ABSTRACT

The eye is one of the most delicate organs in our body. The eye is a complex organ characterized by its low permeability, short precorneal residence time, and small area for absorption, which pose significant barriers to drug delivery. Typically, less than 10% of a drug administered penetrates the eye. Traditional ocular delivery systems are also constrained, with significant drug loss due to tears and blinking, leading to blurred vision and untimed release events without sustained action, resulting in suboptimal outcomes in ocular therapy. To overcome such challenges, in situ ophthalmic gels have been developed. These gels' ability to transition from a liquid to a gel state allows for sustained drug release at the target site. In situ gel systems are in solution form before administration and then convert to a gel under physiological conditions (pH, temperature, or ionic concentration). This review discusses the anatomy and physiology of the eye, the challenges of ocular drug delivery, types of in situ gelling systems, mechanisms of gel formation, types of smart polymers, and methods for evaluating polymeric in situ gels.   

Keywords: Ocular drug delivery, in situ gel, sol-gel transition, smart polymers, sustained release.

ABSTRACT

This study reports the method development and validation for anti-diabetic drugs by UPLC.  A new, simple, rapid, selective, precise and accurate ultra performance liquid chromatography assay has been developed for simultaneous estimation of Remogliflozin, Vildagliptin and Metformin. The separation was achieved by using ODS 3V column with dimensions 5 µm, 4.6 mm x 250 mm. The pH of mobile phase was adjusted to 4.5 with acetonitrile. The flow rate was 0.4 mL/min, and the separated drugs were detected using UPLC detector at the wavelength of 260 nm. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent. It was successfully applied for the analysis of these drugs in marketed formulations and could be effectively used for the routine analysis of formulations.

Keywords: Remogliflozin, Vildagliptin, Metformin, ICH guidelines

ABSTRACT

A rapid stability-indicating RP-HPLC was developed and validated for the estimation of Mirabegron and Solifenacin combination in bulk and tablet dosage form using Thermo C18 column (250 x 4.6 mm, 5m) as a stationary phase and a mixture solution of 0.1 percent Diazanium sulphate buffer: Acetonitrile (60:40 v/v) as the mobile phase at a flow rate of 1 ml/min. A photodiode array detector was used for detection at 246 nm. The linearity, sensitivity, selectivity, robustness, specificity, precision, and accuracy were all determined. The peak area response-concentration curve was rectilinear over the concentration ranges of 25-75 g/ml (Mirabegron) and 2.5-7.5 g/ml (Solifenacin), with quantitation limits of 0.793 g/ml (Mirabegron) and 0.307 g/ml (Solifenacin). The proposed method was validated for the simultaneous determination of mifepristone and misoprostol in combined tablet dosage form. In comparison to previously reported RP-HPLC methods, the performance of the proposed method was found to be rapid and cost-effective. The developed and validated stability-indicating RP-HPLC method was suitable for quality control and drug analysis.

Keywords: RP-HPLC, stability-indicating, tablet dosage form.

ABSTRACT

The goal of the current work is to use the wet granulation technology to make medication tablets using fenugreek extract. Additionally, research was done on the impact of sodium starch glycolate, a super disintegrant, on drug release and disintegration. Mucilage found in fenugreek extract slows down the disintegration of tablets, resulting in a slower release of the medication. Therefore, sodium starch glycolate was employed as a super disintegrant to enhance disintegration and, consequently, in vitro drug release. Wet granulation was used to make tablet formulations both with and without sodium starch glycolate. It was done to evaluate the granules' flow characteristics and characterize the physicochemical makeup of tablet formulations. The fundamental cause of fenugreek's antidiabetic effect is the alkaloid trigonelline, which is present in large amounts. For the treatment of diabetes, this study concludes that fenugreek seed extracts in tablet form with super disintegrants will be more desirable, useful, and therapeutically more effective than combining the plant components directly for a quicker commencement of action.

Keywords: Tablet; sodium starch glycolate; fenugreek.

ABSTRACT

Paleolithic diet also known as stone-age diet, is based on those food items that were available during the Paleolithic period, which dated from 2.5 million years ago to 10,000 B.C. This diet includes food items such as meat, fish, fruits, vegetables along with a very small number of cereals, roots, eggs, nuts, and excludes items like dairy products, grains, sugar, legumes, processed or refined oils, salt, coffee or tea, and alcohol. On one hand, the Paleolithic diet is beneficial in the case of chronic conditions like type 2 DM, cardiovascular diseases, obesity, and other such conditions. On the other hand, adherence to the Paleolithic diet leads to a few adverse effects like calcium deficiency, iodine, vitamin D, and more due to exclusion criteria of some food. Furthermore, evidence of clinical trials on a large population are needed as several trials conducted on a small sample will only lead to poor results resulting in lack of evidence. On a separate note, alternative diets are also opted for compensate the lack of elements to avoid any further medical consequences. Upcoming studies should throw light on clinically analyzing the health quality of excluding certain food items in the context of Paleolithic nutrition.

Keywords: Paleolithic Diet, Benefits, Drawbacks, Clinical trials, chronic conditions, Alternative diets.

ABSTRACT

21 CFR is the code of federal Regulation. It is the regulation which gives by the USA/America for the pharma Industries. It is started in 1935 by the America’s 32nd President (Franklil. D. Roosevlt). It is very useful for pharma Industries in future for the Manufacturing processing packaging or holding of drug and finish pharmaceutical’s. It is the regulation for the food and drugs. This paper explores Title 21 of the Code of Federal Regulations (21 CFR), highlighting its essential role in regulating various aspects of the pharmaceutical industry in the United States. It emphasizes 21 CFR's impact on ensuring the safety, efficacy, and quality of pharmaceuticals and biologics. The paper also examines its relevance in modern regulatory practices and its global influence on regulatory compliance and good manufacturing practices (GMP).It will most useful guidelines for new Pharmacists. It is the future of the pharma Industries. Which is trying to get approval from USFDA?

Keyword: 21 CFR, Manufacturing, Processing, Packaging, USFDA

ABSTRACT

A robust RP-HPLC technique was set up for the estimation of Abiraterone & Niraparib. SST parameters, including resolution, theoretical plates, & tailing factor, were within acceptable boundaries, ensuring the technique's reliability. technique verification followed ICH rules, demonstrating high assay accuracy with recoveries within 98-102%. The linearity scale was 10-50 µg per ml for Abiraterone & 2-10 µg per ml for Niraparib, with R² of 0.999. Precision, ID precision, & robustness tests confirmed the technique's consistency across different conditions. LOD & LOQ were established, showcasing the technique's sensitivity. This verified RP-HPLC technique is suitable for regular analysis of Abiraterone & Niraparib in l formulations.

Keywords: Niraparib, Abiraterone, QbD, RP HPLC. 

ABSTRACT

Reserve samples in the pharmaceutical industry are vital for quality assurance and regulatory compliance. Retained from each production batch, these samples ensure product quality, safety, and efficacy throughout their shelf life. They play a crucial role in investigating complaints, verifying product consistency, addressing regulatory inspections, and supporting stability studies. Regulatory bodies like the FDA, EMA, and WHO require strict guidelines for their handling, storage, and retention. Reserve samples must align with the product’s labeled storage conditions and be kept for at least one year beyond the expiration date or two years after the last distribution, whichever is longer. Sufficient quantities must also be maintained to allow at least two full quality analyses. Managing reserve samples involves challenges such as storage space limitations, environmental control costs, risk of degradation, and the need for precise documentation. However, technological advancements like automated inventory systems, IoT-based monitoring, and digital record-keeping have improved efficiency and reliability. These innovations reduce risks of non-compliance and enhance traceability. This review highlights the purpose, regulatory requirements, best practices, and challenges associated with reserve samples, as well as recent technological advancements. Reserve samples are integral to pharmaceutical operations, helping companies maintain product quality standards, consumer trust, and regulatory compliance. Continuous improvement in reserve sample management is essential to meet the evolving demands of the pharmaceutical industry.

Keywords: Reserve Samples, Pharmaceutical Quality, Regulatory Compliance, Stability Studies, Sample Management