SINGLE LAYER EXTENDED RELEASE TWO-IN-ONE GUAIFENESIN MATRIX TABLET: FORMULATION METHOD, OPTIMIZATION, RELEASE KINETICS EVALUATION AND ITS COMPARISON WITH MUCINEX® USING BOX- BEHNKEN DESIGN

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MOROVATI AMIRHOSEIN; GHAFFARI ALIREZA; ERFANI JABARIAN LALEH; Mehramizi Ali

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Journal Paper

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Journal: Iranian Journal of Pharmaceutical Research Year:2017 | Volume:16 | Issue:4 Page(s): 1349-1369

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Title

SINGLE LAYER EXTENDED RELEASE TWO-IN-ONE GUAIFENESIN MATRIX TABLET: FORMULATION METHOD, OPTIMIZATION, RELEASE KINETICS EVALUATION AND ITS COMPARISON WITH MUCINEX® USING BOX- BEHNKEN DESIGN

Author(s)

MOROVATI AMIRHOSEIN | GHAFFARI ALIREZA | ERFANI JABARIAN LALEH | Mehramizi Ali | Issue Writer Certificate

Keywords

BINARY MIXTURE

BILAYER TABLETS

HIGH DOSE MODIFIED RELEASE TABLETS

HIGHLY WATER- SOLUBLE DRUG

POOR COMPRESSIBILITY

Abstract

Guaifenesin, a highly water- soluble active (50 mg/mL), classified as a BCS class I drug. Owing to its poor flowability and compressibility, formulating tablets especially high-dose one, may be a challenge. Direct compression may not be feasible. Bilayer tablet technology applied to MucinexÒ, endures challenges to deliver a robust formulation. To overcome challenges involved in bilayer- tablet manufacturing and powder compressibility, an optimized single layer tablet prepared by a BINARY MIXTURE (Two-in-one), mimicking the dual drug release character of MucinexÒ was purposed.A 3-factor, 3-level Box- Behnken design was applied to optimize seven considered dependent variables (Release "%" in 1, 2, 4, 6, 8, 10 and 12 h) regarding different levels of independent one (X1: Cetyl alcohol, X2: Starch 1500Ò, X3: HPMC K100M amounts). Two granule portions were prepared using melt and wet granulations, blended together prior to compression. An optimum formulation was obtained (X1: 37.10, X2: 2, X3: 42.49 mg). Desirability function was 0.616. F2 and f1 between release profiles of MucinexÒ and the optimum formulation were 74 and 3, respectively. An n-value of about 0.5 for both optimum and MucinexÒ formulations showed diffusion (Fickian) control mechanism. However, HPMC K100M rise in 70 mg accompanied cetyl alcohol rise in 60 mg led to first order kinetic (n=0.6962). The K values of 1.56 represented an identical burst drug releases. Cetyl alcohol and starch 1500Ò modulated guaifenesin release from HPMC K100M matrices, while due to their binding properties, improved its poor flowability and compressibility, too.

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APA: Copy

MOROVATI, AMIRHOSEIN, GHAFFARI, ALIREZA, ERFANI JABARIAN, LALEH, & Mehramizi, Ali. (2017). SINGLE LAYER EXTENDED RELEASE TWO-IN-ONE GUAIFENESIN MATRIX TABLET: FORMULATION METHOD, OPTIMIZATION, RELEASE KINETICS EVALUATION AND ITS COMPARISON WITH MUCINEX® USING BOX- BEHNKEN DESIGN. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), 16(4), 1349-1369. SID. https://sid.ir/paper/288739/en

Vancouver: Copy

MOROVATI AMIRHOSEIN, GHAFFARI ALIREZA, ERFANI JABARIAN LALEH, Mehramizi Ali. SINGLE LAYER EXTENDED RELEASE TWO-IN-ONE GUAIFENESIN MATRIX TABLET: FORMULATION METHOD, OPTIMIZATION, RELEASE KINETICS EVALUATION AND ITS COMPARISON WITH MUCINEX® USING BOX- BEHNKEN DESIGN. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR)[Internet]. 2017;16(4):1349-1369. Available from: https://sid.ir/paper/288739/en

IEEE: Copy

AMIRHOSEIN MOROVATI, ALIREZA GHAFFARI, LALEH ERFANI JABARIAN, and Ali Mehramizi, “SINGLE LAYER EXTENDED RELEASE TWO-IN-ONE GUAIFENESIN MATRIX TABLET: FORMULATION METHOD, OPTIMIZATION, RELEASE KINETICS EVALUATION AND ITS COMPARISON WITH MUCINEX® USING BOX- BEHNKEN DESIGN,” IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), vol. 16, no. 4, pp. 1349–1369, 2017, [Online]. Available: https://sid.ir/paper/288739/en

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