Background: Diabetic foot ulcer is an intractable complication of diabetes, characterized by the disturbed inflammatory and proliferative phases of wound healing. Sesamol, a phenolic compound, has been known for its powerful antioxidant, anti-inflammatory, antihyperglycaemic and wound healing properties. The aim of the present study was to develop a sesamol nano formulation and to study its effect on the various phases of the wound healing process in diabetic foot condition. Methods: Sesamol-PLGA (SM-PLGA) nanosuspension was developed using nanoprecipitation method. TEM, in vitro drug release assay and in vivo pharmacokinetic studies were performed for the optimised formulation. Diabetic foot ulcer (DFU) in high fat diet (HFD)fed streptozotocin-induced type-II diabetic animal model was used to assess the SM-PLGA nanosuspension efficacy. SM-PLGA nanosuspension was administered by oral route. TNF-α levels were estimated using ELISA and Western blot analysis was performed to assess the effect on the expression of HSP-27, ERK, PDGF-B and VEGF in wound tissue. Wound reepithelization, fibroblast migration, collagen deposition and inflammatory cell infiltration were assessed by H&E and Masson's trichrome staining. Effect on angiogenesis was assessed by CD-31 IHC staining in wound sections. Results: The optimized SM-PLGA nanosuspension had an average particle size of <300 nm, PDI<0.200 with spherical shaped particles. Approximately 80% of the drug was released over a period of 60 h in in vitro assay. Half-life of the formulation was found to be 13.947 ± 0.596 h. SM-PLGA nanosuspension treatment decreased TNF-α levels in wound tissue and accelerated the collagen deposition. Whereas, HSP-27, ERK, PDGF-B and VEGF expression increased and improved new blood vessels' development. Rapid re-epithelization, fibroblast migration, collagen deposition and reduced inflammatory cell infiltration at the wound site were also observed. Conclusion: Results indicate that sesamol-PLGA nanosuspension significantly promotes the acceleration of wound healing in diabetic foot ulcers by restoring the altered wound healing process in diabetic condition.

The aim of the present study was to formulate a fluconazole cream for the treatment of Candida albicans. The optimized cream formulation was prepared using stearic acid, oleic acid, beeswax and borax. The uniform distribution of the active ingredient fluconazole could be confirmed in all formulated creams. The FC-C-C formulation showed satisfactory spreadability and extrudability. FC-C-C delivered (95.07 ± 15.85)% in only 36 h, and the formulation released the drug by an anomalous diffusion mechanism. The viscosity of FC-C-C was found to be (63.20 ± 0.83) cP. The antifungal study and animal studies confirmed that the prepared formulation is non-irritant and has an enhanced antifungal activity that reduces the side effects of fluconazole. The studies confirm that the prepared formulation may be useful for the treatment of Candida albicans.

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The objective of the present study was to develop a robust, simple, economical and sensitive HPLC-UV method using the “quality-by-design” approach for the estimation of irinotecan (IRI) in marketed formulations. RP-HPLC method was developed by applying Box-Behnken design with Hyper-Clone (Phenomenex®) C18 column (250 × 4.6 mm id, particle size 5 µm, ODS 130 Å) as a stationary phase. Acetonitrile and 20 mmol L−1 potassium phosphate buffer (pH 2.5) containing 0.1 % triethylamine in a ratio of 45:55 % (V/V) was used as a mobile phase. The sample was injected in a volume of 20 µL into the HPLC system. UV detector at 254 nm was used to estimate and quantify IRI. Isocratic elution was opted while the flow rate was maintained at 0.75 mL min−1. The retention time of IRI was found to be 4.09 min. The responses were found to be linear for concentration range of 0.5 to 18.0 µg mL−1 and the coefficient of determination value was found to be 0.9993. Percent relative standard deviation for intra- and inter-day precisions was found in the range of 0.1 to 0.4 %. LOD and LOQ values were found to be 4.87 and 14.75 ng mL−1, resp. Robustness studies confirmed that the developed method is robust with RSD of a maximum 0.1 %. The method is simple, precise, sensitive, robust and economical making it applicable to the estimation of IRI in an injectable formulation.

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Objective of this study was to develop and validate HPLC-UV method for detection of LTG in lipid nanoformulations. HPLC-UV method was developed according to ICH Q2(R1) guidelines. Central composite design was used effectively to optimize and study the effect of buffer strength, flow rate, pH of buffer and mobile phase composition on responses such as tailing factor, peak area, retention time and number of theoretical plates. The 30 mM ammonium formate buffer and acetonitrile (in the ratio 65:35 %v/v) was used as mobile phase in the study. The mobile phase was delivered at the flow rate of 1.0 mL/min. The detection of buffer was performed at 256 nm using UV detector. The drug entrapment of prepared formulation was also determined using developed HPLC method. Retention time of lamotrigine was found to be 3.844 min. The coefficient of determination (r2) value from linearity was found to be 0.9982. Percent relative standard deviation value of precision was found to be within the acceptable range. The estimated LOD and LOQ were found to be 9.07 ng/mL and 27.48 ng/mL, respectively. Drug entrapment of prepared lipid nanoformulation was found to be 73.44 � 6.65%. The results conclude that the developed analytical method is simple, precise, sensitive, fast and reproducible. Applications of developed method for determination of drug entrapment in prepared lipid nanoformulation confirmed that the developed analytical method is suitable for estimation of lamotrigine in lipid nanoformulations.