A promising controlled drug delivery system has been developed based on polymeric buccoadhesive bilayered formulation that uses a drug-free backing layer and a polymeric hydrophilic gel buccoadhesive core layer containing nifedipine. The DSC thermogravimetric analysis confirms the drug’s entrapment in the gel layer and reveals no evidence of a potential interaction. Various ratios of bioadhesive polymers, including HPMC K100, PVP K30, SCMC, and CP 934, were combined with EC as an impermeable backing layer to ensure unidirectional drug release towards the buccal mucosa. The polymeric compositions of hydrophilic gel-natured HPMC, SCMC, and CP formed a matrix layer by surrounding the core nifedipine during compression. Preformulation studies were performed for all of the ingredients in order to evaluate their physical and flow characteristics. Ex vivo buccoadhesive strength, surface pH, swelling index, in vitro and in vivo drug release, and ex vivo permeation investigations were performed to evaluate the produced gel-based system. Rapid temperature variations had no appreciable impact on the substance’s physical properties, pharmacological content, or buccoadhesive strength during stability testing using actual human saliva. It was clear from a histological examination of the ex vivo mucosa that the developed system did not cause any irritation or inflammation at the site of administration. The formulation NT5 was the best one, with a correlation coefficient of 0.9966. The in vitro and in vivo drug release profiles were well correlated, and they mimic the in vitro drug release pattern via the biological membrane. Thus, the developed gel-based formulation was found to be novel, stable, and useful for the targeted delivery of nifedipine.

An isocratic reversed phase high-performance liquid chromatographic method with ultraviolet detection at 220 nm has been developed for the quantification of itopride hydrochloride in tablet dosage form. The quantification was carried out using C(8) column (250 mm × 4.6 mm), 5-μm particle size SS column. The mobile phase comprised of two solvents (Solvent A: buffer 1.4 mL ortho-phosphoric acid adjusted to pH 3.0 with triethyl amine and Solvent B: acetonitrile). The ratio of Solvent A: Solvent B was 75:25 v/v. The flow rate was 1.0 mL (-1)with UV detection at 220 nm. The method has been validated and proved to be robust. The calibration curve was linear in the concentration range of 80-120% with coefficient of correlation 0.9995. The percentage recovery for itopride HCl was 100.01%. The proposed method was validated for its selectivity, linearity, accuracy, and precision. The method was found to be suitable for the quality control of itopride HCl in tablet dosage formulation.

The present investigation highlights the novel trans-buccoadhesive films of Famotidine, an H2 receptor antagonist used as an anti-ulcerative agent. The buccal films were fabricated by solvent casting technique with different polymer combinations of hydroxypropyl methylcellulose, carbopol-934P and polyvinyl pyrrolidone. Drug-polymer interaction studies by Fourier transform infrared spectroscopy show that there is no significant interaction between drug and polymers. The fabricated films were evaluated for their physicochemical characters like weight, thickness, surface pH, percentage moisture absorption, percentage moisture loss, swelling percentage, folding endurance, water vapor transmission and drug content. Stability study of buccal films was performed in natural human saliva. Ex vivo permeation studies were conducted using fresh sheep buccal mucosa and buccoadhesive strength was calculated by modified balance method and showed sufficient strength in all the formulations. Good correlation was observed between the in vitro drug release and in vivo drug release, with a correlation coefficient of 0.995. Drug diffusion from buccal films showed apparently zero order kinetics and release mechanism was diffusion controlled after considerable swelling.

The arrival of comprehensive genome sequencing has accelerated the understanding of genetically aberrant advanced cancers and target identification for possible cancer treatment. Fibroblast growth factor receptor (FGFR) gene alterations are frequent findings in various rare and advanced cancers refractive to mainstay chemo-therapy or surgical interventions. Several FGFR inhibitors have been developed for addressing these genetically altered FGFR-harboring malignancies, and some have performed well in clinical trials. In contrast, others are still being investigated in different phases of clinical trials. FDA has approved four anticancer agents such as erdafitinib, pemigatinib, infigratinib, and futibatinib, for clinical use in oncogenic FGFR-driven malignancies. These include cholangiocarcinoma, urothelial carcinoma, and myeloid/lymphoid malignancies. Pemigatinib is the only FGFR inhibitor globally approved (USA, EU, and Japan) and available as a targeted therapy for two types of cancer, including FGFR2 fusion or other rearrangements harboring cholangiocarcinoma and relapsed/refractory myeloid/lymphoid neoplasms with FGFR1 rearrangements. Myeloid/lymphoid neoplasm is the latest area of application added to the therapeutic armamentarium of FGFR inhibitors. Furthermore, futibatinib is the first-in-class covalent or irreversible pan-FGFR inhibitor that has received FDA approval for locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene aberrations. This review highlights the current clinical progress concerning the safety and efficacy of all the approved FGFR-TKIs (tyrosine kinase inhibitors) and their ongoing investigations in clinical trials for other oncogenic FGFR-driven malignancies.

The present investigation highlights the novel trans-buccoadhesive tablets of Famotidine, an H2-receptor antagonist used as an antiulcerative agent. The buccoadhesive tablets were prepared by direct compression method using bioadhesive polymers like sodium alginate, SCMC, HPMC-K100M, PVP-K30 either alone or in combinations with EC as a backing layer. The prepared formulations were evaluated for their physicochemical characteristics, swelling index, surface pH, ex vivo buccoadhesive strength, in vitro, in vivo drug release and ex vivo permeation studies. The distinguishable differences in the results were shown to be dependent on characteristics and composition of bioadhesive materials used. Stability studies were performed in natural human saliva and accelerated conditions showed no significant difference in physical appearance, drug content, buccoadhesive strength and the P-value statistically significant at <0.05. Ex vivo mucous irritation by histological examination reveals, the administration site of buccal tablet over the buccal mucosa did not cause any irritation, ulceration, inflammation and redness, and it resembles to controlled buccal mucosa. Good correlations were observed between in vitro and in vivo drug release, with a correlation coefficient of 0.996. Drug diffusion from buccal tablets showed apparently zero order kinetics and release mechanism was diffusion controlled after considerable swelling.

Objective: An anti-inflammatory analgesic called Fenoprofen Calcium Dihydrate (FCD) is used to treat mild to moderate pain as well as the symptoms of osteoarthritis and rheumatoid arthritis. The goal of the current study was to formulate, optimize, and assess FCD Mouth Dissolving Tablets (MDT). Methods: The sublimation process was used to create the MDT of FCD using a variety of superdisintegrants, including as Indian-414, Croscarmellose Sodium (CCS), and Sodium Starch Glycolate (SSG). Skimmed milk powder serves as an excipient, solubility enhancer, and taste-masking ingredient. One subliming substance used in the sublimation process is camphor. The design can be generated with three center points per block with 15 runs. The formulas were optimized using the Box-Bhenken Design (BBD) with three independent variables (X1, X2, X3) at three levels (-1, 0,+1) with a minimum to maximum range. R1, R2, and R3, whose titles were wetting time, drug content, and disintegration time, respectively, were the response or dependent variables. Results: Fifteen MDTs of FCD formulations with independent and dependent variables are optimized using BBD. The smooth flow is demonstrated by the micrometric study. All compositions, including powder blends, have flow abilities that vary from good to exceptional, with values between 25.11 and 32.87. The hardness of the tablet ranged from 2.3±0.19 to 2.9±0.13 kg/cm2. The findings indicated that the wetting duration was between 32±1.38 and 39±1.72 sec, and the water absorption ratio ranged from 65±1.58 to 83±1.8%. All produced formulations had drug contents ranging from 94.5±0.74 to 99.69±0.59. The range of the disintegration time was 39±2.38 to 47±1.46 sec. The proportion of FCD from the formulations S3, S8, and S13 was 99.57, 99.64, and 99.98 after 90 min. At the p0.05 level, the formulations S3, S8, and S13 demonstrated good stability and statistical significance. Conclusion: Sublimation was used to successfully construct FCD MDTs using a range of superdisintegrants, and the outcomes were good in every way.