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Application of Texture Analysis Technique in Formulation Development of Lyophilized Orally Disintegrating Tablets Containing Mannitol, Polyvinylpyrrolidone and Amino Acids.
AAPS PharmSciTech. 2019 Jan 10; 20(2):71.AP

Abstract

Orally disintegrating tablets (ODTs) attract a great attention as this easy swallowing dosage form often improves patient compliance. In the current work, orally disintegrating tablets comprising mannitol, polyvinylpyrrolidone (PVP) and an amino acid (alanine, glycine or serine) with various PVP-to-amino acid ratios were formulated. The combination of mannitol and an amino acid was aimed to use the advantages of mannitol, the matrix-supporting and disintegration agent, and to reduce the total amount of sugar/polyol in tablets. Tablets were manufactured by freeze-drying and their properties (appearance, internal structure, disintegration, mechanical and texture properties, moisture uptake, shrinkage, thermal properties) were assessed. In the work, great emphasis was placed on illustrating the applicability of the Texture Analysis of the freeze-dried cakes directly in vials in formulation development. The results show that the appearance, mechanical properties, disintegration and shrinkage of the freeze-dried ODTs depend significantly on the excipient composition with PVP playing the leading role. Partial mannitol replacement with an amino acid has a limited impact on the tablet properties. The presence of an amino acid also has no impact on the PVP-mannitol interaction. The mechanical and texture properties of freeze-dried ODTs depend non-linearly on the PVP content. The transition between the different types of textures occurs in a narrow range of PVP concentrations regardless of the type of amino acid in a formulation. The non-linear effect of PVP on various tablet properties should be taken into account when designing ODT formulations as it can compromise the robustness of the manufacturing process.

Authors+Show Affiliations

Leicester School of Pharmacy, Faculty of Health and Life Sciences, De Montfort University, Leicester, UK. School of Pharmacy, University of Reading, Reading, UK.Leicester School of Pharmacy, Faculty of Health and Life Sciences, De Montfort University, Leicester, UK. iermolina@dmu.ac.uk.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30631978

Citation

Hackl, Ellen, and Irina Ermolina. "Application of Texture Analysis Technique in Formulation Development of Lyophilized Orally Disintegrating Tablets Containing Mannitol, Polyvinylpyrrolidone and Amino Acids." AAPS PharmSciTech, vol. 20, no. 2, 2019, p. 71.
Hackl E, Ermolina I. Application of Texture Analysis Technique in Formulation Development of Lyophilized Orally Disintegrating Tablets Containing Mannitol, Polyvinylpyrrolidone and Amino Acids. AAPS PharmSciTech. 2019;20(2):71.
Hackl, E., & Ermolina, I. (2019). Application of Texture Analysis Technique in Formulation Development of Lyophilized Orally Disintegrating Tablets Containing Mannitol, Polyvinylpyrrolidone and Amino Acids. AAPS PharmSciTech, 20(2), 71. https://doi.org/10.1208/s12249-018-1269-8
Hackl E, Ermolina I. Application of Texture Analysis Technique in Formulation Development of Lyophilized Orally Disintegrating Tablets Containing Mannitol, Polyvinylpyrrolidone and Amino Acids. AAPS PharmSciTech. 2019 Jan 10;20(2):71. PubMed PMID: 30631978.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Application of Texture Analysis Technique in Formulation Development of Lyophilized Orally Disintegrating Tablets Containing Mannitol, Polyvinylpyrrolidone and Amino Acids. AU - Hackl,Ellen, AU - Ermolina,Irina, Y1 - 2019/01/10/ PY - 2018/08/16/received PY - 2018/12/05/accepted PY - 2019/1/12/entrez PY - 2019/1/12/pubmed PY - 2019/3/2/medline KW - PVP KW - amino acids KW - freeze-drying KW - orally disintegrating tablets KW - texture analysis SP - 71 EP - 71 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 20 IS - 2 N2 - Orally disintegrating tablets (ODTs) attract a great attention as this easy swallowing dosage form often improves patient compliance. In the current work, orally disintegrating tablets comprising mannitol, polyvinylpyrrolidone (PVP) and an amino acid (alanine, glycine or serine) with various PVP-to-amino acid ratios were formulated. The combination of mannitol and an amino acid was aimed to use the advantages of mannitol, the matrix-supporting and disintegration agent, and to reduce the total amount of sugar/polyol in tablets. Tablets were manufactured by freeze-drying and their properties (appearance, internal structure, disintegration, mechanical and texture properties, moisture uptake, shrinkage, thermal properties) were assessed. In the work, great emphasis was placed on illustrating the applicability of the Texture Analysis of the freeze-dried cakes directly in vials in formulation development. The results show that the appearance, mechanical properties, disintegration and shrinkage of the freeze-dried ODTs depend significantly on the excipient composition with PVP playing the leading role. Partial mannitol replacement with an amino acid has a limited impact on the tablet properties. The presence of an amino acid also has no impact on the PVP-mannitol interaction. The mechanical and texture properties of freeze-dried ODTs depend non-linearly on the PVP content. The transition between the different types of textures occurs in a narrow range of PVP concentrations regardless of the type of amino acid in a formulation. The non-linear effect of PVP on various tablet properties should be taken into account when designing ODT formulations as it can compromise the robustness of the manufacturing process. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/30631978/Application_of_Texture_Analysis_Technique_in_Formulation_Development_of_Lyophilized_Orally_Disintegrating_Tablets_Containing_Mannitol_Polyvinylpyrrolidone_and_Amino_Acids_ L2 - https://dx.doi.org/10.1208/s12249-018-1269-8 DB - PRIME DP - Unbound Medicine ER -