AAPS PharmSciTech

, Volume 19, Issue 3, pp 1358–1366 | Cite as

Micronized Zaleplon Delivery via Orodispersible Film and Orodispersible Tablets

  • Prashanth Manda
  • Carmen Popescu
  • Abhishek Juluri
  • Karthik Janga
  • Praneeth Rao Kakulamarri
  • Sushmitha Narishetty
  • S. Narasimha Murthy
  • Michael A. Repka
Research Article


The following research study focuses on improving the solubility of zaleplon (BCS class II drug) via micronization technique in order to enhance its oral delivery in orodispersible formulations. Zaleplon along with a surfactant solution was micronized by ultrasonication. The micronization process reduced the particle size of the crystalline drug about six-fold from its original size of 155.5 μm. The micronized zalepon dispersion was lyophilized to allow for a change in the state of matter (to a powder). The superior dissolution parameters (Q5, Q30, IDR, MDR, MDT, DE, and RDR) of zaleplon in microcrystalline form over the original crystalline form in in vitro dissolution studies had unraveled that micronization technique is an efficient tool in enhancing drug solubility. The micronized zaleplon solid dispersion (after lyophilization) was loaded into orodispersible tablet (ODT) and orodispersible film (ODF) formulations. The positive quality of ODT with adequate hardness and smooth texture was attributing to the presence of Pearlitol Flash® as a ready to use ODT platform. On the other hand, the ODF loaded with micronized zaleplon and prepared with Lycoat® RS 720 (as a film former) ensured adequate tensile strength. The disintegration time of ODT and ODF was 30 ± 5 and 35 ± 5 s, respectively. Thus, the orodispersible formulations containing micronized zaleplon have a strong potential for rapid disintegration following superior absorption in solution state through oral cavity into the blood stream, envisaging better oral delivery.


Micronization Zaleplon Lyophilization Orodispersible films Orodispersible tablet Lycoat® RS 720 Neosorb® P60W Pearlitol Flash® 



biopharmaceutics classification system


cumulative drug release in 5 min


cumulative drug release in 30 min


dissolution efficiency


mean dissolution time (minutes)


mean dissolution rate


initial dissolution rate


relative dissolution rate to pure drug


micronized zaleplon lyophilized powder


Fourier transform infrared


powder X-ray diffractometry


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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  • Prashanth Manda
    • 1
    • 2
  • Carmen Popescu
    • 2
  • Abhishek Juluri
    • 1
  • Karthik Janga
    • 3
  • Praneeth Rao Kakulamarri
    • 4
  • Sushmitha Narishetty
    • 5
  • S. Narasimha Murthy
    • 1
  • Michael A. Repka
    • 1
  1. 1.Department of Pharmaceutics and Drug DeliveryThe University of Mississippi, UniversityOxfordUSA
  2. 2.Roquette America Inc.GenevaUSA
  3. 3.Kakatiya Institute of Pharmaceutical SciencesWarangalIndia
  4. 4.Ascent Pharmaceuticals, Centre IslipNew YorkUSA
  5. 5.Kalamazoo CollegeKalamazooUSA

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