Development of controlled release tablet by optimizing HPMC: Consideration of theoretical release and RSM

Pani, Nihar Ranjan; Nath, Lila Kanta

doi:10.1016/j.carbpol.2014.01.037

Cited by 16 publications

(5 citation statements)

References 24 publications

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“…It can significantly affect the release kinetics of APAP due to its high swellability (Siepmann and Peppas, 2012). Once the tablets contact the dissolution media, the polymer chain will have relaxed with volume expansion, thus it diffuses into the matrix (Brannon-Peppas and Peppas, 1991), then, the APAP diffuses out of the system (Pani & Nath, 2014). HPMC E5 has an average molecular weight of 34,500 Da and normal viscosity of 4.0–6.0 mPa·S.Soluplus ® was donated by BASF (Ludwigshafen, Germany) and is a co-polymer of polyethylene glycol, polyvinyl acetate, and polyvinylcaprolactam-based graft with an amphiphilic chemical structure, particularly developed for solid dispersions, which acts as a polymeric solubilizer.…”

Section: Methodsmentioning

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

166

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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: Methodsmentioning

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

166

View full text Add to dashboard Cite

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“…In vitro drug release was examined using the USP-XXIII dissolution apparatus-II, rotating paddle type with sinker (TDT-08L; Electrolab, Mumbai, India) operated with 50 rpm paddle speed at 37 ± 0.5°C. The dissolution medium employed was 900 ml of 0.1 M HCl for a period of 24 h. 7 The sink condition was preserved during the entire study. Samples of 5 ml were withdrawn and filtered through 0.45μ PTFE filters and analysed spectrophotometrically by measuring the absorbance at 272 nm.…”

Section: In Vitro Drug Release Studiesmentioning

confidence: 99%

Optimization and Analysis of Xanthan Gum and Hypromellose Combined Matrices for Extended Release of Ranolazine Using Quality by Design

Sowmya

Kumar

Adhikari³

2022

IJPI

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Background: Xanthan gum (XG) is a natural polymer with numerous uses. But its poor tableting and release charact1eristics reduce its usage as a tablet matrix former. Hence, the aim of the study is to improve the quality of XG by blending it with a successful semisynthetic polymer, hypromellose (HPMC). Methods: Extended release (ER) tablets were made using wet granulation technique using XG and HPMC blend. The blend was optimised using Central composite design. Prepared tablets were evaluated for in vitro tableting characteristics and drug release. In vivo absorption studies are carried out in New Zealand white rabbits. Results: Under optimal conditions, the ideal combination of factors was observed in the range of X 1 : 2.75-4.25 %w/w and X 2 : 10-20% w/w. At these finest concentrations, the predictable responses, the drug release at 4 th hr was 36.31-40.34%, 20 th hr was 82.21-91.43% and the hardness of the tablet was 6.6-8.5 kg/Cm 2 . The drug release of the optimized batch (RANERT 14) showed 90.9% similarity with the standard commercial ER tablets. Further, in vivo pharmacokinetic testing of the same batch showed, bioavailability (88.0 ±2.5%), mean residence time (16.1± 2.85 h) and biological half-life (11.47 ±0.42 h) against pure drug (BA: 65.0 4%; MRT: 5.1± 2.85 h; t1/2: 2.6151 ± 0.54 h). Conclusion: Comparable drug release profiles with the commercial tablets and enhanced pharmacokinetic profile made this combination as successful in achieving extended-release for a period of 24 hr by overcoming the drawbacks associated with XG.

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“…In the present case, the HPMC hydrates, swells and forms a hydrogel layer that controls directly the diffusion and indirectly the dissolution of indapamide. The system is not purely diffusional, concurrent erosion arises after polymer chain disentanglement [39]. Chemically HPMC is a semi-synthetic polymer, with methoxyl and hydroxypropoxyl substituents attached to the cellulosic backbone.…”

Section: Extended Root Cause Analysis Via O2plsmentioning

confidence: 99%

Applying the Principles of Quality by Design (Qbd) Coupled With Multivariate Data Analysis (Mvda) in Establishing the Impact of Raw Material Variability for Extended Release Tablets

Ilyés¹

2021

FARMACIA

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The raw material is acknowledged to be a source of variability, however, the conventional, empirical development approach does not offer much information regarding its critical attributes and how processes can be modulated to remain in the constant quality region of the product. The study aimed to develop extended release hydrophilic matrix tablets with indapamide based on the Quality by Design (QbD) concept, evaluating the impact of interchanging different types and suppliers of raw material on the finished product quality profile. Results showed significant in vitro release test variability, with 16 -71% failure rates when compared to four different EMA and FDA dissolution specification recommendations. Design of experiments based impact assessment concluded that the active pharmaceutical ingredient, hydroxypropyl methylcellulose and compression force was accountable for the variation, while orthogonal partial least squares (O2PLS) based root cause analysis extension redefined results in term of critical material attributes. Findings suggest that a risk-based, multivariate analysis assisted control strategy for the incoming raw materials could prevent quality concerns within routine manufacturing. RezumatMateria primă este recunoscută a fi o sursă de variabilitate, totuși abordarea de dezvoltare empirică, convențională nu oferă multe informații cu privire la atributele critice și modul în care procesele pot fi modulate pentru a rămâne în regiunea de calitate constantă a produsului. Studiul propune dezvoltarea de comprimate cu indapamidă de tip matrice hidrofilă cu eliberare prelungită pe baza conceptului de calitate prin design (Quality by Design -QbD), cu evaluare concomitentă a impactulului materiilor prime asupra calității finale. Rezultatele au evidențiat o variabilitate semnificativă în cadrul testului de eliberare in vitro, cu rate de eșec între 16 -71% în comparație cu patru recomandări diferite privind specificațiile de dizolvare EMA și FDA. Evaluarea impactului pe baza metodei planurilor experimentale a concluzionat că substanța activă, hidroxipropil metilceluloza și forța de comprimare ar fi responsabile pentru variație, în timp ce identificarea cauzei prin metoda celor mai mici pătrate ortogonale (O2PLS) a redefinit rezultele în termenii atributelor critice ale materialelor. Concluziile sugerează că o strategie de control, bazată pe analiza multivariată, ar putea preveni problemele de calitate din cadrul unei producții de rutină.

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Development of controlled release tablet by optimizing HPMC: Consideration of theoretical release and RSM

Cited by 16 publications

References 24 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

Optimization and Analysis of Xanthan Gum and Hypromellose Combined Matrices for Extended Release of Ranolazine Using Quality by Design

Applying the Principles of Quality by Design (Qbd) Coupled With Multivariate Data Analysis (Mvda) in Establishing the Impact of Raw Material Variability for Extended Release Tablets

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