Formulation used as microemulsions, gel-based emulsion or roll-on stick in system for topical application, and drug delivery, comprises drug, oil, surfactant, co-surfactant, stabilizer, preservative and aqueous vehicle, where drug is Clobetasol propionate, and surfactant is Tween 20
	SHEERAZ A S; AGGARWAL N N; SHENOY M B; GHATE V; BIJU P
	2023-07-20
专利权人	UNIV YENEPOYA (UYYE-Non-standard)
申请日期	2023-07-20
专利号	IN202341048782-A
成果简介	NOVELTY - Formulation comprises 0.001 to 5.0 wt.% drug, 0.05-35.0 wt.% oil, 0.01-20.0 wt.% surfactant, 0.01 to 15.0 wt.% co-surfactant, 0.01-15.0 wt.% stabilizer, 0.001-5.0 wt.% preservative and 100.0 wt.% aqueous vehicle, where drug is Clobetasol propionate, oils are oleic acid and caprylic/capric triglycerides, surfactant is Tween (RTM: Polysorbate surfactant) 20, co-surfactant is polyethylene glycol (PEG-400), stabilizer is gellan gum, preservative is benzyl alcohol, and aqueous vehicle is water. USE - Formulation used as microemulsions, gel-based emulsion or roll-on stick (claimed) in system for topical application, and drug delivery. ADVANTAGE - The formulation viscosity is 624 ± 2.67 megapascal/second (mPa.S), spreadability is 3.31 cm, absorbance at 241nm indicative of the Clobetasol content, pH of optimized microemulsion is 6.62, and the Clobetasol propionate content in the microemulsion formulation is 620 μg/mL, and FTIR value is in the range of 4000-400 per cm. The emulsifying agent has higher HLB value of 15-20 to stabilize the o/w emulsion and lipid-based carriers to increase the solubility and stability to lipophilic drugs. The topical application of formulation show their excellent role in dosage form design, stability, controlled drug release pattern, and delivery of the drug to the target place for a longer duration of the period. The formulation sustains drug release, targets the active site, and has minimal residue on the skin surface. The microemulsions provide improved drug penetration into the skin, and medicated roll-on system offers ease of application, increases drug deposition/absorption on the skin and improved user compliance. DETAILED DESCRIPTION - INDEPENDENT CLAIMS are included for: Method of preparation a formulation, which involves: (1) solubilizing Clobetasol propionate in a mixture of oleic acid and caprylic/capric triglycerides; (2) heating at 50℃ to form the oil phase (mixture A); (3) dissolving the emulsifying agents, that are Tween 20 and polyethylene glycol (PEG-400) in a portion of water until a homogeneous solution is formed (mixture B); (4) soaking gellan gum in a portion of water overnight to swell and disperse uniformly; (5) adding gellan gum dispersion gradually to the mixture B while stirring at 500 revolution/minute (rpm), and place on heater to 50℃ (mixture C); (6) dissolving benzyl alcohol in the mixture C to form the aqueous phase (mixture D); (7) adding the oil phase (mixture A) dropwise into the aqueous phase (mixture D), both maintained at 50℃ with continuous stirring at 750 rpm; (8) stirring at high speed is required for making fine sized globules of the oil phase in aqueous phase to increase the permeation of the drug into the epidermis and dermis, breaching the stratum corneum; (9) combining the mixtures uniformly, once the mixtures are combined uniformly, the emulsion is removed from heat and cooled gradually to room temperature, with continuous stirring at 750 rpm; (10) forming of a white creamy emulsion formulation; and (11) filling the formed emulsion into roll-on tubes; and System for drug delivery, which comprises a formulation, roll-on device for delivery of the formulation, where the formulation comprises drug, oil, surfactant, co-surfactant, stabilizer, preservative and aqueous vehicle, and the roll-on device delivers sustain drug release at targets site.
IPC 分类号	A45D-034/04 ; A61K-031/513 ; A61K-039/00 ; A61K-047/10 ; A61P-019/10
国家	印度
专业领域	医药卫生
语种	英语
成果类型	专利
文献类型	科技成果
条目标识符	http://119.78.100.226:8889/handle/3KE4DYBR/21215
专题	中国科学院新疆生态与地理研究所
作者单位	UNIV YENEPOYA (UYYE-Non-standard)
推荐引用方式 GB/T 7714	SHEERAZ A S,AGGARWAL N N,SHENOY M B,et al. Formulation used as microemulsions, gel-based emulsion or roll-on stick in system for topical application, and drug delivery, comprises drug, oil, surfactant, co-surfactant, stabilizer, preservative and aqueous vehicle, where drug is Clobetasol propionate, and surfactant is Tween 20. IN202341048782-A[P]. 2023.

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