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Important elements of drug security and oversight include legal structures for monitoring and disclosing negative drug reactions and after-market surveillance of pharmaceutical goods. ADRs must be tracked and reported to regulatory authorities under these frameworks, which include laws, rules, and policies. This research provides some materials and methods which help to gather information related to this topic. Once they’ve been placed on the market, they also set up processes for ongoing drug surveillance in order to guarantee the continuous safety and effectiveness of pharmaceuticals. The result of this study gathers the information and discussion helps to identify the area of the study which is essential. Through the identification and mitigation of possible dangers related to pharmaceutical goods, the facilitation of prompt interventions and the promotion of openness and responsibility in the pharmaceutical business, these legal frameworks seek to safeguard public health. [ABSTRACT FROM AUTHOR]

Divalproex sodium is considered as the most important antiepileptic drug and widely used for treatment of epilepsy and bi-polar disorders and prophylaxis of migraine. The present work has been done to formulate sustained release tablet of Divalproex sodium. The FTIR study revealed that there was no interaction between drug and polymer and combination can be safely prepared. Tablets were prepared by wet granulation technique as poor flow property exhibited by pure drug. HPMC K4M and HPMC K100M polymer used to retard the drug release from sustained release in different proportion and combination and evaluated for physical parameter along with in vitro drug release studies. The optimized batch (F7), which extends the Divalproex sodium releasewithin18hrs was selected. In vitro drug release studies were performed using USP type II apparatus (paddle method) in 900 ml of phosphate buffer pH 6.8 at 100 rpm. Finally, tablets were prepared by wet granulation and punched. The tablets were evaluated for hardness, thickness, weight variation, friability, drug content uniformity and in vitro drug release. All the physical parameters were in acceptable limit of pharmacopeial specification. The stability studies, shown the tablet was stable at 400C/ 75% RH for a period of 2 months. [ABSTRACT FROM AUTHOR]

Aim of the present study was to develop and evaluate gastroretentive carbamazepine microspheres by solvent evaporation technique. From the preliminary study, the batch FMC2 was selected for factorial study. Factorial batches showed the mean particle size (FFMC1- FFMC9) in the range of 245.32±0.21 to 405.14±0.14μm. The percentage yields were found to be in the range from 72.09±0.21 to 96.83±0.23. The buoyancy percentage was calculated and found that all formulations were able to float on dissolution medium for 12 h. The swelling study was found to be 799.0±0.14 to 876.4±1.67. Batch FFMC2 showed better drug release i.e. 99.25%. The optimized formulation FFMC2 showed n value of 0.8601 and R2 value of 0.9984 respectively. The optimized formulation obeys Korsmeyer-Peppas release. SEM images of microspheres were spherical, discrete, and freely flowing. ANOVA for the formulations showed P-value less than 0.0500. The stability study indicated no significant change in the microspheres. In radiographic images floating microspheres were retained in stomach of rabbit for 12 hours. [ABSTRACT FROM AUTHOR]

The purpose of this work was to develop extended release (ER) matrix tablets of gabapentin, an anticonvulsant drug. The tablets were prepared by direct compression method along with hydrophilic matrix materials like HPMC K4M, HPMC K 15M and HPMC K 100M. The blends were evaluated for bulk density, angle of repose and compressibility index. The tablets subjected to thickness, diameter, weight variation test, drug content, hardness, friability, and in vitro release studies in 0.1N HC1 solution for the initial 2h, followed by pH 6.8 phosphate buffer solutions up to 12 hours. The drug release study revealed that matrix tablets containing HPMC K 15M and HPMC K 100M polymer exhibited more extended release than the tablets containing other polymers. Formulation F7 showed desired drug release up to 12 h. For the optimized formulation, kinetic modeling of in vitro dissolution profiles revealed the drug release mechanism ranges from diffusion controlled or Fickian transport to anomalous type or non-Fickian transport. Fitting the in vitro drug released data to Korsmeyer equation indicated that diffusion along with erosion could be the mechanism of drug release in optimized formulation F7. [ABSTRACT FROM AUTHOR]

AbstractErlotinib, a potent epidermal growth factor receptor (EGFR) inhibitor, faces bioavailability challenges due to poor water solubility and stability. This study aims to optimize erlotinib-loaded PLGA nanoparticles using a 32 factorial design to enhance drug delivery and therapeutic efficacy. The effects of PLGA concentration (R1) and NaTPP concentration (R2) on nanoparticle characteristics, including particle size, zeta potential, and polydispersity index (PDI), were investigated. The optimal formulation (F5) was identified and characterized, showing a particle size of 169.1 nm, a zeta potential of 20.0 mV, and a PDI of 0.146, indicating uniform and stable nanoparticles. Transmission electron microscopy (TEM) confirmed spherical nanoparticles with minimal aggregation, while X-ray diffraction (XRD) indicated an amorphous state of erlotinib. Formulation F5 demonstrated an entrapment efficiency of 81.9% and a yield of 83.0%. In-vitro drug release studies revealed a sustained release pattern with 90.0% cumulative release at 48 h, following Zero Order kinetics. Cytotoxicity assays showed low cytotoxicity across various cell lines. Statistical analysis confirmed the significant impact of formulation variables on nanoparticle properties. The systematic optimization of erlotinib-loaded nanoparticles has successfully identified formulation F5 as an optimal candidate with favorable characteristics, including minimal particle size, high stability, controlled drug release, and a safe cytotoxicity profile. Notably, the optimized formulation (F5) enhances therapeutic efficacy through improved bioavailability and targeted delivery, addressing the limitations of conventional therapies. These findings suggest that the optimized erlotinib-loaded nanoparticles hold significant potential for enhanced drug delivery and therapeutic efficacy. [ABSTRACT FROM AUTHOR]