Gamma oryzanol niosomal gel for skin cancer: formulation and optimization using quality by design (QbD) approach

AAPS Open

Aditi Bariya¹  Shital Butani²  Ankit Gotecha²  Shital Panchal²  Dolly Jetha²  Amarjitsing Rajput³  Harsh S. Shah⁴ 

[1] Arihant School of Pharmacy Education and Research, Adalaj, 382421, Gandhinagar, Gujarat, India;Department of Pharmaceutical Technology, Institute of Pharmacy, Nirma University, 382481, Ahmedabad, Gujarat, India;Department of Pharmaceutics, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Erandwane, 411038, Pune, Maharashtra, India;J-Star Research Inc., 08512, Cranbury, NJ, USA;

关键词: Niosomes;    Niosomal gel formulation;    Quality by design;    Quality target product profile;    Risk assessment;   

DOI  :  10.1186/s41120-021-00041-2

来源: Springer

【 摘 要 】

Skin cancer is fifth most diagnosed disease in human population due to ultraviolet radiation (UV) exposure. Gamma oryzanol (OZ) is a natural antioxidant, and it also has skin anti-aging properties. OZ is naturally found in rice bran oil. The main aim of the present work was to optimize OZ niosomal formulation using quality by design approach including one variable at a time and full factorial design. Niosomes were prepared by solvent injection method and characterized for size, polydispersity index, drug entrapment, and transmission electron microscopy. The optimized batch obtained at X1 [drug to span 60 molar ratio (1:5)], X2 [volume of hydration (75 mL)], and X3 [stirring speed (2500 rpm)] to Y1 [average vesicle size (196.6 nm)] and Y2 [entrapment efficiency (78.31%)] as dependent variables. The optimized OZ noisomes were formulated by niosomal gel to provide improved physicochemical stability upon topical application against UV. The niosomal gel was characterized using pH meter, viscometer, Draize test for skin irritancy, ex vivo permeation studies, and stability studies. Ex vivo permeation studies of OZ niosomal gel not only showed fourfold higher permeation but also exhibited better drug retention in dermal layers of skin as compared to OZ gel. Quality Target Product Profile of OZ niosomal formulation was generated. Risk analysis of optimized OZ gel suggested most critical quality attributes (CQAs) and critical process parameters (CPPs) to be characterized as low risk. Thus, γ-oryzanol niosomal gel for topical use can serve as a promising prophylactic treatment in skin cancer, and the developed prototype formulation can be further extended to future newly discovered drugs with similar characteristics.Graphical abstract

【 授权许可】

CC BY