Didanosine extended-release matrix tablets: optimization of formulation variables using statistical experimental design

Sánchez-Lafuente, Carla; Furlanetto, Sandra; Fernández‐Arévalo, M.; Álvarez-Fuentes, Josefa; Rabasco, A. M.; Faucci, Maria Teresa; Pinzauti, S.; Mura, Paola

doi:10.1016/s0378-5173(02)00028-5

Cited by 69 publications

(25 citation statements)

References 11 publications

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“…A similar procedure can be used in formulation development to identify CPIs (material/intermediate attributes, manufacturing parameters, etc.) that influence the release profile of the product and which can be controlled to ensure final drug product quality (123,124).…”

Section: The Application Of Qbd Principles To Dissolution Methods Devementioning

confidence: 99%

The Science of USP 1 and 2 Dissolution: Present Challenges and Future Relevance

Gray¹,

et al. 2009

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Since its inception, the dissolution test has come under increasing levels of scrutiny regarding its relevance, especially to the correlation of results to levels of drug in blood. The technique is discussed, limited to solid oral dosage forms, beginning with the scientific origins of the dissolution test, followed by a discussion of the roles of dissolution in product development, consistent batch manufacture (QC release), and stability testing. The ultimate role of dissolution testing, "to have the results correlated to in vivo results or in vivo in vitro correlation," is reviewed. The recent debate on mechanical calibration versus performance testing using USP calibrator tablets is presented, followed by a discussion of variability and hydrodynamics of USP Apparatus 1 and Apparatus 2. Finally, the future of dissolution testing is discussed in terms of new initiatives in the industry such as quality by design (QbD), process analytical technology (PAT), and design of experiments (DOE).

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Section: The Application Of Qbd Principles To Dissolution Methods Devementioning

confidence: 99%

The Science of USP 1 and 2 Dissolution: Present Challenges and Future Relevance

Gray¹,

et al. 2009

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“…Response Surface Methodology (RSM) is a collection of statistical and mathematical techniques useful for developing; improving and optimizing processes. There are different types of RSM designs, such as 3-level factorial design, central composite design (CCD) [14], Box-Behnken design [15], and Doptimal design [16]. RSM has been successfully utilized to optimize the compositions of microbiological media and improving solid state fermentation process [17].…”

Section: Research Papermentioning

confidence: 99%

Parameter optimization for production of ligninolytic enzymes using agro-industrial wastes by response surface method

Gassara

Brar

Tyagi

et al. 2011

Biotechnol Bioproc E

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Lignin and manganese peroxidase (LiP, MnP) and laccase production by Phanerocheate chrysosporium was optimized by response surface methodology for brewery waste and apple pomace. The effect of moisture, copper sulphate, and veratryl alcohol (VA) concentrations on enzyme production was studied. Moisture and VA had significant positive effect on MnP and LiP production and the viability of P. chrysosporium (p < 0.05) and copper sulphate produced a negative effect. However, moisture and copper sulphate had a significant positive (p < 0.05) effect on laccase production, but VA had an insignificant positive effect (p < 0.05). Higher values of MnP, LiP and viability of P. chrysosporium on apple pomace (1287.5 U MnP/gds (units/gram dry substrate), 305 U LiP/gds, and 10.38 Log 10 viability) and brewery waste (792 U MnP/gds and 9.83 Log 10 viability) were obtained with 80% moisture, 3 mmol/kg VA, and 0.5 mmol/kg copper. LiP production in brewery waste (7.87 U/gds) was maximal at 70% moisture, 2 mmol/kg VA, and 1 mmol/kg copper. Higher production of laccase in apple pomace (789 U/gds) and brewery waste (841 U/gds) were obtained with 80% moisture, 3 mmol/kg VA, and 1.5 mmol/kg copper. Thus, moisture along with VA and copper sulphate was pertinent for the production of ligninolytic enzymes and increased cell viability.

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“…1 However, active pharmaceutiexert the desired control of drug release from such systems. 2 From various reports on controlled-release systems published in the literature, [5][6][7][8][9][10][11][12] it is evident that at least 50% of the components in a tablet should be release-controlling polymers and other excipients and that the development of a formulation becomes very difficult, if not impossible, if at least 30-40% of the weight is not release-controlling polymers.…”

Section: Introductionmentioning

confidence: 99%