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The Formulation and Evaluation of Orally Disintegrating Tablets: Diphenhydramine HCl

Chillas, Stephanie M

Abstract Details

2013, Master of Science in Pharmaceutical Science (MSP), University of Toledo, College of Pharmacy.
Orally disintegrating tablets are a vital tool in keeping our children and elderly population healthy. Their ease of use and accurate dosing allow higher patient compliance and more reliable therapeutic effects. Superdisintegrants are the fundamental element contained in orally disintegrating tablets and are responsible for their unique ability to quickly disintegrate and dissolve on the surface of the tongue without the use of any additional liquid. In order to determine the most effective type and optimal amount of superdisintegrants for orally disintegrating tablets manufactured by direct compression, the following tablet parameters were tested (based on the standard USP 30 methods): hardness, thickness, friability, disintegration time, and wetting time. Four superdisintegrants were tested, namely: Kollidon CL-SF®, Primojel®, Ac-Di-Sol®, and Polyplasdone XL®, and the most efficient superdisintegrant was selected based on the above mentioned studies. Polyplasdone XL® outperformed the other superdisintegrants in nearly all the concentrations and all of the testing parameters. The ideal concentration was 5% Polyplasdone XL® for the orally disintegrating tablets before the API, diphenhydramine HCl, was added. Various concentrations were analyzed using the aforementioned parameters and 10% Polyplasdone XL® was selected for the final formulation. Tablets were tested over eight weeks of accelerated stability testing at various temperatures to determine percent of diphenhydramine HCl released in dissolution, disintegration time, wetting time, hardness, thickness, and weight variation. The tablets remained stable and within the acceptable range of drug release (90%-110%) at the three temperatures analyzed. Additionally, tablets were analyzed at different levels of relative humidity for percent weight change and change in hardness. The final formulation of diphenhydramine HCl tablets was stable between 3-40°C and at 33% relative humidity or less for eight weeks.
Kenneth Alexander, PhD (Committee Chair)
Sai Hanuman Sagar Boddu, PhD (Committee Member)
Caren Steinmiller, PhD (Committee Member)
171 p.

Recommended Citations

Citations

  • Chillas, S. M. (2013). The Formulation and Evaluation of Orally Disintegrating Tablets: Diphenhydramine HCl [Master's thesis, University of Toledo]. OhioLINK Electronic Theses and Dissertations Center. http://rave.ohiolink.edu/etdc/view?acc_num=mco1371774622

    APA Style (7th edition)

  • Chillas, Stephanie. The Formulation and Evaluation of Orally Disintegrating Tablets: Diphenhydramine HCl. 2013. University of Toledo, Master's thesis. OhioLINK Electronic Theses and Dissertations Center, http://rave.ohiolink.edu/etdc/view?acc_num=mco1371774622.

    MLA Style (8th edition)

  • Chillas, Stephanie. "The Formulation and Evaluation of Orally Disintegrating Tablets: Diphenhydramine HCl." Master's thesis, University of Toledo, 2013. http://rave.ohiolink.edu/etdc/view?acc_num=mco1371774622

    Chicago Manual of Style (17th edition)