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All Journal Journal of Applied Pharmaceutical Research IJRETINA - International Journal of Retina
Sharma, Vijay
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Health Professions Medicine & Pharmacology Public Health

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Journal : Journal of Applied Pharmaceutical Research

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QbD enabled optimization study of the variable concentration of phospholipid and stabilizer in the development of liposomal pastilles of solid dispersion polymeric composite of antihypertensive drug Aggarwal, Deepti; Gupta, Ram Dayal; Sharma, Vijay
Journal of Applied Pharmaceutical Research Vol. 13 No. 3 (2025)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v13i3.995

Abstract

Background: The study aimed to develop and optimize liposomes of the antihypertensive drug Felodipine (FH) using the Quality by Design (QbD) approach with a 3² Central Composite Design (CCD) in Design Expert software, followed by the development of pastilles. Methodology: Liposomes were prepared using the solvent injection method, with soya lecithin and cholesterol as key excipients, and a solid dispersion of FH. The impact of their concentrations on particle size (PS), drug content (DC), entrapment efficiency (EE), and in vitro and ex vivo drug release was analyzed using response surface methodology. The optimized formulation was validated using four batches (optimized batch, VC1, VC2, and VC3), ensuring a minimal percentage error. The liposomal formulation was incorporated into pastilles to enhance patient compliance, and these were evaluated for drug content, dissolution, bioadhesion, and stability. Results and Discussion: The optimized liposomes exhibited desirable properties, including a positive surface charge (PS, 1.41±0.12), a high DC (94.323±1.03), a high EE (69.61±1.13), in vitro drug release (70.73±1.08), and ex vivo drug release (66.88±0.23). The validation batches showed minimal percentage error, confirming the optimization process. The pastilles demonstrated excellent physical stability and bioadhesion, indicating their potential for improved patient compliance. Conclusion: The study showed the effectiveness of the QbD approach in optimizing a liposomal drug delivery system for FH, thereby minimizing the need for extensive trials. The incorporation of liposomes into pastilles provided a patient-friendly dosage form with enhanced bioadhesion and stability, making it a promising alternative for antihypertensive drug delivery.
Chitosan-based in-situ forming polyelectrolyte complexes for ciprofloxacin sustained release tablets Malik, Ajay; Verma, Navneet; Sharma, Vijay
Journal of Applied Pharmaceutical Research Vol. 13 No. 3 (2025)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v13i3.1034

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Background: It is not straightforward to create sustained-release (single-unit) oral dosage forms for hydrophilic medicines, which are highly soluble (10 mg/mL) in gastric fluids and have a high dose. This study is an attempt to utilize biopolymer Chitosan-based Polyelectrolyte complex as a retardant to develop and evaluate the sustained release tablet formulations (oral) of Ciprofloxacin hydrochloride. Methodology: Sustained-release tablets were prepared using the traditional wet granulation method, employing a neutralized chitosan solution (1% w/w) at 4°C in 1% acetic acid as the binder. Formulated tablets were assessed for pharmacopoeial and non-pharmacopoeial parameters, as well as in vitro 12-hour drug release studies. The different mathematical models were utilized to examine the pharmacokinetic parameters and elucidate the mechanism of drug release. Results and discussion: The sustained release of the drug for 12 hrs was confirmed through the in vitro release studies. Both formulations, CFX 2 and CFX 3 exhibited 97% and 98% cumulative drug release, respectively, after 12 hr. The dissolution profiles of both formulations were shown to be unaffected by the change in anionic polymers from one to two, as confirmed by dissolution profile comparison studies, with values of similarity factor (f2) 84 and of difference factor (f1) 2. The XRD studies confirmed the in situ formation of a polyelectrolyte complex between chitosan and anionic polymer, as evidenced by the presence of additional peaks in the diffractograms. Conclusion: The polyelectrolyte complexes not only provide a sustained drug release but also prevent the initial burst release of the the drug.
Co-Authors Aggarwal, Deepti Gupta, Ram Dayal Malik, Ajay Patyal, Sagarika Singh, Anuradha Trehan, Hemant Singh Vasudev, Vivek Verma, Navneet