Formulation Development and Evaluation of Injectable Depot Suspension

Bodhe, Roshan; Deshmukh, Rameshwar K.; Shinde, Rajendra D.; Patil, Kishor

doi:10.51521/ijmhr.2021.1105

Cited by 2 publications

(2 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Based on the physicochemical characteristics as well as the in vitro dissolution characteristics of the reference product, a quality target product profile (QTPP) was defined for the betamethasone suspension for injection formulation (Table 1). According to the QTPP and prior scientific knowledge about injectable suspension formulations, particle size distribution, viscosity, sedimentation time, density, and an assay of active substances and preservatives were considered as the CQAs of the betamethasone suspense on for injection formulation (Table 2) [15][16][17].…”

Section: Risk Identification: Ishikawa Diagrammentioning

confidence: 99%

Application of Plackett-Burman Design for Development and Evaluation of a Betamethasone Suspension for Injection Formulation

YERLİKAYA¹,

ARSLAN²,

ARABACI³

et al. 2023

Ankara Ecz. Fak. Derg.

View full text Add to dashboard Cite

Objective: In this study, a quality-by-design (QbD) approach was used to develop a betamethasone suspension for injection formulation and to investigate the possible effects of formulation and process variables on the critical quality attributes (CQAs) of the formulation. Material and Method: It was determined that the CQAs of the formulation were particle size distribution, viscosity, sedimentation time, density and assay of active substances and preservatives, considering the quality target product profile (QTPP). Potential risk factors that may affect the CQAs of the formulation were identified using an Ishikawa diagram, and a six-factor, two-level Plackett-Burman experimental design was used to statistically investigate the effects of selected formulation and process variables. The prepared formulations were tested, and variance and multiple linear regression analyses were performed with the acquired data Result and Discussion: As a result of the one-way analyses of variance (ANOVA) and multiple linear regression analyses, the established statistical models for the assay of methyl parahydroxybenzoate and propyl parahydroxybenzoate, and viscosity were found to be significant, the established models for other independent variables were not significant. The concentration of carmellose calcium and filter type was found to be the most significant formulation and process variables. In conclusion, this study showed that understanding the formulation and process variables that may affect the CQAs of injectable suspension formulations with a QbD approach could be useful for formulation development and optimization.

show abstract

Section: Risk Identification: Ishikawa Diagrammentioning

confidence: 99%

Application of Plackett-Burman Design for Development and Evaluation of a Betamethasone Suspension for Injection Formulation

YERLİKAYA¹,

ARSLAN²,

ARABACI³

et al. 2023

Ankara Ecz. Fak. Derg.

View full text Add to dashboard Cite

show abstract

“…The challenge is that dissolution studies for extended-release matrices often take several hours to execute. The application and transfer of methods using USP Apparatus I and II, 20,21 Apparatus III, [21][22][23] and Apparatus IV [24][25][26] could be replaced with rapid spectroscopic evaluation models that require only a few minutes. In addition, all samples going to the clinic could be effectively modeled.…”

Section: Introductionmentioning

confidence: 99%

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

View full text Add to dashboard Cite

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.

show abstract

Formulation Development and Evaluation of Injectable Depot Suspension

Cited by 2 publications

References 14 publications

Application of Plackett-Burman Design for Development and Evaluation of a Betamethasone Suspension for Injection Formulation

Application of Plackett-Burman Design for Development and Evaluation of a Betamethasone Suspension for Injection Formulation

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

Contact Info

Product

Resources

About