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  • Clindamycin phosphate 1.2%- tretinoin 0.025% gel: vehicle characteristics, stability, and tolerability.

Clindamycin phosphate 1.2%- tretinoin 0.025% gel: vehicle characteristics, stability, and tolerability.

Cutis (2008-06-12)
James Q Del Rosso, Waranush Jitpraphai, Sanjay Bhambri, Saira Momin
ABSTRACT

An aqueous gel formulation containing solubilized clindamycin phosphate 1.2% and a stable combination of both solubilized and crystalline tretinoin 0.025% (clin/tret) has been evaluated in 3 pivotal phase 3 studies, among other studies including a 52-week trial. The pivotal studies enrolled 4550 participants 12 years and older with mild, moderate, and severe acne vulgaris. The combination clin/tret gel was effective in reducing both inflammatory and noninflammatory lesions and was well-tolerated. This article reviews important vehicle characteristics of the combination gel as well as formulation stability and tolerability data that are potentially clinically relevant.

MATERIALS
Product Number
Brand
Product Description

Supelco
Tretinoin, Pharmaceutical Secondary Standard; Certified Reference Material
Tretinoin, European Pharmacopoeia (EP) Reference Standard
USP
Tretinoin, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Clindamycin 2-phosphate, aminoglycoside antibiotic
Clindamycin phosphate, European Pharmacopoeia (EP) Reference Standard
USP
Clindamycin phosphate, United States Pharmacopeia (USP) Reference Standard
Sigma-Aldrich
Retinoic acid, ≥98% (HPLC), powder
Supelco
Clindamycin Phosphate, Pharmaceutical Secondary Standard; Certified Reference Material