Quality by design approach to the development of transdermal patch systems and regulatory perspective

Kim, Young Ho; Choi, Du Hyung

doi:10.1007/s40005-021-00536-w

Cited by 12 publications

(5 citation statements)

References 146 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Following the principles of QbD, pharmaceutical development starts with the establishment of the quality target product profile (QTPP). This encompasses the desired attributes related to quality, effectiveness, and safety (Kim and Choi, 2021;Simões et al, 2019). Based on the quality prospects, scientific knowledge, and research interpretations, the QTPP is defined in Table 4.…”

Section: Definition Of the Quality Target Product Profilementioning

confidence: 99%

Microfluidic-on-a-chip for designing celecoxib-based amorphous solid dispersions: when the process shapes the product

Figueiredo,

Mendes,

Pais

et al. 2024

Preprint

View full text Add to dashboard Cite

The fundamental idea underlying the use of amorphous solid dispersions (ASDs) is to make the most of the solubility advantage of the amorphous form of a drug. However, the drug stability becomes compromised due to the higher free energy and disorder of molecular packing in the amorphous phase, leading to crystallization. To overcome the stability concern, polymers are used as a matrix to form a stable homogeneous amorphous system. The present work aims to design ASD-based formulations under the quality umbrella by design principles for improving oral drug bioavailability, using celecoxib (CXB) as a model drug. ASDs were prepared from selected polymers and tested both individually and in combinations, using various manufacturing techniques: high-shear homogenization, high-pressure homogenization, microfluidic-on-a-chip, and spray-drying. The resulting dispersions were further optimized, resorting to a 32 full-factorial design, considering the API:Polymers ratio and the total solid content as variables. The formulated products were evaluated regarding analytical centrifugation and the influence of the different polymers on the intrinsic dissolution rate of the CXBASDs. Microfluidic-on-a-chip led to amorphous status of the formulation. The in vitro evaluation demonstrated a remarkable 26-fold enhancement in the intrinsic dissolution rate, and the translation of this formulation into tablets as the final dosage form is consistent with the observed performance enhancement. These findings are supported by ex vivo assays, which exhibited a two-fold increase in permeability compared to pure CXB. This study tackles the bioavailability hurdles encountered with diverse active compounds, offering insights into the development of more effective drug delivery platforms.

show abstract

Section: Definition Of the Quality Target Product Profilementioning

confidence: 99%

Microfluidic-on-a-chip for designing celecoxib-based amorphous solid dispersions: when the process shapes the product

Figueiredo,

Mendes,

Pais

et al. 2024

Preprint

View full text Add to dashboard Cite

show abstract

“…This will help pharmaceutical companies to improve the quality of their drugs. Therefore, the QbD method was established to streamline the research and development (R&D) process, increase process knowledge, and control capabilities to relieve and eventually solve this difficulty (30). A variety of case studies for the implementation of QbD in the development of numerous pharmaceutical products have been published in the literature.…”

Section: Contextmentioning

confidence: 99%

Quality by Design (QbD) Paradigm: An Integrated Multivariate Approach to Transdermal Patch System Development

2024

J Rep Pharm Sci

View full text Add to dashboard Cite

: The International Council on Harmonization issued quality by design (QbD) guidelines, including Q8 (R2) pharmaceutical development, Q9 quality risk management, and Q10 pharmaceutical quality system, to ensure the quality of pharmaceutical products. For continual and consistent improvement of the quality of pharmaceutical drug products, QbD tools, such as risk assessment, design of experiment, and control strategy, are used, which can solve the narrow areas in product development. Transdermal patch systems (TPS) are gaining attention among scientists and are one of the strong-growing drug delivery systems in the market as a result of numerous benefits, including lowering the dosing frequency, adverse effects and invasiveness, avoiding pre-systemic metabolism, and better patient efficiency and compatibility. Transdermal patch systems are a likable dosage form when compared to other dosage forms. However, several challenges are faced in TPS product development which has hindered enormous products concerning the market status of TPS in comparison to the oral dosage forms. The implementation of the QbD concept was much focused on oral dosage forms. Additionally, the lack of understanding of the development of TPS leads to failure and withdrawal from markets. Therefore, to understand the QbD concepts of TPS, an attempt has been made to review the QbD approach for the development of TPS from the identification of the Quality Target Product Profile to the arrival of design space, which might help the formulator to navigate the sticky areas, in the TPS development.

show abstract

“…The lack of the fundamental understanding of the theory of particle formation in SFEE following the lack of scientific analysis of experimental data for controlling fine particle formation from lab scale to scale-up can be compensated by studies using QbD-based approaches [93][94][95][96][97][98]. Thus, to achieve successful GMP scale-up and commercial mass production technology, it is essential to establish validated and robust technology through a scientific and statistical strategy based on the QbD approach [99,100]. In contrast to SFEE process in pharmaceutical field, extraction technology using SCF has already been used commercially in the food industry to extract effective active ingredients from natural raw materials or to selectively remove unwanted substances [101][102][103][104][105].…”

Section: Expert Opinions and Perspectivesmentioning

confidence: 99%

Pharmaceutical Applications of Supercritical Fluid Extraction of Emulsions for Micro-/Nanoparticle Formation

Park

Kim

et al. 2021

Pharmaceutics

View full text Add to dashboard Cite

Micro-/nanoparticle formulations containing drugs with or without various biocompatible excipients are widely used in the pharmaceutical field to improve the physicochemical and clinical properties of the final drug product. Among the various micro-/nanoparticle production technologies, emulsion-based particle formation is the most widely used because of its unique advantages such as uniform generation of spherical small particles and higher encapsulation efficiency (EE). For this emulsion-based micro-/nanoparticle technology, one of the most important factors is the extraction efficiency associated with the fast removal of the organic solvent. In consideration of this, a technology called supercritical fluid extraction of emulsions (SFEE) that uses the unique mass transfer mechanism and solvent power of a supercritical fluid (SCF) has been proposed to overcome the shortcomings of several conventional technologies such as solvent evaporation, extraction, and spray drying. This review article presents the main aspects of SFEE technology for the preparation of micro-/nanoparticles by focusing on its pharmaceutical applications, which have been organized and classified according to several types of drug delivery systems and active pharmaceutical ingredients. It was definitely confirmed that SFEE can be applied in a variety of drugs from water-soluble to poorly water-soluble. In addition, it has advantages such as low organic solvent residual, high EE, desirable release control, better particle size control, and agglomeration prevention through efficient and fast solvent removal compared to conventional micro-/nanoparticle technologies. Therefore, this review will be a good resource for determining the applicability of SFEE to obtain better pharmaceutical quality when researchers in related fields want to select a suitable manufacturing process for preparing desired micro-/nanoparticle drug delivery systems containing their active material.

show abstract

Quality by design approach to the development of transdermal patch systems and regulatory perspective

Cited by 12 publications

References 146 publications

Microfluidic-on-a-chip for designing celecoxib-based amorphous solid dispersions: when the process shapes the product

Microfluidic-on-a-chip for designing celecoxib-based amorphous solid dispersions: when the process shapes the product

Quality by Design (QbD) Paradigm: An Integrated Multivariate Approach to Transdermal Patch System Development

Pharmaceutical Applications of Supercritical Fluid Extraction of Emulsions for Micro-/Nanoparticle Formation

Contact Info

Product

Resources

About