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Though access to surgical care for cleft lip/palate has expanded in low- and middle-income countries (LMICs), post-palatoplasty speech therapy is often lacking due to limited healthcare infrastructure and personnel. This mixed-methods study seeks to: 1) evaluate the impact of task-shifted speech therapy on a standardized speech score; 2) describe the experiences of families with post-operative cleft care and associated barriers; and 3) understand how to optimize cleft care by exploring the experiences of children who had nominal improvements after task-shifted speech therapy.A convergent parallel mixed-methods study was conducted in Nepal. Standardized speech scores were compared by a blinded speech-language pathologist before and after the speech intervention. Semi-structured interviews (SSIs) and focus groups with families evaluated cleft care experiences and barriers. Qualitative and quantitative data were merged and analyzed.Thirty-nine post-palatoplasty children with speech deficits (ages 3-18) underwent task-shifted speech therapy, and demonstrated significant improvements in composite speech scores targeted by exercises (p0.0001) and weakness (p=0.0002), with improvements in misarticulation (p=0.07) and glottal stop (p=0.05) that trended towards significance. Forty-seven SSIs demonstrated that the greatest barriers to follow-up were family responsibilities (62%), travel/distance (53%), and work (34%). In five focus groups, families expressed a desire to improve their child's speech and seek formal speech therapy. The speech intervention was found to be beneficial because of the compassionate staff, free lodging/food, and ability to socialize with other cleft patients and families. After merging quantitative and qualitative data, we noted that younger children between 3 and 5 years old and families who traveled greater distances for healthcare access benefited less from the speech therapy intervention.Task-shifted speech therapy has the potential to improve cleft lip/palate speech in LMICs. Multiple biosocial issues limit access to appropriate post-operative care.

The objective was to develop a stable, reproducible and patient non-infringing novel transdermal drug delivery system “ nano-carrier transdermal gel ” (NCTG) in combination of partial dose replacement of diclofenac diethylamine (DDEA) by curcumin (CRM). The drug content of gel was 99.30 and 97.57% for DDEA and CRM. Plasma samples were analyzed by liquid chromatography with triple-quadrupole tandem mass spectrometer (LC–MS/MS). Data were integrated with Analyst™ and analyzed by WinNonlin ; stability parameters were analyzed using Tukey–Kramer multiple comparison test. Its average skin irritation scored 0.49 concluded to be non-irritant, safe for human use and in vivo studies revealed significantly greater extent of absorption and highly significant inhibition (%) of carrageenan induced paw edema. The results also demonstrated that encapsulation of drugs in nano-carrier increases its biological activity due to superior skin penetration potential. Hence, a novel once day transdermal gel of nano-carrier (nano-transfersomes; deformable vesicular) is achieved, to increase systemic availability, subsequent reduction in dose and toxicity of DDEA was developed for the treatment of inflammation.

The aim of the study was to develop and optimize Piroxicam transdermal gel formulation using three-factor, three-level Box-Behnken design by deriving a second-order polynomial equation to construct contour plots for prediction of responses as three selected independent variables with ratio of carbopol 974 (X1), ratio of propylene glycol (PG) (X2) and ratio of ethanol (X3). The dependent variables studied were the skin permeation rate of piroxicam (Y1), viscosity of the gel (Y2) and pH of the gel (Y3). Response surface plots were drawn, statistical validity of the polynomials was established to find the compositions of optimized formulation which was evaluated using the vertical Franz-type diffusion cell. The permeation rate of piroxicam increased proportionally with ethanol concentration but decreased with polymer concentration. The design demonstrated the role of the derived polynomial equation and contour plots in predicting the values of dependent variables for the preparation and optimization of gel formulation.

The aim of this study was to develop and optimize a transdermal gel formulation for Diclofenac diethylamine (DDEA) and Curcumin (CRM). A 3-factor, 3-level Box-Behnken design was used to derive a second-order polynomial equation to construct contour plots for prediction of responses. Independent variables studied were the polymer concentration (X(1)), ethanol (X(2)) and propylene glycol (X(3)) and the levels of each factor were low, medium, and high. The dependent variables studied were the skin permeation rate of DDEA (Y(1)), skin permeation rate of CRM (Y(2)), and viscosity of the gels (Y(3)). Response surface plots were drawn, statistical validity of the polynomials was established to find the compositions of optimized formulation which was evaluated using the Franz-type diffusion cell. The permeation rate of DDEA increased proportionally with ethanol concentration but decreased with polymer concentration, whereas the permeation rate of CRM increased proportionally with polymer concentration. Gels showed a non-Fickian super case II (typical zero order) and non-Fickian diffusion release mechanism for DDEA and CRM, respectively. The design demonstrated the role of the derived polynomial equation and contour plots in predicting the values of dependent variables for the preparation and optimization of gel formulation for transdermal drug release.