Lubricants in Pharmaceutical Solid Dosage Forms With Special Emphasis on Magnesium Stearate

Abstract

Lubrication plays a key role in successful manufacturing of pharmaceutical solid dosage form; lubricants are essential ingredients in robust formulation to achieve this. Although many failures in pharmaceutical manufacturing operations are caused by issues related to lubrication, in general, lubricants do not gain adequate attention in the development of pharmaceutical formulations. The addition of lubricants also affect tablet properties and can affect the behaviour of the powder mixture. In this review, the fundamental background on lubrication is introduced, in which the relationships between lubrication and friction/adhesion forces are discussed. The application of lubrication in the development of pharmaceutical products and manufacturing processes is discussed with an emphasis on magnesium stearate. In particular, the effect of hydration state (anhydrate, monohydrate, dihydrate, and trihydrate) of a lubricant like Magnesium stearate and its powder characteristics on lubricant efficiency, as well as product and process performance is summarized.KEYWORD: lubricant, magnesium stearate, efeect of lubricant on tablet properties.

Study of the tableting properties of MCR, a newly co-processed cellulose based direct compression excipient

“…This is due to the powerful disintegration effect of CRC 15 . Incorporating a powerful disintegrant in formulating tablets would contribute to the bio-response of the tablets 26 . MCR was unfortunately sensitive against MS.…”

Application of co-processed excipients for developing fast disintegrating tablets: A review

“…[19][20][21] The most commonly used excipients in the tablet dosage form are diluents, binders, disintegrants, glidants, lubricants, surfactants, pH-adjusting agents, sugar (as sweetening agent), mucoadhesive polymers, and coating and coloring agents. 22 [23][24][25][26][27][28][29][30] For the development of FDTs, superdisintegrants are widely used in the pharmaceutical industry to minimize the disintegration time. Agar powder and amino acids are examples of naturally available disintegrants that are used in the preparation of FDTs.…”

“…Binders provides plasticity and boosts the interparticulate bonding strength in tablet starch, gelatin, acacia [23] and [24] Disintegrants/ superdisintegrants rapidly absorbs water and results in a quick breakdown of tablet crosscarmellose sodium, crosspovidone [25] and [26] Diluents produces desired/required bulk of the tablet microcrystalline cellulose, lactose monohydrate, calcium phosphate dehydrate [27] Lubricants minimizes tablet adhesion with the surface of dies and punches magnesium stearate, talc, silica [28] Glidants improves flowability characteristics colloidal silicon dioxide, talc [28] Coloring agent improves tablet appearance and patient acceptance dyes and pigments [29] Flavoring agent employed in orodispersible tablets, assures a better mouth feel peppermint oil, spearmint oil [30] novel excipients types of excipients single-entity excipients multiple excipients co-processed excipients…”

Additive Manufacturing of Oral Tablets: Technologies, Materials and Printed Tablets

“…Lubricants are essential for robust and successful manufacturing of tables for both conventional and additive manufacturing approaches. A good lubricant should have low shear strength, should not be toxic and should not be affected by the process variables [126]. Lubricants can be either hydrophilic or hydrophobic; however, hydrophobic ones are more frequently used because they are effective at low concentrations.…”