Skip to main content
SpringerLink
Log in

Effect of magnesium stearate on the content uniformity of active ingredient in pharmaceutical powder mixtures

  • Published:
AAPS PharmSciTech Aims and scope Submit manuscript

Abstract

The objective of this study was to determine the effect of magnesium stearate on the physical stability of polydisperse powder mixtures. The effects of concentration of magnesium stearate and the time of lubrication of mixtures with magnesium stearate on the content uniformity of the active ingredient in the mixtures were evaluated in a model mixture of lactose and aspirin. These effects were compared in a random mixture of non-interacting components and a mixture based on particle interaction. A statistical model that adequately described the relationship between the factors examined and the response was generated. The model indicated the presence of an interaction between magnesium stearate concentration and lubrication time. At a given concentration of magnesium stearate, there was a significant reduction in the content uniformity of aspirin as the time of lubrication of the mixture with magnesium stearate was increased. This effect was larger in mixtures based on particle interaction than in random mixtures of non-interacting components.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Stewart PJ. Influence of magnesium stearate on the homogeneity of a prednisone-granule ordered mix. Drug Dev Ind Pharm. 1981;7(5):485–495.

    Article  CAS  Google Scholar 

  2. Swaminathan V, Kildsig DO. Effect of particle morphology on the physical stability of pharmaceutical powder mixtures: effect of surface roughness of carrier on the stability of ordered mixtures. Drug Dev Ind Pharm. 2000;26(4):356–373.

    Article  Google Scholar 

  3. Hersey JA. Ordered mixing: a new concept in powder mixing practice. Powder Technol. 1975;11:41–44.

    Article  Google Scholar 

  4. Montgomery DC. Design and Analysis of Experiments. 3rd ed. New York, NY: John Wiley & Sons, Inc; 1991.

    Google Scholar 

  5. Swaminathan V, Kildsig DO. Polydisperse powder mixtures: effect of particle size and shape on mixture stability. Drug Dev Ind Pharm. 2002;28(1):41–48.

    Article  CAS  PubMed  Google Scholar 

  6. Staniforth JN, Rees JE. Electrostatic charge interactions in ordered powder mixes. J Pharm Pharmacol. 1982;34(2):69–76.

    Article  CAS  PubMed  Google Scholar 

  7. Staniforth JN, Rees JE, Lai FK, Hersey JA. Interparticle forces in binary and ternary ordered powder mixes. J Pharm Pharmacol. 1982;34(3):141–145.

    Article  CAS  PubMed  Google Scholar 

  8. Zografi G, Tam S. Wettability of pharmaceutical solids: estimates of solid surface polarity. J Pharm Sci. 1976;65:1145–1149.

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Groton Laboratories, Pfizer Global R&D, Eastern Point Road, 06340, Groton, CT

    Vidva Swaminathan

  2. Department of Industrial and Physical Pharmacy, Purdue University, 47906, West Lafayette, IN

    Dane O. Kildsig

Authors
  1. Vidva Swaminathan
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Dane O. Kildsig
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Vidva Swaminathan.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Swaminathan, V., Kildsig, D.O. Effect of magnesium stearate on the content uniformity of active ingredient in pharmaceutical powder mixtures. AAPS PharmSciTech 3, 19 (2002). https://doi.org/10.1208/pt030319

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1208/pt030319

Keywords

Search

Navigation