Tags

Type your tag names separated by a space and hit enter

Evaluation of Chlorpheniramine Maleate microparticles in orally disintegrating film and orally disintegrating tablet for pediatrics.
Drug Dev Ind Pharm. 2014 Jul; 40(7):910-8.DD

Abstract

OBJECTIVE

To mask the bitterness of Chlorpheniramine Maleate via encapsulating drug into Eudragit EPO microparticles, and then incorporate these microparticles into orally disintegrating films (ODF) and orally disintegrating tablets (ODT) for pediatric uses.

METHODS

Spray drying of water-in-oil emulsion was utilized to encapsulate Chlorpheniramine Maleate into Eudragit EPO microparticles. Based on an orthogonal experimental design L9 (3(3)), polynomial regression models were developed to evaluate correlation between microparticle properties (encapsulation efficiency and drug release) and variables (X1: weight ratio of polymer to drug, X2: volume ratio of oil to water and X3: Q-flow of spray dryer). ODF and ODT formulations were evaluated including weight variation, content uniformity, tensile strength, disintegration time, friability and dissolution profiles. The bitterness taste test was evaluated in 10 adult volunteers.

RESULTS AND DISCUSSION

From polynomial regression analysis, the best values of variables leading to the optimized microparticles were X1 = 10, X2 = 3 and X3 = 45. The optimized microparticles were incorporated into ODF and ODT with satisfactory weight and drug content uniformity, and acceptable physical strength. Both dosage forms disintegrated immediately (less than 40 s) in simulated saliva solutions. The outcome of taste-masking test indicated that microparticles alleviated drug bitterness significantly; bitterness was not discernible with microparticles incorporated in ODT, whereas only slight bitterness was detected from microparticles incorporated into ODF.

CONCLUSION

Both ODF and ODT are shown to be suitable vehicles for taste masked Chlorpheniramine Maleate microparticles with potential for pediatric uses.

Authors+Show Affiliations

Department of Pharmaceutical Sciences, University of Tennessee Health Science Center , Memphis, TN , USA .No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

23621768

Citation

Lou, Hao, et al. "Evaluation of Chlorpheniramine Maleate Microparticles in Orally Disintegrating Film and Orally Disintegrating Tablet for Pediatrics." Drug Development and Industrial Pharmacy, vol. 40, no. 7, 2014, pp. 910-8.
Lou H, Liu M, Qu W, et al. Evaluation of Chlorpheniramine Maleate microparticles in orally disintegrating film and orally disintegrating tablet for pediatrics. Drug Dev Ind Pharm. 2014;40(7):910-8.
Lou, H., Liu, M., Qu, W., Hu, Z., Brunson, E., Johnson, J., & Almoazen, H. (2014). Evaluation of Chlorpheniramine Maleate microparticles in orally disintegrating film and orally disintegrating tablet for pediatrics. Drug Development and Industrial Pharmacy, 40(7), 910-8. https://doi.org/10.3109/03639045.2013.789907
Lou H, et al. Evaluation of Chlorpheniramine Maleate Microparticles in Orally Disintegrating Film and Orally Disintegrating Tablet for Pediatrics. Drug Dev Ind Pharm. 2014;40(7):910-8. PubMed PMID: 23621768.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of Chlorpheniramine Maleate microparticles in orally disintegrating film and orally disintegrating tablet for pediatrics. AU - Lou,Hao, AU - Liu,Min, AU - Qu,Wen, AU - Hu,Zheyi, AU - Brunson,Ed, AU - Johnson,James, AU - Almoazen,Hassan, Y1 - 2013/04/26/ PY - 2013/4/30/entrez PY - 2013/4/30/pubmed PY - 2015/1/27/medline KW - Design of experiment KW - microparticle KW - orally disintegrating film KW - orally disintegrating tablet KW - taste masking SP - 910 EP - 8 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 40 IS - 7 N2 - OBJECTIVE: To mask the bitterness of Chlorpheniramine Maleate via encapsulating drug into Eudragit EPO microparticles, and then incorporate these microparticles into orally disintegrating films (ODF) and orally disintegrating tablets (ODT) for pediatric uses. METHODS: Spray drying of water-in-oil emulsion was utilized to encapsulate Chlorpheniramine Maleate into Eudragit EPO microparticles. Based on an orthogonal experimental design L9 (3(3)), polynomial regression models were developed to evaluate correlation between microparticle properties (encapsulation efficiency and drug release) and variables (X1: weight ratio of polymer to drug, X2: volume ratio of oil to water and X3: Q-flow of spray dryer). ODF and ODT formulations were evaluated including weight variation, content uniformity, tensile strength, disintegration time, friability and dissolution profiles. The bitterness taste test was evaluated in 10 adult volunteers. RESULTS AND DISCUSSION: From polynomial regression analysis, the best values of variables leading to the optimized microparticles were X1 = 10, X2 = 3 and X3 = 45. The optimized microparticles were incorporated into ODF and ODT with satisfactory weight and drug content uniformity, and acceptable physical strength. Both dosage forms disintegrated immediately (less than 40 s) in simulated saliva solutions. The outcome of taste-masking test indicated that microparticles alleviated drug bitterness significantly; bitterness was not discernible with microparticles incorporated in ODT, whereas only slight bitterness was detected from microparticles incorporated into ODF. CONCLUSION: Both ODF and ODT are shown to be suitable vehicles for taste masked Chlorpheniramine Maleate microparticles with potential for pediatric uses. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/23621768/Evaluation_of_Chlorpheniramine_Maleate_microparticles_in_orally_disintegrating_film_and_orally_disintegrating_tablet_for_pediatrics_ L2 - http://www.tandfonline.com/doi/full/10.3109/03639045.2013.789907 DB - PRIME DP - Unbound Medicine ER -