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Formulation studies for mirtazapine orally disintegrating tablets.
Drug Dev Ind Pharm. 2016; 42(6):1008-17.DD

Abstract

OBJECTIVE

Orally disintegrating tablets (ODTs) recently have gained much attention to fulfill the needs for pediatric, geriatric, and psychiatric patients with dysphagia. Aim of this study was to develop new ODT formulations containing mirtazapine, an antidepressant drug molecule having bitter taste, by using simple and inexpensive preparation methods such as coacervation, direct compression and to compare their characteristics with those of reference product (Remereon SolTab).

MATERIALS AND METHODS

Coacervation method was chosen for taste masking of mirtazapine. In vitro characterization studies such as diameter and thickness, weight variation, tablet hardness, tablet friability and disintegration time were performed on tablet formulations. Wetting time and in vitro dissolution tests of developed ODTs also studied using 900 mL 0.1 N HCl medium, 900 mL pH 6.8 phosphate buffer or 900 mL pH 4.5 acetate buffer at 37 ± 0.2 °C as dissolution medium.

RESULTS

Ratio of Eudragit® E-100 was chosen as 6% (w/w) since the dissolution profile of A1 (6% Eudragit® E-100) was found closer to the reference product than A2 (4% Eudragit® E-100) and A3 (8% Eudragit® E-100). Group D, E and F formulations were presented better results in terms of disintegration time. Dissolution results indicated that Group E and F formulations showed optimum properties in all three dissolution media.

DISCUSSION

Formulations D1, D4, D5, E3, E4, F1 and F5 found suitable as ODT formulations due to their favorable disintegration times and dissolution profiles.

CONCLUSION

Developed mirtazapine ODTs were found promising in terms of showing the similar characteristics to the original formulation.

Authors+Show Affiliations

a Department of Pharmaceutical Technology , Hacettepe University, Faculty of Pharmacy , Ankara , Turkey.a Department of Pharmaceutical Technology , Hacettepe University, Faculty of Pharmacy , Ankara , Turkey.a Department of Pharmaceutical Technology , Hacettepe University, Faculty of Pharmacy , Ankara , Turkey.a Department of Pharmaceutical Technology , Hacettepe University, Faculty of Pharmacy , Ankara , Turkey.a Department of Pharmaceutical Technology , Hacettepe University, Faculty of Pharmacy , Ankara , Turkey.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

26530146

Citation

Yıldız, Simay, et al. "Formulation Studies for Mirtazapine Orally Disintegrating Tablets." Drug Development and Industrial Pharmacy, vol. 42, no. 6, 2016, pp. 1008-17.
Yıldız S, Aytekin E, Yavuz B, et al. Formulation studies for mirtazapine orally disintegrating tablets. Drug Dev Ind Pharm. 2016;42(6):1008-17.
Yıldız, S., Aytekin, E., Yavuz, B., Bozdağ Pehlivan, S., & Ünlü, N. (2016). Formulation studies for mirtazapine orally disintegrating tablets. Drug Development and Industrial Pharmacy, 42(6), 1008-17. https://doi.org/10.3109/03639045.2015.1104345
Yıldız S, et al. Formulation Studies for Mirtazapine Orally Disintegrating Tablets. Drug Dev Ind Pharm. 2016;42(6):1008-17. PubMed PMID: 26530146.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Formulation studies for mirtazapine orally disintegrating tablets. AU - Yıldız,Simay, AU - Aytekin,Eren, AU - Yavuz,Burçin, AU - Bozdağ Pehlivan,Sibel, AU - Ünlü,Nurşen, Y1 - 2015/11/04/ PY - 2015/11/5/entrez PY - 2015/11/5/pubmed PY - 2016/12/28/medline KW - Formulation development KW - microencapsulation KW - mirtazapine KW - orally disintegrating tablets KW - taste masking SP - 1008 EP - 17 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 42 IS - 6 N2 - OBJECTIVE: Orally disintegrating tablets (ODTs) recently have gained much attention to fulfill the needs for pediatric, geriatric, and psychiatric patients with dysphagia. Aim of this study was to develop new ODT formulations containing mirtazapine, an antidepressant drug molecule having bitter taste, by using simple and inexpensive preparation methods such as coacervation, direct compression and to compare their characteristics with those of reference product (Remereon SolTab). MATERIALS AND METHODS: Coacervation method was chosen for taste masking of mirtazapine. In vitro characterization studies such as diameter and thickness, weight variation, tablet hardness, tablet friability and disintegration time were performed on tablet formulations. Wetting time and in vitro dissolution tests of developed ODTs also studied using 900 mL 0.1 N HCl medium, 900 mL pH 6.8 phosphate buffer or 900 mL pH 4.5 acetate buffer at 37 ± 0.2 °C as dissolution medium. RESULTS: Ratio of Eudragit® E-100 was chosen as 6% (w/w) since the dissolution profile of A1 (6% Eudragit® E-100) was found closer to the reference product than A2 (4% Eudragit® E-100) and A3 (8% Eudragit® E-100). Group D, E and F formulations were presented better results in terms of disintegration time. Dissolution results indicated that Group E and F formulations showed optimum properties in all three dissolution media. DISCUSSION: Formulations D1, D4, D5, E3, E4, F1 and F5 found suitable as ODT formulations due to their favorable disintegration times and dissolution profiles. CONCLUSION: Developed mirtazapine ODTs were found promising in terms of showing the similar characteristics to the original formulation. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/26530146/Formulation_studies_for_mirtazapine_orally_disintegrating_tablets_ L2 - https://www.tandfonline.com/doi/full/10.3109/03639045.2015.1104345 DB - PRIME DP - Unbound Medicine ER -