American Journal of PharmTech Research

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.

Apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor, is widely used in the treatment of inflammatory diseases such as psoriasis and psoriasis arthritis. However, its poor water solubility to formulate and evaluate a Nanoemulsion (NE) system for Apremilast to enhance its solubility, stability, and bioavailability. A Nanoemulsion was developed using a high energy emulsification method, with a combination of oil, surfactant, and co-surfactant carefully selected based on solubility studies and construction of pseudo-ternary phase diagrams. Various formulations were prepared and evaluated for droplet size, polydispersity index (PDI), zeta potential, and drug encapsulation efficiency. The optimized formulation exhibited a droplet size of below 600 nm, a low PDI, and a stable zeta potential, confirming its stability. According to this report, the Nanoemulsion based delivery system for Apremilast drug could offer significant clinical advantages, particularly in terms of improved pharmacokinetics and enhanced therapeutics outcomes, paving the way for more effective treatment of inflammatory diseases such as psoriasis and psoriatic arthritis. Further in vivo studies are recommended to confirm the observed benefits and to evaluate long term safety and efficacy.