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Godge, Rahul
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Medicine & Pharmacology

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Stability indicating RP-HPLC method for estimation of cariprazine hydrochloride in human plasma Shelke, Mohini; Godge, Rahul; Sahane, Tejas; Pawar, Onkar; Kasar, Sujata
Journal of Applied Pharmaceutical Research Vol. 12 No. 2 (2024)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.18231/j.joapr.2024.12.2.27.34

Abstract

Objective: The objective of the study is to create and validate the easy, dependable, accurate, sensitive, and selective RP-HPLC method for estimating Cariprazine HCl in human plasma. Methodology: The sample was prepared using the protein precipitation extraction method. The chromatographic separation was performed with an AGILENT C18 column (250mm x 4.6ID) as the stationary phase and a mobile phase consisting of a 75:25 v/v solution of Methanol and 0.1% Orthophosphoric acid at a flow rate of 0.7 ml/min. The DAD detector was used to carry out the detection at 253 nm. Cariprazine HCl had a reduced retention duration of 2.46 minutes. Results & Discussion: The calibration curve had a correlation coefficient of 0.998 and was linear over the concentration range of 1–5µg/ml. The method's accuracy was shown at levels between 80%, 100%, and 120% of the specification limit. The developed method exhibited excellent precision, with interday precision ranging from 0.07% to 1.77% and intraday precision from 0.03% to 0.26%. It was discovered that the recovery of Cariprazine HCl was within the 98% range. Cariprazine HCl was discovered to have a Limit of Detection (LOD) of 0.053µg/ml, and the Limit of Quantification was found to be 0.160µg/ml. Conclusion: The solution was injected in duplicate, and the % RSD was measured. The results indicate that the proposed method can be effectively utilized for the routine analysis of Cariprazine HCl in human plasma. The forced degradation studies indicate that the drug is susceptible to Hydrolytic and Photolytic degradation
Development and validation of a QbD-based RP-HPLC method for vericiguat quantification Mandhare, Shubham; Godge, Rahul; Vikhe, Akshay; Talole, Shubham
Journal of Applied Pharmaceutical Research Vol. 12 No. 2 (2024)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.18231/j.joapr.2024.12.2.57.67

Abstract

Aim: An RP-HPLC method for Vericiguat using the QbD approach was developed and validated by ICH guidelines. Method: The ICH (Q2R1) guidelines have been followed in the development and validation of an RP-HPLC technique by considering several validation parameters like linearity, precision, LOD, LOQ, and accuracy. The study was performed on Agilent Tech using the C18 column (4.6x250 mm; 5 µm) and Chemstation 10.1 software with statistical data analysis, and the detector used was UV (DAD). Results: The mobile phase used for separation was Methanol: 0.1% OPA in the ratio of (76:24) at room temperature, the flow rate was 0.8ml/min, and the wavelength was 331nm. The results indicated that the quantification limit was 0.7209 µg/ml, and the detection limit was 0.2379 µg/ml. Conclusion: The validation studies confirmed that the developed method is fast, accurate, precise, cost-effective, selective, and useful for routine analysis of vericiguat in tablet dosage forms.
Design, development, and optimization of mucoadhesive buccal films of ganaxolone for enhanced bioavailability Pawar, Onkar; Godge, Rahul; Shinde, Ganesh; Barde, Kailas; Vikhe, Akshay
Journal of Applied Pharmaceutical Research Vol. 13 No. 2 (2025)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v13i2.943

Abstract

Background: CDD disorder affects children mainly during their first three months of life. The buccal route offers advantages over oral administration for ganaxolone by avoiding first-pass metabolism and providing direct systemic absorption. This study aimed to formulate and characterise mucoadhesive buccal films of ganaxolone to increase its bioavailability. Methods: Mucoadhesive buccal films were prepared using a solvent casting technique employing HPMC K4M and Moringa gum as polymers. The formulation was optimized using a 32-factorial design, where polymer concentrations were varied systematically to achieve optimal film properties. Nine batches (OF1-OF9) were formulated and evaluated for various physicochemical parameters, mucoadhesive strength, percentage drug content, goat buccal mucosa permeation study, and stability analysis. Results: Based on the findings, the OF8 batch containing optimal polymer ratio (250mg HPMC K4M and 60mg Moringa gum) emerged as the superior formulation with 94.45±0.34% drug content, 15.37±0.58 N/mm² tensile strength, and 7.8±0.57 N mucoadhesive strength. Permeation studies consequently confirmed 96.37% of the drug at 8 hours with a 13.63 µg /cm² /h permeation rate. There was no evidence of drug-excipient interaction in FTIR and DSC analysis. The formulation was set to be stable for 6 months at accelerated conditions (40±2°C, 75±5% RH) with an average tensile strength above 15 N/mm² and an average ex-vivo drug permeation of 93%. Conclusion: This optimized buccal film formulation demonstrates promising potential for clinical application in CDD treatment by offering enhanced bioavailability, controlled release, and patient-friendly administration, which is particularly beneficial for pediatric patients.
Formulation and optimization of upadacitinib-loaded transdermal patches for rheumatoid arthritis with zero-order release kinetics Talole, Shubham; Godge, Rahul; Tambe, Nikita; Mhase, Nikita
Journal of Applied Pharmaceutical Research Vol. 13 No. 2 (2025)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v13i2.1037

Abstract

Background: To develop and optimize Upadacitinib-loaded transdermal patches for rheumatoid arthritis treatment with improved patient compliance and sustained drug delivery. Methodology: Upadacitinib transdermal patches were formulated using a 3² factorial design approach with PVP K30 and HPMC K4M as key polymeric components. The patches were characterized for physicochemical, mechanical, and ex vivo permeation properties. Results and Discussion: The optimized formulation (SF8) exhibited excellent physicochemical characteristics, including high drug content (99.05 ± 0.83%), optimal mechanical properties with tensile strength of 0.912 kg/mm² and adhesion strength of 3.94 N. The ex vivo permeation reached 86.35% at 12h, with the flux of 102.91 μg/cm²/h following zero-order kinetics (R² = 0.9777). The experimental values closely matched predicted values with less than 2% error. Accelerated stability studies confirmed minimal changes in critical parameters over six months. Conclusion: The optimized Upadacitinib transdermal patch provides sustained drug delivery with zero-order release kinetics and excellent stability. This transdermal delivery system offers a promising alternative to oral therapy with potential advantages of improved patient compliance, reduced dosing frequency, and avoidance of first-pass metabolism for rheumatoid arthritis management
Formulation, optimization, and standardization of orodispersible herbal tablets using design of experiments (DOE) Shinde, Ganesh; Jadhav, Ravindra; Godge, Rahul; Vikhe, Dattaprasad; Tambe, Vishal; Khule, Shubham
Journal of Applied Pharmaceutical Research Vol. 13 No. 4 (2025)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v13i4.973

Abstract

Background: This study aimed to develop and optimize an orodispersible herbal tablet incorporating Achyranthes aspera Linn extract. Sodium Starch Glycolate and Crospovidone were employed as superdisintegrants to promote rapid tablet disintegration, while β-cyclodextrin was utilized to enhance the solubility of specific constituents within the extract. The optimized formulation exhibited a rapid disintegration time of 1.805 seconds and achieved a cumulative drug release of 98.04%, indicating improved dissolution and potential enhancement in oral bioavailability. Methodology: Orodispersible tablets were formulated using Design of Experiments (DOE) software, with crospovidone and sodium starch glycolate as independent variables, and time of disintegration and cumulative drug release as dependent variables. The formulation was evaluated for weight variation, uniformity, hardness, wetting time, and in vitro dispersion time. Result & Discussion: The optimized F6 batch of orodispersible herbal tablets demonstrated the following characteristics: hardness of 2.98 kg/cm², friability of 0.58%, weight variation of 3.319%, disintegration time of 13.805 seconds, wetting time of 34.4 seconds, content uniformity of 99.5%, water absorption of 36%, and cumulative drug release of 98.04%, all within the permissible limits as per official pharmacopoeialstandards. Conclusion: The study concludes that crospovidone and sodium starch glycolate effectively reduce disintegration time and improve cumulative drug release. These findings validate the reliability of the model, with minor deviations attributed to experimental variability.
Co-Authors Barde, Kailas Jadhav, Ravindra Kasar, Sujata Khule, Shubham Mandhare, Shubham Mhase, Nikita Pawar, Onkar Sahane, Tejas Shelke, Mohini Shinde, Ganesh Talole, Shubham Tambe, Nikita Tambe, Vishal Vikhe, Akshay Vikhe, Dattaprasad