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An in vitro analysis of disintegration times of different formulations of olanzapine orodispersible tablet: a preliminary report.
Drugs R D. 2013 Dec; 13(4):281-8.DR

Abstract

BACKGROUND

Orodispersible tablets (ODTs) are tablet or wafer forms of medication that disintegrate in the mouth, aided only by saliva. ODTs rely on different fast dissolve/disintegration manufacturing technologies.

OBJECTIVES

Disintegration time differences for several olanzapine ODT forms were investigated. Risperdal M-Tab(®) was included as a non-olanzapine ODT comparator.

RESEARCH DESIGN AND METHODS

Eleven olanzapine ODT examples and orodispersible risperidone strengths were evaluated in vitro for formulation composition, manufacturing method, disintegration and dissolution characteristics, and formulation differences in comparison with freeze dried Zydis(®) ODT. Automated dissolution test equipment captured ODT dissolution rates by measuring real-time release of active ingredient. A high-speed video camera was used to capture tablet disintegration times in warm simulated saliva.

MAIN OUTCOME MEASURE

The main outcome measure was the disintegration and dissolution characteristics of the ODT formulations.

RESULTS

The ODT manufacturing method was associated with time to disintegrate; the fastest were freeze dried tablets, followed by soft compressed tablets and then hard/dense tablets. Olanzapine Zydis(®) was the only ODT that completely disintegrated in less than 4 s for all strengths (5, 10, 15, and 20 mg), followed by 5-mg Prolanz FAST(®) (12 s) and then risperidone ODT 4 mg (40 s). Reasons for slow dissolution of the olanzapine generics may include low product potency, excipient binding, excipient solubility, active ingredient particle size and incomplete disintegration.

CONCLUSIONS

Differences in the formulation and manufacturing process of olanzapine ODTs appear to have a strong influence on the disintegration time of the active compound; differences that may potentially impact their use in clinical practice.

Authors+Show Affiliations

Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA, hobbsdg@lilly.com.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24170256

Citation

Hobbs, David, et al. "An in Vitro Analysis of Disintegration Times of Different Formulations of Olanzapine Orodispersible Tablet: a Preliminary Report." Drugs in R&D, vol. 13, no. 4, 2013, pp. 281-8.
Hobbs D, Karagianis J, Treuer T, et al. An in vitro analysis of disintegration times of different formulations of olanzapine orodispersible tablet: a preliminary report. Drugs R D. 2013;13(4):281-8.
Hobbs, D., Karagianis, J., Treuer, T., & Raskin, J. (2013). An in vitro analysis of disintegration times of different formulations of olanzapine orodispersible tablet: a preliminary report. Drugs in R&D, 13(4), 281-8. https://doi.org/10.1007/s40268-013-0030-8
Hobbs D, et al. An in Vitro Analysis of Disintegration Times of Different Formulations of Olanzapine Orodispersible Tablet: a Preliminary Report. Drugs R D. 2013;13(4):281-8. PubMed PMID: 24170256.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An in vitro analysis of disintegration times of different formulations of olanzapine orodispersible tablet: a preliminary report. AU - Hobbs,David, AU - Karagianis,Jamie, AU - Treuer,Tamas, AU - Raskin,Joel, PY - 2013/10/31/entrez PY - 2013/10/31/pubmed PY - 2014/9/24/medline SP - 281 EP - 8 JF - Drugs in R&D JO - Drugs R D VL - 13 IS - 4 N2 - BACKGROUND: Orodispersible tablets (ODTs) are tablet or wafer forms of medication that disintegrate in the mouth, aided only by saliva. ODTs rely on different fast dissolve/disintegration manufacturing technologies. OBJECTIVES: Disintegration time differences for several olanzapine ODT forms were investigated. Risperdal M-Tab(®) was included as a non-olanzapine ODT comparator. RESEARCH DESIGN AND METHODS: Eleven olanzapine ODT examples and orodispersible risperidone strengths were evaluated in vitro for formulation composition, manufacturing method, disintegration and dissolution characteristics, and formulation differences in comparison with freeze dried Zydis(®) ODT. Automated dissolution test equipment captured ODT dissolution rates by measuring real-time release of active ingredient. A high-speed video camera was used to capture tablet disintegration times in warm simulated saliva. MAIN OUTCOME MEASURE: The main outcome measure was the disintegration and dissolution characteristics of the ODT formulations. RESULTS: The ODT manufacturing method was associated with time to disintegrate; the fastest were freeze dried tablets, followed by soft compressed tablets and then hard/dense tablets. Olanzapine Zydis(®) was the only ODT that completely disintegrated in less than 4 s for all strengths (5, 10, 15, and 20 mg), followed by 5-mg Prolanz FAST(®) (12 s) and then risperidone ODT 4 mg (40 s). Reasons for slow dissolution of the olanzapine generics may include low product potency, excipient binding, excipient solubility, active ingredient particle size and incomplete disintegration. CONCLUSIONS: Differences in the formulation and manufacturing process of olanzapine ODTs appear to have a strong influence on the disintegration time of the active compound; differences that may potentially impact their use in clinical practice. SN - 1179-6901 UR - https://www.unboundmedicine.com/medline/citation/24170256/An_in_vitro_analysis_of_disintegration_times_of_different_formulations_of_olanzapine_orodispersible_tablet:_a_preliminary_report_ L2 - https://dx.doi.org/10.1007/s40268-013-0030-8 DB - PRIME DP - Unbound Medicine ER -