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Exploratory studies in heat-assisted continuous twin-screw dry granulation: A novel alternative technique to conventional dry granulation.
Int J Pharm. 2019 Jan 30; 555:380-393.IJ

Abstract

Dry granulation is the preferred technique for solvent-sensitive products, especially drugs with stability problems such as hydrolysis. Twin-screw granulation is a continuous granulation technique, offering a potential alternative to conventional dry granulation techniques such as roller compaction. The major advantage of twin-screw granulation is the ability to adjust process parameters of dry granulation without compromising the compression properties. This study was aimed to perform exploratory studies of heat-assisted continuous twin-screw dry granulation process to formulate sustained release tablets for APIs with different melting points: theophylline, acetaminophen and lidocaine hydrochloride hydrate. Granulation feasibility was studied with different binders (e.g. Klucel™ EF, Kollidon® VA64), sustained release agents (e.g. Klucel™ MF, Eudragit® RSPO) and diluents at various drug loads. The processing conditions were below the melting point or glass transition temperature of the formulation ingredients. After successful granulation, DSC and XRD studies revealed the crystalline nature of the granules and FTIR studies showed no interaction of the API with the excipients. The granules were compressed into sustained release tablets without any compressibility issues. The tablets were stable after testing for 6 months at 25 °C/60% RH. This novel continuous dry granulation technique may offer an excellent alternative to conventional dry granulation techniques.

Authors+Show Affiliations

Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, MS 38677, United States.Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, MS 38677, United States.Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, MS 38677, United States.Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, MS 38677, United States.Catalent Pharma Solutions, 14 School House Road, Somerset, NJ 08873, USA.Catalent Pharma Solutions, 14 School House Road, Somerset, NJ 08873, USA.Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, MS 38677, United States.College of Pharmacy, Kyungpook National University, Daegu 41566, South Korea.Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, MS 38677, United States.Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, MS 38677, United States; Pii Center for Pharmaceutical Technology, University of Mississippi, MS 38677, USA. Electronic address: marepka@olemiss.edu.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30458256

Citation

Kallakunta, Venkata Raman, et al. "Exploratory Studies in Heat-assisted Continuous Twin-screw Dry Granulation: a Novel Alternative Technique to Conventional Dry Granulation." International Journal of Pharmaceutics, vol. 555, 2019, pp. 380-393.
Kallakunta VR, Patil H, Tiwari R, et al. Exploratory studies in heat-assisted continuous twin-screw dry granulation: A novel alternative technique to conventional dry granulation. Int J Pharm. 2019;555:380-393.
Kallakunta, V. R., Patil, H., Tiwari, R., Ye, X., Upadhye, S., Vladyka, R. S., Sarabu, S., Kim, D. W., Bandari, S., & Repka, M. A. (2019). Exploratory studies in heat-assisted continuous twin-screw dry granulation: A novel alternative technique to conventional dry granulation. International Journal of Pharmaceutics, 555, 380-393. https://doi.org/10.1016/j.ijpharm.2018.11.045
Kallakunta VR, et al. Exploratory Studies in Heat-assisted Continuous Twin-screw Dry Granulation: a Novel Alternative Technique to Conventional Dry Granulation. Int J Pharm. 2019 Jan 30;555:380-393. PubMed PMID: 30458256.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Exploratory studies in heat-assisted continuous twin-screw dry granulation: A novel alternative technique to conventional dry granulation. AU - Kallakunta,Venkata Raman, AU - Patil,Hemlata, AU - Tiwari,Roshan, AU - Ye,Xingyou, AU - Upadhye,Sampada, AU - Vladyka,Ronald S, AU - Sarabu,Sandeep, AU - Kim,Dong Wuk, AU - Bandari,Suresh, AU - Repka,Michael A, Y1 - 2018/11/17/ PY - 2018/07/11/received PY - 2018/11/13/revised PY - 2018/11/16/accepted PY - 2018/11/21/pubmed PY - 2019/4/11/medline PY - 2018/11/21/entrez KW - Binder KW - Dry granulation KW - Glass transition temperature KW - Granule strength KW - Twin-screw granulation SP - 380 EP - 393 JF - International journal of pharmaceutics JO - Int J Pharm VL - 555 N2 - Dry granulation is the preferred technique for solvent-sensitive products, especially drugs with stability problems such as hydrolysis. Twin-screw granulation is a continuous granulation technique, offering a potential alternative to conventional dry granulation techniques such as roller compaction. The major advantage of twin-screw granulation is the ability to adjust process parameters of dry granulation without compromising the compression properties. This study was aimed to perform exploratory studies of heat-assisted continuous twin-screw dry granulation process to formulate sustained release tablets for APIs with different melting points: theophylline, acetaminophen and lidocaine hydrochloride hydrate. Granulation feasibility was studied with different binders (e.g. Klucel™ EF, Kollidon® VA64), sustained release agents (e.g. Klucel™ MF, Eudragit® RSPO) and diluents at various drug loads. The processing conditions were below the melting point or glass transition temperature of the formulation ingredients. After successful granulation, DSC and XRD studies revealed the crystalline nature of the granules and FTIR studies showed no interaction of the API with the excipients. The granules were compressed into sustained release tablets without any compressibility issues. The tablets were stable after testing for 6 months at 25 °C/60% RH. This novel continuous dry granulation technique may offer an excellent alternative to conventional dry granulation techniques. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/30458256/Exploratory_studies_in_heat_assisted_continuous_twin_screw_dry_granulation:_A_novel_alternative_technique_to_conventional_dry_granulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(18)30869-X DB - PRIME DP - Unbound Medicine ER -