NIR Prediction of Solid Dosage Form Dissolution Profiles

Mattes, Robert A.; Root, Denise; Zhou, Yinqi; Xiao, Chaoju; Johnson, James R.; Shukla, Atul

doi:10.1255/nirn.1136

Cited by 1 publication

(2 citation statements)

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“…1,2 This rapid testing has successfully modeled dissolution testing for continuous manufacturing applications for simple formulations. [1][2][3][4][5][6][7] The Food and Drug Administration recognizes this capability and cites examples of real-time release testing (RTRT), which includes "multivariate analysis models as a surrogate for dissolution." 8 Use of such models is not as simple as submitting a traditional method and validation.…”

Section: Introductionmentioning

confidence: 99%

“…Thus, if a Raman library could distinguish between, dissolution release changes due to hardness, lubricants, particle sizes, etc., the spectroscopic tool could serve as a surrogate for lengthy dissolution testing similar to the earlier work using near-infrared for continuous manufacturing. 3,4 Such modeling would require a much larger body of data for the spectral library.…”

Section: Introductionmentioning

confidence: 99%

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Opportunities and Challenges: Process Raman for the Real-Time Release Testing (RTRT) of Extended-Release Formulations

Webster,

Mankani,

Mozharov

et al. 2024

Applied Spectroscopy Practica

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The use of a process analytical technology has been demonstrated using near-infrared spectroscopy for continuous manufacturing of pharmaceutical formulations and is within the scope of the U.S. Food and Drug Administration's real-time release testing initiative. While effective for simple formulations, this preliminary study investigates whether such a spectroscopic surrogate application can replace pharmaceutical dissolution testing for extended-release formulations. In this study, we will assess the use of process Raman spectroscopy for real-time dissolution testing. Extended-release tablet formulations often accomplish the release rate delay through the addition of gelling agents. In this work, hydroxypropyl methylcellulose (HPMC) polymers were used to formulate extended-release niacin tablets. Process Raman spectroscopy was evaluated as a tool to effectively model dissolution profiles to determine if the optical technique has the ability to differentiate HPMC polymers from the background and be selective for the polymer type employed. Our preliminary work indicates that while Raman can effectively detect and monitor the niacin response of the tablet formulations, there are not enough unique spectral features between the different HPMC polymers to selectively resolve their responses. Additional measurements and chemometric analysis might suggest otherwise. Thus, for extended-release tablet applications with continuous manufacturing, further dissolution surrogate development is needed.

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