Dr. P. Ashok Kumar

Melasma is a common acquired hyperpigmentation disorder characterized by the development of irregular, symmetrical, and brownish facial patches, which can significantly affect the appearance and quality of life of affected individuals. Methimazole, an antithyroid drug, has been investigated for its potential topical depigmenting activity due to its ability to interfere with melanogenesis. The present study was undertaken to develop and evaluate a methimazole-loaded emulgel intended for topical application in the management of melasma. Pre-formulation studies were carried out to determine the solubility, melting point, ultraviolet absorption maximum, and drug–excipient compatibility. The prepared formulations were evaluated for their physical appearance, homogeneity, pH, viscosity, spreadability, drug content, and in-vitro drug release characteristics. Drug–excipient compatibility was assessed using Fourier-transform infrared spectroscopy, while differential scanning calorimetry was employed to investigate the thermal characteristics of the formulation. The developed emulgels exhibited satisfactory physical characteristics with acceptable pH, viscosity, spreadability, and drug content, indicating their suitability for topical administration. In-vitro drug release studies demonstrated sustained release of methimazole from the emulgel formulations over the studied period. The release data were further analysed to understand the mechanism of drug release. Short-term stability studies were also performed to assess the physical and chemical stability of the prepared formulations. Overall, the study demonstrated the successful development of a methimazole-loaded emulgel with desirable physicochemical properties and controlled drug-release characteristics, suggesting its potential as a topical formulation for further investigation in the management of melasma. Emulgel have several merits like greaseless, easily spreadable, easily removable, emollient and transparency.

Dapsone is a synthetic sulfone with antimicrobial and anti-inflammatory activity, but conventional topical formulations may provide limited skin penetration and short local retention. This study aimed to develop, optimize, and characterize a dapsone-loaded solid lipid nanoparticle (DDP-SLN) polymeric hydrogel for controlled dermal delivery. DDP-SLNs were prepared by hot homogenization followed by probe ultrasonication using glyceryl monostearate (GMS), soya lecithin, and Tween 80. A three-factor, three-level Box–Behnken design using Design-Expert® Version 13 was employed to optimize the formulation based on particle size, entrapment efficiency, and 12-h cumulative drug release. The optimized DDP-SLN dispersion was incorporated into Carbopol 934 hydrogel and evaluated for physicochemical, rheological, drug-release, and stability characteristics. The optimized DDP-SLN showed a particle size of 140.38 nm, PDI of 0.287, zeta potential of −35.0 mV, and entrapment efficiency of 87.93%. The hydrogel exhibited homogeneous texture, pH of 6.23 ± 0.08, viscosity of 8486.67 ± 70.95 cP, and spreadability of 18.42 g·cm/s. Cumulative drug release reached 87.90% over 12 h and followed the Higuchi model (R² = 0.9910), while the Korsmeyer–Peppas exponent (n = 0.612) indicated anomalous transport. The formulation remained stable under the evaluated storage conditions, demonstrating its potential as a topical delivery system for dapsone. The system was designed to enhance drug localization while providing sustained release and hydrogel performance. These findings demonstrate the suitability of combining SLN technology with a hydrogel to improve topical dapsone delivery and maintain formulation quality.

ABSTRACT: mRNA based therapeutics have evolved emerged as a promising platform in modern medicine because they facilitate provisional production of specific protein within cells. Their applications extend beyond infectious disease vaccines to cancer immunotherapy, protein replacement, gene editing, regenerative medicine, and treating of genetic disorders. Although, the successful development of these products depends on appropriate control of RNA quality, stability, delivery system, manufacturing processes, safety, and efficacy. This research focus on reviewing the regulatory requirements for m RNA based therapeutics in India and Switzerland with particularly focus on the central drug standard control organization (CDSCO) and SWISSMEDIC. The study compares their regulatory framework, approval pathways, manufacturing requirements, quality and storage condition, development criteria. India follow its existing drug and biological product regulatory framework, while Switzerland provide a structured approach for innovative and advanced therapeutics products. The comparative assessment indicates that India has considerable potential for cost effective manufacturing and expanding mRNA research, whereas Switzerland has a highly developed pharmaceutical and research environment. Continued improvement in regulatory guidance, manufacturing capability, product characterization, delivery technologies and safety monitoring may facilitate the wider development and adoption of mRNA-based therapeutics.