Emerging technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality

O’Connor, Thomas; Yu, Lawrence X.; Lee, Sau L.

doi:10.1016/j.ijpharm.2016.05.058

Cited by 62 publications

(33 citation statements)

References 5 publications

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“…In addition, combining the technologies reduces the required downstream processing, making it more efficient and economical. The Food and Drug Administration (FDA) has recently encouraged the production of oral solid dosages that meet the increasing demands of oral drug delivery in terms of API bioavailability and drug release characteristics, in a continuous and controlled process (O'Connor, Lawrence, & Lee, 2016). …”

Section: Introductionmentioning

confidence: 99%

Hydroxypropyl methylcellulose-based controlled release dosage by melt extrusion and 3D printing: Structure and drug release correlation

Zhang

Yang

et al. 2017

Carbohydrate Polymers

161

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The objective of this study was to develop a new approach for fabrication of zero order release of active pharmaceutical ingredients (APIs) using hot-melt extrusion (HME) and 3D printing technology to generate tablets with specific 3D structures. By correlating the geometry of the 3D printed tablets with their dissolution and drug release rates, mathematical models that have been developed to describe drug release mechanisms were also studied. Acetaminophen was used as a model drug, and Benecel™ hydroxypropyl methylcellulose (HPMC) E5 and Soluplus® were used to formulate nine fuse depositional 3D-printed tablets with different inner core fill densities and outside shell thicknesses. This work reports the successful fabrication of solid-dispersion filaments with an API dispersed in HPMC based matrix via HME technology, and the production of zero order controlled release tablets with different 3D structures (tablets #3, 5, 6, and 9) using a 3D printer.

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Section: Introductionmentioning

confidence: 99%

Hydroxypropyl methylcellulose-based controlled release dosage by melt extrusion and 3D printing: Structure and drug release correlation

Zhang

Yang

et al. 2017

Carbohydrate Polymers

161

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“…Furthermore, the sampling for this study was completed prior to several of the FDA’s efforts to improve drug quality. 21 , 22 , 23 , 24 This study focused on prescription pharmaceuticals legally marketed in the US. The safety of counterfeit drugs or drugs purchased online cannot be guaranteed and may present consumers with a health risk from substandard products.…”

Section: Discussionmentioning

confidence: 99%

Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US

et al. 2020

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Key Points Question Are there substantive differences in the major quality attributes of difficult-to-make pharmaceutical products manufactured throughout the world and marketed in the US? Findings In this quality improvement study, all of 252 drug product samples met the US market standards for the major quality attributes of dosage unit uniformity and dissolution, although there was evidence of differences in the consistency of these attributes among regions and manufacturers. Meaning These findings suggest that difficult-to-make prescription pharmaceuticals marketed in the US consistently meet quality standards even when manufactured outside the US.

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“…The FDA's initiatives include advancement of regulatory science in emerging technologies, as well as leveraging external expertise and promoting international harmonization efforts in this field with other health authorities. 169 Harmonization is critical to expedite adoption by industry because most manufacturing facilities supply drug product globally and therefore need to comply with often disparate requirements from health authorities who are at different stages of understanding and acceptance of specific novel technology.…”

Section: Considerations For Use Of Novel Technologiesmentioning

confidence: 99%

Innovation in Chemistry, Manufacturing, and Controls—A Regulatory Perspective From Industry

Cauchon

Oghamian

Hassanpour

et al. 2019

Journal of Pharmaceutical Sciences

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This review describes the landscape of novel modalities such as cell and gene therapies, viruses, other novel biologics, oligomers, and emerging technologies, including modern analytics. We summarize the regulatory history and recent landmark developments in some major markets and examine specific chemistry, manufacturing, and controls (CMC) challenges, including suggestions for exploration of potential science-based approaches in support of regulatory strategy development from an industry perspective. In addition, we evaluate the economic factors contributing to patient access to innovation and discuss the impact of regulation. There is a desperate need for a consistent form of regulation where global approaches to regulatory strategies can be harmonized, and specific CMC challenges can be dealt with using the appropriate science and risk-based tools. Although these tools are well described in current guidance documents, the specifics of applicability to complex novel modalities can still result in differing regulatory advice and outcomes. The future goals for efficiently regulating innovative modalities and technologies could be aided by more regulatory harmonization, regulatory education, and industry cooperation through consortia, enabling industry to supply key information to regulators in a transparent yet well-defined manner, and utilizing mutually understood risk-benefit analyses to produce drugs with appropriate safety, efficacy, and quality characteristics.

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Emerging technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality

Cited by 62 publications

References 5 publications

Hydroxypropyl methylcellulose-based controlled release dosage by melt extrusion and 3D printing: Structure and drug release correlation

Hydroxypropyl methylcellulose-based controlled release dosage by melt extrusion and 3D printing: Structure and drug release correlation

Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US

Innovation in Chemistry, Manufacturing, and Controls—A Regulatory Perspective From Industry

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