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Production of extended release mini-tablets using directly compressible grades of HPMC.
Drug Dev Ind Pharm. 2013 Nov; 39(11):1690-7.DD

Abstract

CONTEXT

Hypromellose (HPMC) has been previously used to control drug release from mini-tablets. However, owing to poor flow, production of mini-tablets containing high HPMC levels is challenging. Directly compressible (DC) HPMC grades have been developed by Dow Chemical Company.

OBJECTIVE

To compare the properties of HPMC DC (METHOCEL™ K4M and K100M) with regular (REG) HPMC grades.

METHOD

Particle size distribution and flowability of HPMC REG and DC were evaluated. 3 mm mini-tablets, containing hydrocortisone or theophylline as model drugs and 40% w/w HPMC DC or REG were produced. Mini-tablets containing HPMC DC grades were manufactured using a rotary press simulator at forces between 2-4 kN and speeds of 5, 10, 15 or 20 rpm. Mini-tablets containing HPMC REG were produced manually.

RESULTS AND DISCUSSION

The improved flowability of HPMC DC grades, which have a narrower particle size distribution and larger particle sizes, meant that simulated large scale production of mini-tablets with good weight uniformity (CV 1.79-4.65%) was feasible. It was not possible to automatically manufacture mini-tablets containing HPMC REG due to the poor flowability of the formulations. Drug release from mini-tablets comprising HPMC DC and REG were comparable. Mini-tablets containing HPMC DC illustrated a higher tensile strength compared to mini-tablets made with HPMC REG. Mini-tablets produced with HPMC DC at different compression speeds had similar drug release profiles.

CONCLUSIONS

Production of extended release mini-tablets was successfully achieved when HPMC DC was used. Drug release rate was not influenced by the different HPMC DC grades (K4M or K100M) or production speed.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Mohamed FA
School of Pharmacy & Biomolecular Sciences, Liverpool John Moores University , Liverpool , UK.
Roberts M
No affiliation info available
Seton L
No affiliation info available
Ford JL
No affiliation info available
Levina M
No affiliation info available
Rajabi-Siahboomi AR
No affiliation info available

MeSH

Anti-Inflammatory AgentsBronchodilator AgentsChemical PhenomenaDelayed-Action PreparationsDrug CompoundingExcipientsHydrocortisoneHypromellose DerivativesKineticsMechanical PhenomenaMethylcelluloseMicroscopy, Electron, ScanningModels, MolecularParticle SizeQuality ControlSolubilitySurface PropertiesTabletsTensile StrengthTheophylline

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

23078551

Citation

Mohamed, Faiezah A A., et al. "Production of Extended Release Mini-tablets Using Directly Compressible Grades of HPMC." Drug Development and Industrial Pharmacy, vol. 39, no. 11, 2013, pp. 1690-7.
Mohamed FA, Roberts M, Seton L, et al. Production of extended release mini-tablets using directly compressible grades of HPMC. Drug Dev Ind Pharm. 2013;39(11):1690-7.
Mohamed, F. A., Roberts, M., Seton, L., Ford, J. L., Levina, M., & Rajabi-Siahboomi, A. R. (2013). Production of extended release mini-tablets using directly compressible grades of HPMC. Drug Development and Industrial Pharmacy, 39(11), 1690-7. https://doi.org/10.3109/03639045.2012.730524
Mohamed FA, et al. Production of Extended Release Mini-tablets Using Directly Compressible Grades of HPMC. Drug Dev Ind Pharm. 2013;39(11):1690-7. PubMed PMID: 23078551.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Production of extended release mini-tablets using directly compressible grades of HPMC. AU - Mohamed,Faiezah A A, AU - Roberts,Matthew, AU - Seton,Linda, AU - Ford,James L, AU - Levina,Marina, AU - Rajabi-Siahboomi,Ali R, Y1 - 2012/10/19/ PY - 2012/10/20/entrez PY - 2012/10/20/pubmed PY - 2014/5/16/medline SP - 1690 EP - 7 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 39 IS - 11 N2 - CONTEXT: Hypromellose (HPMC) has been previously used to control drug release from mini-tablets. However, owing to poor flow, production of mini-tablets containing high HPMC levels is challenging. Directly compressible (DC) HPMC grades have been developed by Dow Chemical Company. OBJECTIVE: To compare the properties of HPMC DC (METHOCEL™ K4M and K100M) with regular (REG) HPMC grades. METHOD: Particle size distribution and flowability of HPMC REG and DC were evaluated. 3 mm mini-tablets, containing hydrocortisone or theophylline as model drugs and 40% w/w HPMC DC or REG were produced. Mini-tablets containing HPMC DC grades were manufactured using a rotary press simulator at forces between 2-4 kN and speeds of 5, 10, 15 or 20 rpm. Mini-tablets containing HPMC REG were produced manually. RESULTS AND DISCUSSION: The improved flowability of HPMC DC grades, which have a narrower particle size distribution and larger particle sizes, meant that simulated large scale production of mini-tablets with good weight uniformity (CV 1.79-4.65%) was feasible. It was not possible to automatically manufacture mini-tablets containing HPMC REG due to the poor flowability of the formulations. Drug release from mini-tablets comprising HPMC DC and REG were comparable. Mini-tablets containing HPMC DC illustrated a higher tensile strength compared to mini-tablets made with HPMC REG. Mini-tablets produced with HPMC DC at different compression speeds had similar drug release profiles. CONCLUSIONS: Production of extended release mini-tablets was successfully achieved when HPMC DC was used. Drug release rate was not influenced by the different HPMC DC grades (K4M or K100M) or production speed. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/23078551/Production_of_extended_release_mini_tablets_using_directly_compressible_grades_of_HPMC_ DB - PRIME DP - Unbound Medicine ER -