Karnataka

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: Artificial Intelligence (AI) is emerging as a transformative technology in pharmaceutical regulatory affairs, enhancing efficiency, accuracy, and regulatory decision-making throughout the product lifecycle. Recent studies have demonstrated the application of AI and Machine Learning (ML) in regulatory intelligence, dossier preparation, document management, pharmacovigilance, signal detection, and compliance monitoring. Regulatory agencies worldwide are increasingly exploring AI-driven approaches to streamline regulatory submissions and improve review processes while maintaining safety, efficacy, and quality standards. This review aims to evaluate the role of AI in transforming regulatory affairs and to compare the adoption and implementation of AI-enabled regulatory practices by the Central Drugs Standard Control Organization (CDSCO), India, and Health Canada. The study examines current applications of AI in regulatory operations, including automated document review, adverse event monitoring, data analytics, and decision-support systems. Furthermore, it assesses the opportunities, challenges, and regulatory considerations associated with AI integration, such as data governance, transparency, validation, ethical concerns, and workforce readiness. The study concludes that AI has the potential to reshape the future of regulatory science by improving operational efficiency and regulatory effectiveness. Strategic adoption of AI technologies by regulatory authorities can contribute to faster access to safe and effective medicines while maintaining high regulatory standards4.

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.

Herbal antacid chewing gum is becoming popular as one of the simplest and most patient-compliant ways to treat acidity and related stomach issues. Safe and convenient therapy appears to be in demand given the prevalence of illnesses like GERD (gastroesophageal reflux disease), etc. The advantages of using natural herbal remedies in conjunction with chewing gum therapy seem to be a practical approach. Saliva secretion increases the gastric acid's buffering effect during chewing, ensuring a gradual release of the active substances. This review highlights few of the popular used herbal agent used as antacid and gastroprotective and explains the role of herbs in managing acidity. Different strategies for formulating are discussed along with significant materials and preparation techniques. Few significant parameters to be measured are discussed like acid neutralizing capacity, drug release, texture, stability. Available patents, future prospects are briefly discussed. In conclusion, it can be stated that chewing gums for antacids using herbal agents offer a good substitute. KEY WORDS: Herbal antacid chewing gum, gastroprotective activity, acid neutralization, herbal formulations, chewable dosage form.

Onychomycosis also referred to as dermatophytic onychomycosis or Tinea unguium, is a fungal nail infection primarily caused by dermatophytes (like Trichophyton rubrum), yeasts (like Candida albicans), and non-dermatophytic moulds. In this study, an effort was made to develop a herbal medicated antifungal nail lacquer using Caesalpinia bonducella seeds. The objective was to enhance clinical efficacy while improving patient compliance. Authenticated C. bonducella seeds were extracted and formulated into nail lacquers using suitable excipients, including film-forming agents, plasticizers, solvents, penetration enhancers, and resins. The prepared formulations were evaluated for various physicochemical and biological parameters such as smoothness, glossiness, non-volatile content, drug content, adhesion, diffusion, and antifungal activity (zone of inhibition). FTIR analysis confirmed drug–excipient compatibility by retaining characteristic peaks. Among the formulations, F5 was identified as the optimized batch and subjected to accelerated stability testing under ICH guidelines at 37 ± 2 °C for one month. The results showed no significant changes in its initial characteristics, while the formulation maintained excellent antifungal activity. Overall, the developed antifungal nail lacquer demonstrated safety, stability, and effectiveness, suggesting its potential as a novel dosage form for the treatment of dermatophytic nail infections such as onychomycosis. Its use may significantly improve therapeutic outcomes and patient adherence compared to conventional therapies.

Gastro retentive drug delivery system (GRDDS), these dosage forms are designed to achieve prolonged gastric residence time in controlled release manner. The floating drug delivery system (FDDS) also comes under the gastro retentive drug delivery system. These type of formulations helps to improve the solubility of poorly soluble drugs and enhances the bioavailability of the drug. In gastrointestinal tract the absorption of dosage form or drug molecule is a highly variable process. To overcome all these physiological problems Novel Drug Delivery System (NDDS) plays an important role. FDDS works on the principle of buoyancy (the tendency of an object or a molecule float in a fluid or the upward force that a fluid exerts on an object) which allows the drug to remain in the gastric environment for a prolonged period of time without rapid passing into the intestine. Floatation of a drug is due to bulk density less than gastric fluids and so, remain buoyant in the stomach for a prolonged period of time. Releasing the drug slowly at the desired rate and increase the bioavailability of narrow absorption window drugs. This review helps to know the floating drug delivery system principle, advantages and disadvantages, need for floating bilayer tablets, challenges in bi-layer tablet manufacturing and characterization and evaluation methods for bilayer floating tablets.

This study was designed to evaluate, learning and memory enhancing activity of aqueous and ethanolic extracts of whole plant of Sida veronicaefolia in rats using Elevated plus maze(EPM), Hebb William Maze(HWM), and Morris water maze(MWM) and to evaluate brain Acetylcholine esterase activity ,lipid peroxidation, superoxide dismutase activity, catalase and glutathione level. Rats were divided into 7 groups of 6 no each. Group 1(control) animals received vehicle , Group 2 animals received scopolamine (0.4mg/kg i.p.), on 19th and 27th day only, Groups 3 and 4 animals received 200mg/kg and 400mg/kg p.o. of aqueous extraction of Sida veronicaefolia. Group 5 and 6 animals received 200mg/kg and 400mg/kg p.o. of ethanolic extraction of Sida veronicaefolia and Group 7 animals received piracetam (400mg/kg i.p.) for 27 days, followed by scopolamine (0.4mg/kg i.p.) single dose on 19th and 27th day only. Assessment of transfer latency (TL), time taken to reach reward chamber (TRC) and assessment of swim latency (SL) was one on 19th and 27th day using elevated plus maze, Hebb William maze and Morris water maze. Animals were sacrificed on 27th day, brain acetylcholine esterase activity, lipid peroxidation, superoxide dismutase activity, catalase activity and glutathione level were estimated. The data was expressed as mean ± S.E.M. The statistical analysis was done by means of ANOVA followed by Dunnett’s post hock test. The aqueous and ethanolic extracts of Sida veronicaefolia decreased Tranfer Latency, Time taken to reach Reward Chamber and Sim Latency in comparison to scopolamine treated rats, decreased acetylcholine esterase activity and lipid peroxidation and increased super oxide dismutase, glutathione and catalase activity in brain.

Depressive Disorder medications are pharmacological agents that are used to treat Major Depressive Disorder disease. The intention of the present study is to design and characterization of fast dissolving buccal films of Paroxetin.  Films were prepared by using different polymers like HPMC E15, PVA, PVP and Glycerol as plasticizer and saccharin as a sweetening agent and vanillin as a flavoring agent. Buccal films were prepared using solvent casting technique. The major problem with Paroxetine was it belongs to class ? in BCS classification and have low solubility in biological fluids. In order to enhance the solubility of Paroxetine solid dispersion of Paroxetine   were prepared by melting technique at different drug carrier (PEG 4000) weight ratios and evaluated. No interaction was found between the drug and the polymers which was obtained by FTIR studies. The buccal films were evaluated for Folding endurance, weight variation, Drug content, Thickness, permeation study and in-vitro drug release study. Dissolution profile were studied by using USP dissolution apparatus type I, pH 6.8 simulated saliva were used as dissolution media. The influence of variable like polymer type, and their concentration, on Paroxetine release profile was studied. The formulation was optimized on the basis of various evaluation parameters like drug content and In-vitro drug release. Formulation F3 successfully gave the fast release of drug within 12 minutes. Stability studies were as per ICH guide lines and result indicated that the selected formulation was stable.

Surgery is the art of practice or work of treating diseases, injuries or deformities by manual or operative procedures. Before the start of operative procedures, a very brief course of antibiotics is initiated. This study aims to study the antibiotic utilization in surgical prophylaxis. This was a prospective and observational study conducted on 303 patients for a period of 06 months with the approval of institutional ethical committee from the Apollo multi specialty hospital & research center. Those who satisfied the study criteria were consented and participated for the study. Among 303 patients 183 male and 120 females were enrolled for the study. Most of the participants were in the age group of 31- 40 years. 205 patients had a clean- contaminated wound. Inj. Cefuroxime was the most prescribed prophylactic and post-surgical antibiotic in this study to avoid surgical site infection. None of the patients had developed any surgical site infections and the results which were satisfiable. Rational therapy with antibiotics helped patients to improve the quality of life by reducing financial and physical burden.