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A Novel Technique to Improve Drug Loading Capacity of Fast/Extended Release Orally Dissolving Films with Potential for Paediatric and Geriatric Drug Delivery.
AAPS PharmSciTech. 2020 May 07; 21(4):126.AP

Abstract

Orally dissolving films (ODFs) have received much attention as potential oral drug delivery systems for paediatric and geriatric patients, particularly those suffering from dysphagia. With their unique properties and advantages, the technology offers improved patient compliance and wider acceptability, eliminates the fear of choking, enables ease of administration and offers dosing convenience, without the requirement of water. However, adequate drug loading remains a challenge. The aim of this study was to mechanistically design and evaluate fast and extended release ODF formulations with high drug loading capacity, displaying good physicochemical and mechanical properties, as a potential dosage form for paediatric and geriatric use employing a slightly soluble model drug-ibuprofen. Different polymers (0.6-10% HPMC, 0.6-1.5% guar gum), plasticisers (0.1-0.5% glycerine, 0.1% sorbitol) and processing conditions (40-60°C drying temperatures, 8-16 h drying times) were investigated to produce films using the solvent casting method. Molecular compatibility was assessed using TGA, XRD and FTIR whereas film topography was assessed using SEM. Maximum ibuprofen load in single films was 20.7 mg/film (54.4%) and released 100% drug content in 5 min, while triple layered ibuprofen-loaded films contained 62.2 mg/film and released 100% drug release in 1 h. The ODFs demonstrated good disintegration time using low volume artificial saliva media and high dosage from uniformity. This study provides a mechanistic insight to the design and evaluation of fast and extended release ODFs with high drug loading, suitable for administration to paediatric and geriatric patients.

Authors+Show Affiliations

Department of Applied Pharmaceutical Sciences and Clinical Pharmacy, School of Pharmacy, Isra University, Amman, Jordan.Department of Applied Pharmaceutical Sciences and Clinical Pharmacy, School of Pharmacy, Isra University, Amman, Jordan. eman.zmaily@iu.edu.jo.School of Pharmacy, Najran University, Najran, Saudi Arabia.School of Pharmacy, Aston University, Birmingham, UK.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32382992

Citation

Ouda, Gailany I., et al. "A Novel Technique to Improve Drug Loading Capacity of Fast/Extended Release Orally Dissolving Films With Potential for Paediatric and Geriatric Drug Delivery." AAPS PharmSciTech, vol. 21, no. 4, 2020, p. 126.
Ouda GI, Dahmash EZ, Alyami H, et al. A Novel Technique to Improve Drug Loading Capacity of Fast/Extended Release Orally Dissolving Films with Potential for Paediatric and Geriatric Drug Delivery. AAPS PharmSciTech. 2020;21(4):126.
Ouda, G. I., Dahmash, E. Z., Alyami, H., & Iyire, A. (2020). A Novel Technique to Improve Drug Loading Capacity of Fast/Extended Release Orally Dissolving Films with Potential for Paediatric and Geriatric Drug Delivery. AAPS PharmSciTech, 21(4), 126. https://doi.org/10.1208/s12249-020-01665-5
Ouda GI, et al. A Novel Technique to Improve Drug Loading Capacity of Fast/Extended Release Orally Dissolving Films With Potential for Paediatric and Geriatric Drug Delivery. AAPS PharmSciTech. 2020 May 7;21(4):126. PubMed PMID: 32382992.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Novel Technique to Improve Drug Loading Capacity of Fast/Extended Release Orally Dissolving Films with Potential for Paediatric and Geriatric Drug Delivery. AU - Ouda,Gailany I, AU - Dahmash,Eman Z, AU - Alyami,Hamad, AU - Iyire,Affiong, Y1 - 2020/05/07/ PY - 2019/12/13/received PY - 2020/03/21/accepted PY - 2020/5/9/entrez PY - 2020/5/10/pubmed PY - 2020/9/22/medline KW - drug load KW - extended-release films KW - fast-release films KW - geriatric formulations KW - orally dissolving films KW - paediatric formulations SP - 126 EP - 126 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 21 IS - 4 N2 - Orally dissolving films (ODFs) have received much attention as potential oral drug delivery systems for paediatric and geriatric patients, particularly those suffering from dysphagia. With their unique properties and advantages, the technology offers improved patient compliance and wider acceptability, eliminates the fear of choking, enables ease of administration and offers dosing convenience, without the requirement of water. However, adequate drug loading remains a challenge. The aim of this study was to mechanistically design and evaluate fast and extended release ODF formulations with high drug loading capacity, displaying good physicochemical and mechanical properties, as a potential dosage form for paediatric and geriatric use employing a slightly soluble model drug-ibuprofen. Different polymers (0.6-10% HPMC, 0.6-1.5% guar gum), plasticisers (0.1-0.5% glycerine, 0.1% sorbitol) and processing conditions (40-60°C drying temperatures, 8-16 h drying times) were investigated to produce films using the solvent casting method. Molecular compatibility was assessed using TGA, XRD and FTIR whereas film topography was assessed using SEM. Maximum ibuprofen load in single films was 20.7 mg/film (54.4%) and released 100% drug content in 5 min, while triple layered ibuprofen-loaded films contained 62.2 mg/film and released 100% drug release in 1 h. The ODFs demonstrated good disintegration time using low volume artificial saliva media and high dosage from uniformity. This study provides a mechanistic insight to the design and evaluation of fast and extended release ODFs with high drug loading, suitable for administration to paediatric and geriatric patients. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/32382992/A_Novel_Technique_to_Improve_Drug_Loading_Capacity_of_Fast/Extended_Release_Orally_Dissolving_Films_with_Potential_for_Paediatric_and_Geriatric_Drug_Delivery_ L2 - https://dx.doi.org/10.1208/s12249-020-01665-5 DB - PRIME DP - Unbound Medicine ER -