Isotretinoin (13-cis-Retinoic acid (13-cis-RA)) (INN), it is asynthetic retinoid. In 1982, Isotretinoin was approved as a treatment for severe recalcitrant nodular acne,. There are several generics of isotretinoin soft gelatin capsules available in the pharmaceutical market globally. Availability of various brands of isotretinoin capsules in Saudi drug market today places dermatology physicians in a dilemma. The objective of this study is to compare among the physicochemical properties of four different commercial isotretinoin brands using in vitro tests. The physicochemical equivalence of selected four brands of INN capsules (Roaccutane®, Cureacne®, Xeractan® from local Saudi market and Netlook® from Egypian market), were assessed through the evaluation some tests such as weight variation, weight uniformity (drug content), rupture, disintegration and dissolution for the selected four different brands of soft gelatin capsules. All brands passed all the official tests as prescribed by the USP, all brands were within the limit when tested for weight variation and disintegration time. The drug content of all tested brands was ranged from 90-110%. The rupture test was within the UPS specified values. Additionally, dissolution profile of all tested brands showed a drug release of more than 35% in in the first one hour. This comparative in vitro evaluation study of the teste brands of INN indicate the usefulness, effectiveness and idealness of commercial product. Some variations can be observed as a result of differences in additives used in the capsule formulation manufacturing processes, which may vary from manufacturer to the other. Accordingly, patients can safely switch from one brand to another.
