Showing posts with label quality by design. Show all posts
Showing posts with label quality by design. Show all posts

Tuesday, 28 October 2025

Personalised Medicine: From Genomics to 3D-Printed Pharmaceuticals | Chapter 1 | Medical Science: Updates and Prospects Vol. 1

 

Personalised medicine (PM) is a patient-specific approach to treatment that integrates genetic, epigenomic, and clinical data. PM has the potential to transform traditional medical practice by tailoring therapies to individual genetic profiles. The significant advantages and limitations must be carefully considered. Manufacturers are using drug repurposing, biomarker-driven R&D, and collaborations with diagnostics and IT sectors. Personalised medicine not only enhances therapeutic precision but also advances preventive care through polygenic risk scores and early biomarker detection. The integration of digital health tools, including wearables and telemedicine, further supports patient-specific monitoring. Real-world examples, such as FDA-approved targeted therapies and CAR-T cells, illustrate its transformative potential. Innovations such as CRISPR-based interventions, AI-driven decision support, and personalised vaccines are highlighted. Liquid biopsy, single-cell omics, artificial intelligence, and healthcare digitalisation, further supporting its implementation, are cutting-edge tools. The Quality by Design (QbD) principles for safe, consistent, and effective production of personalised 3D-printed tablets have been explained. Critical material attributes (CMAs), critical process parameters (CPPs), and critical quality attributes (CQAs) together enable regulatory-compliant manufacturing by ensuring drug dosage accuracy, content uniformity, dissolution control, and robust production conditions. Beyond treatment, it raises ethical considerations related to data privacy and equitable access. Although cost-intensive, it reduces long-term healthcare burdens by minimising adverse reactions.

 

 

Author(s) Details

B. Navya Sree
Arya College of Pharmacy, India.

 

Saif Bin Salim
Arya College of Pharmacy, India.

 

Mohd Abdul Kareem
Arya College of Pharmacy, India.

 

M. Srikanth
Arya College of Pharmacy, India.

 

 

AVS Rajeswari
Department of Pharmaceutics, Arya College of Pharmacy, India.

 

Please see the book here :- https://doi.org/10.9734/bpi/msup/v1/6352

 

Thursday, 19 August 2021

Analytical Tools- Driven Compatibility and Processing Methods Study: A Case of ArtemetherLumefantrine Fixed Dose Combination Formulation| Chapter 3| Current Approaches in Science and Technology Research Vol. 13

 Artemisinin-based Combination Therapies (ACTs), particularly artemether and lumefantrine fixed dose combination, have been widely praised and recommended as a first-line treatment for uncomplicated falciparum malaria: The goal of this study was to figure out the best technique to use artemether-lumefantrine (AL) as model pharmaceuticals without compromising quality during processing. Analytical instruments indicated how quality was achieved by monitoring and controlling the compatibility of formulation components and the applicability of process procedures.outcome. Excipients with demonstrated performance in the wet granulation method, as well as AL as a model medication, were incorporated into six formulations, which were coded F-1 to F-6 to reflect ways of inclusion. Fourier Transform Infrared (FTIR), Differential Scanning Calorimetry (DSC), and High Performance Liquid Chromatography (HPLC) techniques were used to screen physical mixtures and wet granulated samples at various stages of processing for compatibility and method applicability as in-process materials. These instruments properly addressed the assessment of potential risks inherent in formulation and process unit operations.The matching and comparison of spectra, thermograms, and chromatograms at various stages of processing revealed no disappearance of old or appearance of new spectral bands, as well as a reduction in melting endotherm and similar characteristic elution times of AL as they transitioned from pure material to physical mixture (PM) and finally to granules. The results of this study indicated that the formulation components were compatible and that the processing techniques were suitable to the degree that the resulting granulates were suitable for further processing.




Author (S) Details

Musibau A. Mustapha
Tafapharm Limited Box 3254, Agege Post Office, Agege, Lagos, Nigeria



View Book :https://stm.bookpi.org/CASTR-V13/article/view/2800