Feasibility of mini-tablets as a flexible drug delivery tool

[Display omitted] Mini-tablets have potential applications as a flexible drug delivery tool in addition to their generally perceived use as multi-particulates. That is, mini-tablets could provide flexibility in dose finding studies and/or allow for combination therapies in the clinic. Moreover, mini...

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Bibliographic Details
Published in:International journal of pharmaceutics 2017-06, Vol.525 (1), p.149-159
Main Authors: Mitra, Biplob, Chang, Jessica, Wu, Sy-Juen, Wolfe, Chad N., Ternik, Robert L., Gunter, Thomas Z., Victor, Michael C.
Format: Article
Language:English
Subjects:
Chemistry, Pharmaceutical
Content uniformity
Dose flexibility
Drug Compounding
Drug Delivery Systems
Drug delivery tool
Fixed dose combination
Humans
Mini-tablets
Orally disintegrating mini-tablets
Physico-mechanical attributes
Solubility
Tablets
Tensile Strength
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Summary:[Display omitted] Mini-tablets have potential applications as a flexible drug delivery tool in addition to their generally perceived use as multi-particulates. That is, mini-tablets could provide flexibility in dose finding studies and/or allow for combination therapies in the clinic. Moreover, mini-tablets with well controlled quality attributes could be a prudent choice for administering solid dosage forms as a single unit or composite of multiple mini-tablets in patient populations with swallowing difficulties (e.g., pediatric and geriatric populations). This work demonstrated drug substance particle size and concentration ranges that achieve acceptable mini-tablet quality attributes for use as a single or composite dosage unit. Immediate release and orally disintegrating mini-tablet formulations with 30μm to 350μm (particle size d90) acetaminophen and Compap™ L (90% acetaminophen) at concentrations equivalent to 6.7% and 26.7% acetaminophen were evaluated. Mini-tablets achieved acceptable weight variability, tensile strength, friability, and disintegration time at a reasonable solid fraction for each formulation. The content uniformity was acceptable for mini-tablets of 6.7% formulations with ≤170μm drug substance, mini-tablets of all 26.7% formulations, and composite dosage units containing five or more mini-tablets of any formulation. Results supported the manufacturing feasibility of quality mini-tablets, and their applicability as a flexible drug delivery tool.
ISSN:0378-5173
1873-3476
DOI:10.1016/j.ijpharm.2017.04.037