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Treatment of Radiation-Induced Oral Mucositis Using a Novel Accepted Taste of Prolonged Release Mucoadhesive Bi-medicated Double-Layer Buccal Films
The aim of this study was to develop a novel double-layer bi-medicated prolonged release mucoadhesive buccal film (MBF) containing lidocaine hydrochloride (LC) and diclofenac potassium (DK). The ultimate goal of the prepared system is the treatment of radiation-induced oral mucositis pain with impro...
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Published in: | AAPS PharmSciTech 2017-02, Vol.18 (2), p.563-575 |
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creator | Abo Enin, Hadel A. El Nabarawy, Nagla Ahmed Elmonem, Rehab A. Abd |
description | The aim of this study was to develop a novel double-layer bi-medicated prolonged release mucoadhesive buccal film (MBF) containing lidocaine hydrochloride (LC) and diclofenac potassium (DK). The ultimate goal of the prepared system is the treatment of radiation-induced oral mucositis pain with improved patient acceptance. MBFs were prepared using 3 × 2
2
randomized full factorial design for film optimization. Nanoemulsion system (NES) was used to mask DK bitter taste. The prepared films were characterized, viz thickness, mass uniformity, surface pH, folding endurance, swelling studies,
ex vivo
bioadhesive strength,
in vitro
drug release, and
ex vivo
permeation. The
in vivo
evaluation was carried out by testing the anti-inflammatory and analgesic activities on rats followed by a clinical study on patients to prove their acceptance. The optimized MBF composed of 10%
w
/
w
HPMC-4KM, 50 mg LC, and 50 mg DK-NES was selected due to prolonged
in vitro
drug release pattern and
ex vivo
permeability (95.24 ± 2.14 and 93.48 ± 3.24% in 6 h, respectively). MBF exposed a strong anti-inflammatory effect from 61 to 87% inhibition with a strong analgesic effect when compared to DK® and LC®, respectively. The clinical study revealed that films were accepted by the patients, and the presence of LC on the outer side helped in pain feeling reduction while DK-NES in the inner side facilitated in rapidly relieving the inflammation effect. |
doi_str_mv | 10.1208/s12249-016-0533-z |
format | article |
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2
randomized full factorial design for film optimization. Nanoemulsion system (NES) was used to mask DK bitter taste. The prepared films were characterized, viz thickness, mass uniformity, surface pH, folding endurance, swelling studies,
ex vivo
bioadhesive strength,
in vitro
drug release, and
ex vivo
permeation. The
in vivo
evaluation was carried out by testing the anti-inflammatory and analgesic activities on rats followed by a clinical study on patients to prove their acceptance. The optimized MBF composed of 10%
w
/
w
HPMC-4KM, 50 mg LC, and 50 mg DK-NES was selected due to prolonged
in vitro
drug release pattern and
ex vivo
permeability (95.24 ± 2.14 and 93.48 ± 3.24% in 6 h, respectively). MBF exposed a strong anti-inflammatory effect from 61 to 87% inhibition with a strong analgesic effect when compared to DK® and LC®, respectively. The clinical study revealed that films were accepted by the patients, and the presence of LC on the outer side helped in pain feeling reduction while DK-NES in the inner side facilitated in rapidly relieving the inflammation effect.</description><identifier>ISSN: 1530-9932</identifier><identifier>EISSN: 1530-9932</identifier><identifier>DOI: 10.1208/s12249-016-0533-z</identifier><identifier>PMID: 27138037</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adhesiveness ; Adhesives - administration & dosage ; Adhesives - chemistry ; Administration, Buccal ; Adult ; Analgesics - administration & dosage ; Analgesics - chemistry ; Animals ; Anti-Inflammatory Agents - administration & dosage ; Anti-Inflammatory Agents - chemistry ; Biochemistry ; Biomedical and Life Sciences ; Biomedicine ; Biotechnology ; Delayed-Action Preparations - administration & dosage ; Delayed-Action Preparations - chemistry ; Diclofenac - chemistry ; Drug Delivery Systems - methods ; Drug Liberation ; Female ; Humans ; Lidocaine - chemistry ; Male ; Middle Aged ; Mouth Mucosa - drug effects ; Permeability ; Pharmacology/Toxicology ; Pharmacy ; Research Article ; Sheep ; Stomatitis - drug therapy ; Taste ; Young Adult</subject><ispartof>AAPS PharmSciTech, 2017-02, Vol.18 (2), p.563-575</ispartof><rights>American Association of Pharmaceutical Scientists 2016</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c344t-3a58528caab275e5223c9576020dba3ef136332ce979a9b95ad5214a9d3a2893</citedby><cites>FETCH-LOGICAL-c344t-3a58528caab275e5223c9576020dba3ef136332ce979a9b95ad5214a9d3a2893</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27138037$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Abo Enin, Hadel A.</creatorcontrib><creatorcontrib>El Nabarawy, Nagla Ahmed</creatorcontrib><creatorcontrib>Elmonem, Rehab A. Abd</creatorcontrib><title>Treatment of Radiation-Induced Oral Mucositis Using a Novel Accepted Taste of Prolonged Release Mucoadhesive Bi-medicated Double-Layer Buccal Films</title><title>AAPS PharmSciTech</title><addtitle>AAPS PharmSciTech</addtitle><addtitle>AAPS PharmSciTech</addtitle><description>The aim of this study was to develop a novel double-layer bi-medicated prolonged release mucoadhesive buccal film (MBF) containing lidocaine hydrochloride (LC) and diclofenac potassium (DK). The ultimate goal of the prepared system is the treatment of radiation-induced oral mucositis pain with improved patient acceptance. MBFs were prepared using 3 × 2
2
randomized full factorial design for film optimization. Nanoemulsion system (NES) was used to mask DK bitter taste. The prepared films were characterized, viz thickness, mass uniformity, surface pH, folding endurance, swelling studies,
ex vivo
bioadhesive strength,
in vitro
drug release, and
ex vivo
permeation. The
in vivo
evaluation was carried out by testing the anti-inflammatory and analgesic activities on rats followed by a clinical study on patients to prove their acceptance. The optimized MBF composed of 10%
w
/
w
HPMC-4KM, 50 mg LC, and 50 mg DK-NES was selected due to prolonged
in vitro
drug release pattern and
ex vivo
permeability (95.24 ± 2.14 and 93.48 ± 3.24% in 6 h, respectively). MBF exposed a strong anti-inflammatory effect from 61 to 87% inhibition with a strong analgesic effect when compared to DK® and LC®, respectively. The clinical study revealed that films were accepted by the patients, and the presence of LC on the outer side helped in pain feeling reduction while DK-NES in the inner side facilitated in rapidly relieving the inflammation effect.</description><subject>Adhesiveness</subject><subject>Adhesives - administration & dosage</subject><subject>Adhesives - chemistry</subject><subject>Administration, Buccal</subject><subject>Adult</subject><subject>Analgesics - administration & dosage</subject><subject>Analgesics - chemistry</subject><subject>Animals</subject><subject>Anti-Inflammatory Agents - administration & dosage</subject><subject>Anti-Inflammatory Agents - chemistry</subject><subject>Biochemistry</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Biotechnology</subject><subject>Delayed-Action Preparations - administration & dosage</subject><subject>Delayed-Action Preparations - chemistry</subject><subject>Diclofenac - chemistry</subject><subject>Drug Delivery Systems - methods</subject><subject>Drug Liberation</subject><subject>Female</subject><subject>Humans</subject><subject>Lidocaine - chemistry</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Mouth Mucosa - drug effects</subject><subject>Permeability</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacy</subject><subject>Research Article</subject><subject>Sheep</subject><subject>Stomatitis - drug therapy</subject><subject>Taste</subject><subject>Young Adult</subject><issn>1530-9932</issn><issn>1530-9932</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><recordid>eNp9kE1OIzEQRi3ECBiGA7BBvoDBdsXp9pJ_kMJkFGXWrWp3BYw67cjuRiLX4MI4E0CsZmXL_t5XqsfYsZKnSsvyLCmtR1ZINRbSAIj1DjtQBqSwFvTut_s--5nSs5QalIU9tq8LBaWE4oC9zSNhv6Su52HBZ9h47H3oxH3XDI4aPo3Y8ofBheR7n_jf5LtHjvx3eKGWnztHqz6n5ph62hT8iaEN3WN-mlFLmOgfi80TJf9C_MKLJTXe4Qa6CkPdkpjgK0V-MTiXJ934dpl-sR8LbBMdfZyHbH5zPb-8E5Pp7f3l-UQ4GI16AWhKo0uHWOvCkNEanDXFWGrZ1Ai0UDAG0I5sYdHW1mBjtBqhbQB1aeGQqW2tiyGlSItqFf0S42ulZLXxW239VtlvtfFbrTNzsmVWQ503-SI-heaA3gZS_soiYvUchtjlNf7T-g6u84fO</recordid><startdate>20170201</startdate><enddate>20170201</enddate><creator>Abo Enin, Hadel A.</creator><creator>El Nabarawy, Nagla Ahmed</creator><creator>Elmonem, Rehab A. Abd</creator><general>Springer US</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20170201</creationdate><title>Treatment of Radiation-Induced Oral Mucositis Using a Novel Accepted Taste of Prolonged Release Mucoadhesive Bi-medicated Double-Layer Buccal Films</title><author>Abo Enin, Hadel A. ; El Nabarawy, Nagla Ahmed ; Elmonem, Rehab A. Abd</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c344t-3a58528caab275e5223c9576020dba3ef136332ce979a9b95ad5214a9d3a2893</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adhesiveness</topic><topic>Adhesives - administration & dosage</topic><topic>Adhesives - chemistry</topic><topic>Administration, Buccal</topic><topic>Adult</topic><topic>Analgesics - administration & dosage</topic><topic>Analgesics - chemistry</topic><topic>Animals</topic><topic>Anti-Inflammatory Agents - administration & dosage</topic><topic>Anti-Inflammatory Agents - chemistry</topic><topic>Biochemistry</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Biotechnology</topic><topic>Delayed-Action Preparations - administration & dosage</topic><topic>Delayed-Action Preparations - chemistry</topic><topic>Diclofenac - chemistry</topic><topic>Drug Delivery Systems - methods</topic><topic>Drug Liberation</topic><topic>Female</topic><topic>Humans</topic><topic>Lidocaine - chemistry</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Mouth Mucosa - drug effects</topic><topic>Permeability</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacy</topic><topic>Research Article</topic><topic>Sheep</topic><topic>Stomatitis - drug therapy</topic><topic>Taste</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Abo Enin, Hadel A.</creatorcontrib><creatorcontrib>El Nabarawy, Nagla Ahmed</creatorcontrib><creatorcontrib>Elmonem, Rehab A. Abd</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>AAPS PharmSciTech</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Abo Enin, Hadel A.</au><au>El Nabarawy, Nagla Ahmed</au><au>Elmonem, Rehab A. Abd</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Treatment of Radiation-Induced Oral Mucositis Using a Novel Accepted Taste of Prolonged Release Mucoadhesive Bi-medicated Double-Layer Buccal Films</atitle><jtitle>AAPS PharmSciTech</jtitle><stitle>AAPS PharmSciTech</stitle><addtitle>AAPS PharmSciTech</addtitle><date>2017-02-01</date><risdate>2017</risdate><volume>18</volume><issue>2</issue><spage>563</spage><epage>575</epage><pages>563-575</pages><issn>1530-9932</issn><eissn>1530-9932</eissn><abstract>The aim of this study was to develop a novel double-layer bi-medicated prolonged release mucoadhesive buccal film (MBF) containing lidocaine hydrochloride (LC) and diclofenac potassium (DK). The ultimate goal of the prepared system is the treatment of radiation-induced oral mucositis pain with improved patient acceptance. MBFs were prepared using 3 × 2
2
randomized full factorial design for film optimization. Nanoemulsion system (NES) was used to mask DK bitter taste. The prepared films were characterized, viz thickness, mass uniformity, surface pH, folding endurance, swelling studies,
ex vivo
bioadhesive strength,
in vitro
drug release, and
ex vivo
permeation. The
in vivo
evaluation was carried out by testing the anti-inflammatory and analgesic activities on rats followed by a clinical study on patients to prove their acceptance. The optimized MBF composed of 10%
w
/
w
HPMC-4KM, 50 mg LC, and 50 mg DK-NES was selected due to prolonged
in vitro
drug release pattern and
ex vivo
permeability (95.24 ± 2.14 and 93.48 ± 3.24% in 6 h, respectively). MBF exposed a strong anti-inflammatory effect from 61 to 87% inhibition with a strong analgesic effect when compared to DK® and LC®, respectively. The clinical study revealed that films were accepted by the patients, and the presence of LC on the outer side helped in pain feeling reduction while DK-NES in the inner side facilitated in rapidly relieving the inflammation effect.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>27138037</pmid><doi>10.1208/s12249-016-0533-z</doi><tpages>13</tpages></addata></record> |
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subjects | Adhesiveness Adhesives - administration & dosage Adhesives - chemistry Administration, Buccal Adult Analgesics - administration & dosage Analgesics - chemistry Animals Anti-Inflammatory Agents - administration & dosage Anti-Inflammatory Agents - chemistry Biochemistry Biomedical and Life Sciences Biomedicine Biotechnology Delayed-Action Preparations - administration & dosage Delayed-Action Preparations - chemistry Diclofenac - chemistry Drug Delivery Systems - methods Drug Liberation Female Humans Lidocaine - chemistry Male Middle Aged Mouth Mucosa - drug effects Permeability Pharmacology/Toxicology Pharmacy Research Article Sheep Stomatitis - drug therapy Taste Young Adult |
title | Treatment of Radiation-Induced Oral Mucositis Using a Novel Accepted Taste of Prolonged Release Mucoadhesive Bi-medicated Double-Layer Buccal Films |
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