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Application of Twin-Screw Melt Granulation to Overcome the Poor Tabletability of a High Dose Drug.
Pharm Res. 2022 Dec; 39(12):3241-3257.PR

Abstract

Pharmaceutical tablet manufacturing has seen a paradigm shift toward continuous manufacturing and twin-screw granulation-based technologies have catalyzed this shift. Twin-screw granulator can simultaneously perform unit operations like mixing, granulation, and drying of the granules. The present study investigates the impact of polymer concentration and processing parameters of twin-screw melt granulation, on flow properties and compaction characteristics of a model drug having high dose and poor tabletability. Acetaminophen (AAP) and polyvinylpyrrolidone vinyl acetate (PVPVA) were used as a model drug (90-95% w/w) and polymeric binder (5-10%w/w), respectively, for the current study. Feed rate (~650-1150 g/h), extruder screw speed (150-300 rpm), and temperature (60-150°C) were used as processing variables. Results showed the reduction in particle size of drug in the extrudates (D90 of 15-25 μm from ~80 μm), irrespective of processing condition, while flow properties were a function of polymer concentration. Overall, good flowability of the products and their tablets with optimum tensile strength can be obtained through using high polymer concentration (i.e., 10% w/w), lower feed rate (~650 g/h), lower extruder screw speed (150 rpm), and higher processing temperatures (up to 120°C). The findings from the current study can be useful for continuous manufacturing of tablets of high dose drugs with minimal excipient loading in the final dosage form.

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Authors+Show Affiliations

Thakore SD
Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Sector 67, S.A.S. Nagar, Mohali, Punjab, 160062, India.
Reddy KV
Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Sector 67, S.A.S. Nagar, Mohali, Punjab, 160062, India.
Dantuluri AK
Ashland (India) Pvt. Ltd., MN Park Synergy Square 3, Building No.2700, II Floor, Lalgadi Malakpet Village, Turkapally, Shamirpet, Hyderabad, Telangana, 500078, India.
Patel D
Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Sector 67, S.A.S. Nagar, Mohali, Punjab, 160062, India.
Kumawat A
DryProTech lab, Chemical Engineering, Indian Institute of Technology-Gandhinagar, Palaj, Gujarat, 382355, India.
Sihorkar V
Ashland (India) Pvt. Ltd., MN Park Synergy Square 3, Building No.2700, II Floor, Lalgadi Malakpet Village, Turkapally, Shamirpet, Hyderabad, Telangana, 500078, India. Sai Life Sciences Ltd, L4-01 & 02, SLN Terminus Survey No. 133, Gachibowli- Miyapur Rd, Gachibowli, Telangana, 500032, India.
Ghoroi C
DryProTech lab, Chemical Engineering, Indian Institute of Technology-Gandhinagar, Palaj, Gujarat, 382355, India.
Bansal AK
Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Sector 67, S.A.S. Nagar, Mohali, Punjab, 160062, India. akbansal@niper.ac.in.

MeSH

Drug CompoundingAcetaminophenPolymersExcipientsTabletsParticle SizeTechnology, Pharmaceutical

Pub Type(s)

Journal Article

Language

eng

PubMed ID

36002616

Citation

Thakore, Samarth D., et al. "Application of Twin-Screw Melt Granulation to Overcome the Poor Tabletability of a High Dose Drug." Pharmaceutical Research, vol. 39, no. 12, 2022, pp. 3241-3257.
Thakore SD, Reddy KV, Dantuluri AK, et al. Application of Twin-Screw Melt Granulation to Overcome the Poor Tabletability of a High Dose Drug. Pharm Res. 2022;39(12):3241-3257.
Thakore, S. D., Reddy, K. V., Dantuluri, A. K., Patel, D., Kumawat, A., Sihorkar, V., Ghoroi, C., & Bansal, A. K. (2022). Application of Twin-Screw Melt Granulation to Overcome the Poor Tabletability of a High Dose Drug. Pharmaceutical Research, 39(12), 3241-3257. https://doi.org/10.1007/s11095-022-03369-w
Thakore SD, et al. Application of Twin-Screw Melt Granulation to Overcome the Poor Tabletability of a High Dose Drug. Pharm Res. 2022;39(12):3241-3257. PubMed PMID: 36002616.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Application of Twin-Screw Melt Granulation to Overcome the Poor Tabletability of a High Dose Drug. AU - Thakore,Samarth D, AU - Reddy,Katangur Vishruth, AU - Dantuluri,Ajay K, AU - Patel,Deepika, AU - Kumawat,Akshant, AU - Sihorkar,Vaibhav, AU - Ghoroi,Chinmay, AU - Bansal,Arvind K, Y1 - 2022/08/25/ PY - 2022/01/09/received PY - 2022/08/14/accepted PY - 2022/8/25/pubmed PY - 2022/8/25/medline PY - 2022/8/24/entrez KW - Acetaminophen KW - Polyvinylpyrrolidone vinyl acetate KW - Tabletability KW - Twin-screw melt granulation SP - 3241 EP - 3257 JF - Pharmaceutical research JO - Pharm Res VL - 39 IS - 12 N2 - Pharmaceutical tablet manufacturing has seen a paradigm shift toward continuous manufacturing and twin-screw granulation-based technologies have catalyzed this shift. Twin-screw granulator can simultaneously perform unit operations like mixing, granulation, and drying of the granules. The present study investigates the impact of polymer concentration and processing parameters of twin-screw melt granulation, on flow properties and compaction characteristics of a model drug having high dose and poor tabletability. Acetaminophen (AAP) and polyvinylpyrrolidone vinyl acetate (PVPVA) were used as a model drug (90-95% w/w) and polymeric binder (5-10%w/w), respectively, for the current study. Feed rate (~650-1150 g/h), extruder screw speed (150-300 rpm), and temperature (60-150°C) were used as processing variables. Results showed the reduction in particle size of drug in the extrudates (D90 of 15-25 μm from ~80 μm), irrespective of processing condition, while flow properties were a function of polymer concentration. Overall, good flowability of the products and their tablets with optimum tensile strength can be obtained through using high polymer concentration (i.e., 10% w/w), lower feed rate (~650 g/h), lower extruder screw speed (150 rpm), and higher processing temperatures (up to 120°C). The findings from the current study can be useful for continuous manufacturing of tablets of high dose drugs with minimal excipient loading in the final dosage form. SN - 1573-904X UR - https://www.unboundmedicine.com/medline/citation/36002616/Application_of_Twin_Screw_Melt_Granulation_to_Overcome_the_Poor_Tabletability_of_a_High_Dose_Drug_ DB - PRIME DP - Unbound Medicine ER -