Current topical minoxidil (MXD) formulations involve an unpleasant organic solvent which causes patient incompliance in addition to side effects in some cases. Therefore, the objective of this work was to develop an MXD formulation providing enhanced follicular delivery and reduced side effects. Oleic acid, being a safer material, was utilized to prepare the nanovesicles, which were characterized for size, entrapment efficiency, polydispersity index (PDI), zeta potential, and morphology. The nanovesicles were incorporated into the emugel Sepineo® P 600 (2% w/v) to provide better longer contact time with the scalp and improve physical stability. The formulation was evaluated for in vitro drug release, ex vivo drug permeation, and drug deposition studies. Follicular deposition of the vesicles was also evaluated using a differential tape stripping technique and elucidated using confocal microscopy. The optimum oleic acid vesicles measured particle size was 317 ± 4 nm, with high entrapment efficiency (69.08 ± 3.07%), narrow PDI (0.203 ± 0.01), and a negative zeta potential of −13.97 ± 0.451. The in vitro drug release showed the sustained release of MXD from vesicular gel. The skin permeation and deposition studies revealed superiority of the prepared MXD vesicular gel (0.2%) in terms of MXD deposition in the stratum corneum (SC) and remaining skin over MXD lotion (2%), with enhancement ratios of 3.0 and 4.0, respectively. The follicular deposition of MXD was 10-fold higher for vesicular gel than the control. Confocal microscopy also confirmed the higher absorption of rhodamine via vesicular gel into hair follicles as compared to the control. Overall, the current findings demonstrate the potential of oleic acid vesicles for effective targeted skin and follicular delivery of MXD.

Objectives: Dabrafenib is used as an active pharmaceutical ingredient acts as an inhibitor of the associated enzyme B-Raf, which plays a role in the regulation of cell growth. In the current study, we focused on developing a robust, highly sensitive and stabilityindicating RP-UPLC method for estimation of DBR and its degradation products for the very first time. A stress study has been performed to demonstrate the stability-indicating capability of the method. Materials and Methods: Chromatographic separation was achieved using advanced UPLC technology with high resolution on Acquity BEH C-18 (100 mm × 2.1 mm, 1.8 μm) column using a mobile phase composed of orthophosphoric acid and methanol with very less consumption of solvents results in an eco-friendly method. Analysis was performed at 225 nm detector wavelength with 5 μL of injection volume and 0.3 mL min -1 of flow rate. Results: Forced degradation study was performed under hydrolytic (acid, alkali and neutral), oxidative, photolytic and thermal degradation as per ICH Q1 (R2) guidelines. The optimized method was observed to be linear in the concentration range of 12.5 to 125ng mL -1 with R 2 value of 1.0000. Conclusion: This is the first very sensitive stability-indicating UPLC method capable of separating dabrafenib and its ten degradation products at the nanogram (ng) level. The method was validated as stated by ICH guidelines.

Alopecia areata is a common, chronic inflammatory disease, characterized by patchy hair loss on the scalp, affecting about 2.1% of world population. Presently, minoxidil has been used for treatment of alopecia as topical lotion, but associated with many drawbacks like systemic side effects and low contact time with skin. Therefore, in the present work, minoxidil gel was prepared using a novel copolymer, Sepineo P 600 to overcome these drawbacks. The prepared gel was characterized for pH, drug content, viscosity, spreadability, skin adhesivity, occlusivity, in vitro drug release, ex vivo skin permeation, stability and finally for skin corrosivity. The drug content of the finalized gel was found to be 99.80 ± 0.82%. The formulation showed good spreadability, occlusivity, adhesiveness and viscosity. In vitro release studies showed that the drug release from prepared gel followed matrix release pattern as compared to lotion. Mathematical modelling of the drug release data suggested Higuchi release model. The formulated minoxidil gel was found to be non-corrosive and stable when subjected to accelerate as well as real time stability studies. Overall, the minoxidil gel formulation was suitable for skin application and can be an effective dosage form for the treatment of Alopecia areata.

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