newtown, Pennsylvania: Encuity Research. Interim analysis presented at Winter Clinical Dermatology Meeting, Del Rosso JQ; Kona, Hawaii; January 19, 2014.
AUTHOR CORRESPONDENCE
April W. Armstrong MD MPH armstrongpublication@gmail.com
