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Journal of Applied Pharmaceutical Research
Published by Creative Pharma Assent
ISSN : -     EISSN : 23480335     DOI : 10.18231
Core Subject : Health,
Medicine & Pharmacology
Journal of Applied Pharmaceutical Research (JOAPR) is an official publication of Creative Pharma Assent (CPA). It is an open access, peer review online international journal. JOAPR is primarily focused on multiple discipline of pharmaceutical sciences (Pharmaceutics, Pharmaceutical Technology, Biopharmaceutics, Cosmetic Technology, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy and Phytochemistry, Herbal drugs/ formulations, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest) which publish quarterly. JOAPR also includes evaluation of pharmaceutical excipients & their practical application to research & industry based efforts. The aim of the scientific journal, JOAPR is to present a wide area for the current researchers to share their noble works and ideas in terms of the research papers, review articles and short communications. JOAPR only publish the original research works with a definite innovation and novelty after thorough reviewing. The paper must have a suitable and proper scientific background.
Arjuna Subject : -
Articles 514 Documents
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Optimization and evaluation of sirolimus nanodispersion drug-layered prednisolone tablets for the management of thrombocytopenia Pradeep Jena; Achal Mishra; Madhuri Baghel; Mayank Garhewal; Shekhar Verma
Journal of Applied Pharmaceutical Research Vol. 14 No. 4 (2026)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v14i4.2307

Abstract

Background: Thrombocytopenia is a hematological disorder characterized by a reduced platelet count, increasing the risk of bleeding and impairing hemostasis. The present study aimed to develop and optimize a fixed-dose combination tablet comprising a sirolimus nanodispersion layered onto a prednisolone core tablet using a Box–Behnken experimental design as a potential therapeutic strategy for thrombocytopenia. Methodology: Sirolimus nanodispersion drug-layered tablets were prepared and optimized using a three-factor, three-level Box–Behnken design. The optimized formulation was evaluated for critical quality attributes, including hardness and friability, and subsequently experimentally validated. Therapeutic efficacy was investigated in cyclophosphamide-induced thrombocytopenic Wistar rats by assessing platelet count, bleeding time, clotting time, and hematological parameters, including red blood cell count, hemoglobin, and hematocrit. Results and Discussion: The optimized formulation exhibited acceptable mechanical properties, with hardness ranging from 5.3 to 5.5 kg/cm² and friability below 1%, confirming the robustness of the optimization process. In vivo evaluation demonstrated a marked improvement in platelet recovery following treatment. The platelet count increased from 39.87 ± 8.82 × 10³/mm³ in the disease control group to 132.62 ± 21.76 × 10³/mm³ and 154.57 ± 7.40 × 10³/mm³ after once-daily and twice-daily administration, respectively. Furthermore, treatment significantly improved bleeding time, clotting time, and hematological parameters, indicating enhanced therapeutic efficacy. Conclusion: The optimized sirolimus nanodispersion drug-layered prednisolone tablet demonstrated favorable pharmaceutical characteristics and significant therapeutic efficacy in the cyclophosphamide-induced thrombocytopenia model. The developed fixed-dose combination represents a promising formulation strategy for improving the management of thrombocytopenia and warrants further preclinical and clinical investigation.
Creation and verification of an RP-UHPLC technique for abemaciclib and associated impurities in formulations and APIs using Box-Behnken design Kalpana Krishnaraju; Malarkodi Velraj
Journal of Applied Pharmaceutical Research Vol. 14 No. 4 (2026)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v14i4.2330

Abstract

Background: Strict impurity profiling is necessary to ensure the safety, effectiveness, and regulatory compliance of Abemaciclib (AbB), a selective CDK4/6 inhibitor frequently used in breast cancer treatment. However, a lack of thorough impurity separation, lengthy run times, and low sensitivity are common problems with current analytical techniques. Methodology: A novel reverse-phase ultra-high-performance liquid chromatography (RP-UHPLC) method was developed using a Quality by Design (QbD) framework. Critical method parameters, including mobile phase pH, flow rate, and column temperature, were optimized using Box-Behnken Design (BBD). Chromatographic separation was achieved on a C18 column using an isocratic mobile phase consisting of acetonitrile (40:60, v/v) and ammonium formate buffer (pH 2.7). The technique was validated in accordance with the ICH Q2(R1) requirements. Results and Discussion: The optimized method demonstrated exceptional linearity over the range of 0.02–150 μg/mL (R² > 0.999) with excellent precision (RSD < 2% for AbB and < 10% for related impurities) and showed acceptable accuracy, with mean recoveries ranging from 92.76% to 102.88% across AbB and its related impurities. The detection and quantification limits for AbB were 0.01 μg/mL and 0.02 μg/mL, respectively. Forced degradation studies that effectively distinguished degradation products in oxidative, acidic, and alkaline settings confirmed the method's stability-indicating nature. The 8-minute run time allowed for quick examination. The integration of BBD-based QbD significantly enhanced method robustness, resolution, and sensitivity compared to conventional chromatographic approaches, allowing simultaneous quantification of AbB and its related impurities. Conclusion: For routine quality control, stability investigations, and regulatory-compliant impurity profiling of Abemaciclib, the developed RP-UHPLC method is quick, sensitive, reliable, and appropriate.
Novel chemometric-driven greenness assessed spectroscopical method development and forced degradation study of sitagliptin phosphate in its bulk drug and ophthalmic formulation Debashis Mishra; Himansu Bhusan Samal; Diptimayee Jena; Kirtimaya Mishra
Journal of Applied Pharmaceutical Research Vol. 14 No. 4 (2026)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v14i4.2331

Abstract

Background: Sitagliptin phosphate (SIT), an antidiabetic drug, requires reliable analytical methods for routine quality control and stability assessment. UV-visible spectrophotometry offers a simple and economical approach; however, method robustness and stability-indicating capability must be ensured using systematic development strategies such as Quality by Design (QbD). The objective of this work is to develop and validate a rapid, simple, economical, accurate, and precise UV-visible spectrophotometric method with a stability-indicating capability for the analysis of SIT in bulk drug and ophthalmic formulation. Methodology: Method development was performed using a QbD approach in a quality control laboratory with a UV-visible spectrophotometer and 1 cm quartz cells. Various solvents (phosphate buffer, ethanol, acetonitrile, methanol, and water) were evaluated, with water selected due to superior solubility and spectral characteristics. SIT showed maximum absorbance at 265-267 nm. Forced degradation studies (acidic, basic, oxidative, thermal, and photolytic) were conducted. Validation was performed as per ICH Q2 (R1) guidelines. Results and Discussion: The developed method exhibited excellent linearity (R² ≥ 0.998), accuracy (99-101% recovery), and precision (%RSD ≤ 2%). Recovery ranged from 98.68% to 99.46%. The method was robust and successfully indicated stability under stress conditions. The application of QbD ensured systematic optimization and robustness. Water proved to be an ideal solvent, enhancing method simplicity and cost-effectiveness. The method effectively distinguished SIT from degradation products, confirming its stability-indicating nature. Conclusion: A validated, reliable, and economical UV-visible spectrophotometric method was successfully developed for SIT analysis, suitable for routine quality control and stability studies in bulk drug and ophthalmic formulations.
Solid self-microemulsifying drug delivery systems in modern pharmaceutics: design, characterization, and clinical applications P. R. Kaple; S. S. Agarwal
Journal of Applied Pharmaceutical Research Vol. 14 No. 4 (2026)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v14i4.2413

Abstract

Background: Approximately 40% of marketed medicines and 70% of pipeline products exhibit poor aqueous solubility, leading to inconsistent oral bioavailability and impaired efficacy. S-SMEDDS represent a revolutionary approach for converting liquids into stable solid dosage forms. Methodology: Methods employed to prepare S-SMEDDs include adsorption onto carriers, spray drying, hot-melt extrusion, and freeze-drying. Characterization includes assessing self-emulsifying behavior, dynamic light scattering, powder diffraction, and thermal analysis. Results and Discussion: Depending on the drug's characteristics, the formulation composition, and the study conditions, S-SMEDDS can increase bioavailability by two to ten times. However, for some extremely lipophilic BCS Class II and IV pharmaceuticals, significantly greater benefits (up to ~50-fold) have been documented. Several investigations have demonstrated that S-SMEDDS exhibit better physical and chemical stability than liquid systems under ICH Q1A(R2) accelerated storage conditions due to reduced lipid mobility and a lower risk of phase separation. Applications extend to the treatment of cardiovascular, oncological, and endocrine disorders with improved pharmacodynamic efficacy. The multiple absorption mechanisms in S-SMEDDS include improved solubilization, reduced precipitation, lymphotropic delivery, and inhibition of efflux pumps. They demonstrate higher chemical and physical stability, precise dosing, and better patient adherence when compared to traditional liquid counterparts. Conclusion: S-SMEDDS constitute an established pharmaceutical platform that overcomes the drawbacks associated with liquid lipid drug delivery systems. Their high effectiveness, manufacturability, and compatibility with novel technologies such as three-dimensional printing and artificial intelligence position them to be the foundation for precision oral drug delivery.

Page 52 of 52 | Total Record : 514

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