1 Exemplify Biopharma Inc., Cranbury, New Jersey, USA – 08512.
2 Shree S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Ganpat Vidyanagar, Mehsana–4 Gozaria Highway, Kherva, Gujarat, 384012, Mehsana, India.
3 Hovione, East Windsor, New Jersey, USA-08520.
4 Hemchandracharya North Gujarat University, Patan, Gujarat, India-384265.
5 Exemplify Biopharma Inc., Cranbury, New Jersey, USA – 08512.
6 Lamar University, 4400 S M king Jr PKWY, Beaumont, Texas, USA-77705.
Research Article
World Journal of Advanced Research and Reviews, 2024, 22(02), 1006–1020
Received on 08 April 2024; revised on 14 May 2024; accepted on 16 May 2024
A novel Single Core Osmotic Pump (SCOP) pill has been created to administer high doses of the low solubility medication Rifaximin using osmosis. The formulations were evaluated using six comparative parameters: Q24 (total release after 24 hours), Q12 (total release after 12 hours), TL (lag time), RSQzero12 (R square of the zero-order equation for drug release in 12 hours), RR12 (in vitro release rate for 12 hours), and T80% (time required to deliver 80% of the drug). The drug release profile from osmotic devices shows that the choice of polymer and its concentration in the core formulation can significantly impact the release of the drug. Augmenting the osmogent quantity to an optimal level resulted in a substantial enhancement of Q12 and a notable improvement in the zero-order release pattern of rifaximin. In order to improve the bioavailability of the core formulation, an additive called citric acid was included. Citric acid has several properties that contribute to this enhancement, such as increased solubility of the active ingredient, the creation of a difference in osmotic pressure, regulation of the flow of the active ingredient, and making the composition containing the active ingredient more water-loving. Consequently, TL and T80% experienced a decline, whereas Q12 and RR12 saw a rise. The concentration of PEG 4000 in the semipermeable membrane of the SCOP was found to have a significant impact on TL, T80%, Q12, Q24, and RR12. Specifically, increasing the concentration of PEG 4000 led to a decrease in TL and T80%, while increasing Q12, Q24, and RR12. The optimal aperture diameter for achieving a zero-order release pattern was found to be 850 μm. This study also demonstrated that optimizing the thickness of SPM is crucial for achieving zero order kinetics. The invented SCOP technology has the potential to create a single layer osmotic controlled release tablet of a water insoluble medication with a high dosage.
Single Core Osmotic Pump; Water Swellable Polymer; Osmotic Agent; Rifaximin; Solubilizer; Coating and Drilling
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Pravinkumar Darji, Jayendrakumar Patel, Shalin Parikh, Binit Patel, Viratkumar Khatri, Praneeth Ivan Joel Fnu and Seshadri Nalla. Development of single layer osmotic controlled release tablet for low soluble drug: Single Core Osmotic Pump (SCOP). World Journal of Advanced Research and Reviews, 2024, 22(2), 1006-1020. Article DOI: https://doi.org/10.30574/wjarr.2024.22.2.1488