Publications by authors named "Preethi Mandati"

3 Publications

  • Page 1 of 1

Fabrication of a shell-core fixed-dose combination tablet using fused deposition modeling 3D printing.

Eur J Pharm Biopharm 2022 Aug 11;177:211-223. Epub 2022 Jul 11.

Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA; Pii Center for Pharmaceutical Technology, The University of Mississippi, University, MS 38677, USA. Electronic address:

Fixed-dose combinations (FDCs) achieve optimal goals for treatment with minimal side effects, decreased administration of large number of tablets, thus, greater convenience, and improved patient compliance. However, conventional FDCs do not have a guaranteed place in the future of patient-centered drug development because of the difficulty in achieving dose titration of each drug for individualized specific health needs and desired therapeutic outcomes. In the current study, FDCs of two antihypertensive drugs were fabricated with two distinct compartments using fused deposition modeling three-dimensional printing (FDM-3DP). Atorvastatin calcium and Amlodipine besylate loaded filaments were prepared by hot-melt extrusion. Shell-core FDC tablets were designed to have different infills for individualized dosing. Differential scanning calorimetry and powder X-ray diffraction revealed that both drugs were transformed into amorphous forms within the polymeric carriers. The fabricated tablets met the United States Pharmacopeia acceptance criteria for friability, content uniformity, and dissolution testing. The fabricated tablets were stable at room temperature with respect to drug content and thermal behavior over six months. This dynamic dosage form provides flexibility in dose titration and maintains the advantages of FDCs, thus achieving optimal therapeutic outcomes in different healthcare facilities.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ejpb.2022.07.003DOI Listing
August 2022

A systematic and robust assessment of hot-melt extrusion-based amorphous solid dispersions: Theoretical prediction to practical implementation.

Int J Pharm 2022 Jun 23;624:121951. Epub 2022 Jun 23.

Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA; Pii Center for Pharmaceutical Technology, The University of Mississippi, University, MS 38677, USA. Electronic address:

Amorphous solid dispersions (ASDs) have gained attention as a formulation strategy in recent years, with the potential to improve the apparent solubility and, hence, the oral bioavailability of poorly soluble drugs. The process of formulating ASDs is commonly faced with challenges owing to the intrinsic physical and chemical instability of the initial amorphous form and the long-term physical stability of drug formulations. Numerous research publications on hot-melt extrusion (HME) technology have demonstrated that it is the most efficient approach for manufacturing reasonably stable ASDs. The HME technique has been established as a faster scale-up production strategy for formulation evaluation and has the potential to minimize the time to market. Thermodynamic evaluation and theoretical predictions of drug-polymer solubility and miscibility may assist to reduce the product development cost by HME. This review article highlights robust and established prediction theories and experimental approaches for the selection of polymeric carriers for the development of hot melt extrusion based stable amorphous solid dispersions (ASDs). In addition, this review makes a significant contribution to the literature as a pilot guide for ASD assessment, as well as to confirm the drug-polymer compatibility and physical stability of HME-based formulations.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ijpharm.2022.121951DOI Listing
June 2022

Pharmaceutical Co-Crystals, Salts, and Co-Amorphous Systems: A Novel Opportunity of Hot Melt Extrusion.

J Drug Deliv Sci Technol 2021 Feb 9;61. Epub 2020 Nov 9.

Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.

Enhancing the solubility of active drug ingredients is a major challenge faced by scientists and researchers. Different approaches have been explored for the enhancement of solubility and physicochemical properties of drugs, without affecting their stability or pharmacological activity. Among the various strategies available, pharmaceutical co-crystals, co-amorphous systems, and pharmaceutical salts as multicomponent systems (MCS) have gained interest to improve physicochemical properties of drugs. Development of MCS by conventional methods involves the utilization of excess amount of solvents, thus, making the product prone to instability, and may also cause harmful side effects in patients. Scale up is critical and involves the investment of huge capital and time. Lately, hot-melt extrusion has been utilized in the development of MCS to enhance solubility, bioavailability, stability, and physicochemical properties of the drugs. In this review, the authors discussed the development of different MCS produced via hot-melt extrusion technology. Specifically, approaches for screening of co-formers and co-crystals, selection of excipients for co-amorphous systems, pharmaceutical salts, and significance of MCS and process parameters affecting product quality are discussed.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jddst.2020.102209DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7946067PMC
February 2021
-->