PEARLITOL® Flash | Mannitol-starch compound
The Science Behind

PEARLITOL® Flash | Mannitol-starch compound

Peer-reviewed journal articles and scientific presentations describing use of PEARLITOL® Flash mannitol, starch

Study 1

Micronized zaleplon delivery via orodispersible film and orodispersible tablets

Manda P, Popescu C, Juluri A, Janga K, Kakulamarri PR, Narishetty S, Murthy SN, Repka MA.

AAPS PharmSciTech. 2018 Apr 1;19(3):1358-66.
https://doi.org/10.1208/s12249-017-0924-9
Publisher: Springer US
© American Association of Pharmaceutical Scientists 2018

Abstract

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 zaleplon 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 bloodstream, envisaging better oral delivery.

Study 2

Application of Quality by Design Principles to Study the Effect of Coprocessed Materials in the Preparation of Mirtazapine Orodispersible Tablets

Darwish MK.

International Journal of Drug Delivery. 2013 Jul 1;5(3):309.
https://www.arjournals.org/index.php/ijdd/article/view/1199
Publisher: AR Journals
© The Authors

Abstract

The aim of this study was to determine the effect of two coprocessed materials in presence and absence of superdisintegrant (kyron T314) in the preparation of mirtazapine orodispersible tablets. Mirtazapine solubility was increased by complexation with KLEPTOSE® beta-cyclodextrin forming an inclusion complex in a ratio 1:1. Quality by Design (QbD) was incorporated to determine the material attributes and the critical quality attributes (CQAs). Box-Behnken design was applied to study the effect of three independent variables X1: amount of Ludiflash®*, X2: amount of PEARLITOL® Flash and X3: % of kyron T314 on two responses, Y1: dissolution after 1 minute and Y2: disintegration time. All formulated ODTs showed disintegration time less than 35 seconds, and all formulations showed a notable increase in dissolution rate. Design space was determined from the overlay plot of different variables, X1 and X2 and X3 at two levels of the superdisintegrant. The one with maximum predicted dissolution rate and minimum predicted disintegration time was a formulation containing Ludiflash® (X1)= 9.25 mg, PEARLITOL® Flash (X2= 50 mg) and kyron T314= 3%. This formulation (Test ODT) was prepared and was subjected to in vivo study. Mirtazapine in human plasma was determined by LC-MS/MS and different pharmacokinetic parameters was determined for both test ODT and conventional oral tablet (Remeron). The pharmacokinetic parameters indicated that the two formulations are bioequivalence.

*Ludiflash® is registered trademark of BASF

Study 3

The application of factor analysis to evaluate deforming behaviors of directly compressed powders

 Li XH, Zhao LJ, Ruan KP, Feng Y, Ruan KF.

Powder technology. 2013 Oct 1;247:47-54.
https://doi.org/10.1016/j.powtec.2013.06.040
Publisher: Elsevier B.V.
© The Authors

Abstract

In this study, we present an approach that describes plasticity and deformation behavior of well-known materials based on analysis of plasticity, elasticity and fragmentary behavior. The powders were compressed using Korsch XP1, and the correlations between compaction and physical parameters were analyzed by canonical correlation analysis (CCA). Factor analysis (FA) was employed to normalize compaction work, yield pressure measurements (YP) and determine elastic stretch for all our sample; these were scored and ranked accordingly. The canonical variables showed that true density (ρa), compression degree (Cp) and mean particle size (D50) were associated with plastic coefficient (PL), YP, and fast elastic stretch (FES). When factor scores were used in combination with original data, the plasticity of our samples was sorted and ranked as high, intermediate, or low, which are in accord with plasticity rankings previously reported in literature. Hence, physical and compaction data interval was established that evaluated powder deformation behavior during compaction. Finally, FA was used to further characterize deformation behavior during compaction.