Why is mannitol becoming more and more popular as a pharmaceutical excipient in solid dosage forms?

被引:118
作者
Ohrem, H. Leonhard [1 ]
Schornick, Eva [1 ]
Kalivoda, Adela [1 ]
Ognibene, Roberto [1 ]
机构
[1] Merck KgaA, D-64293 Darmstadt, Germany
关键词
binder; direct compression; excipients; filler; incompatibility; mannitol; solid oral dosage forms; stability; tablet; LACTOSE; INTOLERANCE; COMPACTION; MALABSORPTION; ADSORPTION; BEHAVIOR; TABLETS; SUGAR; DRUGS;
D O I
10.3109/10837450.2013.775154
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Various fillers/binders which are applied for the formulation of solid oral dosage forms are assessed for their benefits and drawbacks, including lactose, sorbitol, mannitol, microcrystalline cellulose and calcium hydrogen phosphate dihydrate. A focus of this work was to evaluate the application of mannitol in comparison to other common fillers/binders as it was observed that this excipient is gaining more and more attention in pharmaceutical formulation development and production. While one of the main advantages of conventional fillers/binders such as lactose, microcrystalline cellulose and calcium hydrogen phosphate dihydrate is their low price level, mannitol excels regarding its physicochemical characteristics such as a low hygroscopicity, a strong inertness towards both the API and the patient's body, its good compactibility and the ability to produce extremely robust tablets. Additionally, the suitability of mannitol for the emerging formulation technology of orally disintegrating tablets is pointed out. In summary, it is emphasized that the selection of the filler/binder is highly individual, depending, for example, on the preferred characteristics of the final solid dosage form, the applied API and the available budget. However, mannitol exhibits many strong advantages which can be expected to result in a more widespread application in the near future.
引用
收藏
页码:257 / 262
页数:6
相关论文
共 50 条
  • [31] A New Frontier for Nondestructive Spatial Analysis of Pharmaceutical Solid Dosage Forms: Spatially Offset Low-Frequency Raman Spectroscopy
    Berzins, Karlis
    Fraser-Miller, Sara J.
    Gordon, Keith C.
    ANALYTICAL CHEMISTRY, 2021, 93 (08) : 3698 - 3705
  • [32] Impact of Processing Parameters on the Quality of Pharmaceutical Solid Dosage Forms Produced by Fused Deposition Modeling (FDM)
    Alhijjaj, Muqdad
    Nasereddin, Jehad
    Belton, Peter
    Qi, Sheng
    PHARMACEUTICS, 2019, 11 (12)
  • [33] Raman microimaging as an analytical technique for simultaneous quantification and localization of active principles in pharmaceutical solid dosage forms
    Sanhueza, Mario I.
    Melendrez, Manuel F.
    von Plessing, Carlos
    Bastidas, Camila Y.
    Neira, Jose Y.
    Freer, Juanita
    Castillo, Rosario del P.
    JOURNAL OF RAMAN SPECTROSCOPY, 2020, 51 (04) : 649 - 659
  • [34] Non-Conventional Applications of Computerized Tomography: Analysis of Solid Dosage Forms Produced by Pharmaceutical Industry
    de Oliveira, Jose Martins, Jr.
    Germano Martins, Antonio Cesar
    XXXII BRAZILIAN WORKSHOP ON NUCLEAR PHYSICS, 2010, 1245 : 153 - +
  • [35] PHARMACEUTICAL HETEROGENEOUS SYSTEMS .4. A KINETIC APPROACH TO STABILITY SCREENING OF SOLID DOSAGE FORMS CONTAINING ASPIRIN
    MAULDING, HV
    ZOGLIO, MA
    PIGOIS, FE
    WAGNER, M
    JOURNAL OF PHARMACEUTICAL SCIENCES, 1969, 58 (11) : 1359 - &
  • [36] Foam granulation: new developments in pharmaceutical solid oral dosage forms using twin screw extrusion machinery
    Thompson, M. R.
    Weatherley, S.
    Pukadyil, R. N.
    Sheskey, P. J.
    DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 2012, 38 (07) : 771 - 784
  • [37] Characterization of palygorskite clay from Piauí, Brazil and its potential use as excipient for solid dosage forms containing anti-tuberculosis drugs
    Daiane dos Santos Soares
    Caio Santana Fernandes
    Antônio Carlos S. da Costa
    Fernanda Nervo Raffin
    Wilson Acchar
    Túlio F. A. de Lima e Moura
    Journal of Thermal Analysis and Calorimetry, 2013, 113 : 551 - 558
  • [38] Thermal behaviour of procaine and benzocaine Part II: compatibility study with some pharmaceutical excipients used in solid dosage forms
    Adriana Fuliaş
    Ionuţ Ledeţi
    Gabriela Vlase
    Călin Popoiu
    Alina Hegheş
    Mihai Bilanin
    Titus Vlase
    Dorina Gheorgheosu
    Marius Craina
    Simona Ardelean
    Dumitru Ferechide
    Otilia Mărginean
    Liana Moş
    Chemistry Central Journal, 7
  • [39] Thermal behaviour of procaine and benzocaine Part II: compatibility study with some pharmaceutical excipients used in solid dosage forms
    Fulias, Adriana
    Ledeti, Ionut
    Vlase, Gabriela
    Popoiu, Calin
    Heghes, Alina
    Bilanin, Mihai
    Vlase, Titus
    Gheorgheosu, Dorina
    Craina, Marius
    Ardelean, Simona
    Ferechide, Dumitru
    Marginean, Otilia
    Mos, Liana
    CHEMISTRY CENTRAL JOURNAL, 2013, 7
  • [40] A criterion for assessing homogeneity distribution in hyperspectral images. Part 2: Application of homogeneity indices to solid pharmaceutical dosage forms
    Rosas, Juan G.
    Blanco, Marcelo
    JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2012, 70 : 691 - 699