Effect of moisture and magnesium stearate concentration on flow properties of cohesive granular materials

Faqih, Abdul Mobeen N.; Mehrotra, Amit; Hammond, Stephen V.; Muzzio, Fernando J.

doi:10.1016/j.ijpharm.2006.12.024

Cited by 88 publications

(33 citation statements)

References 7 publications

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“…Lactose and HPMC both showed decreased flowability with increasing moisture content, attributed to increased cohesion from stronger liquid bridges formed from condensed water on the surfaces of the particles (16,17). In contrast, the flowability of aspartame was found to increase with moisture content as the particles formed agglomerates that were that were larger and more spherical than the small and needle-shaped individual particles (16).…”

Section: Introductionmentioning

confidence: 99%

The Effect of Moisture on the Flowability of Pharmaceutical Excipients

2013

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Abstract. The effect of moisture content on flowability of six pharmaceutical powders (microcrystalline cellulose (MCC), hydroxypropyl methylcellulose (HPMC), carboxymethyl cellulose (CMC), polyvinylpyrrolidone (PVP), corn starch, and potato starch) was investigated. Powder flowability was measured using established static techniques and emerging dynamic avalanche behavior measurements. Static techniques did not provide enough resolution to clearly identify changes in flowability due to increasing powder moisture content. Avalanche time and its standard deviation showed that flowability of MCC, CMC, PVP, and potato starch decreased after a critical moisture content, flowability of corn starch increased and flowability did not significantly change for HPMC. The moisture decreased flowability by forming stronger interparticle liquid bridges and increased flowability by acting as a lubricant. The dynamic density of the celluloses and PVP decreased linearly with increasing moisture content as the particles swelled with water. The starches also swelled and decreased in dynamic density, but only after a moisture content corresponding to monolayer coverage of water around the particles was reached. As flowability and dynamic density change with moisture content, to ensure consistent production of high-quality tablets, the moisture content of the powders must be measured and controlled.

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Section: Introductionmentioning

confidence: 99%

The Effect of Moisture on the Flowability of Pharmaceutical Excipients

2013

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“…This behavior came as a surprise, since increased magnesium stearate content of powders was linked with improved flow characteristics (24)(25)(26) by reducing adhesion and capillary forces (27,28). Lubrication, however, is not only dependent on the lubricant content, but also on the blending time and mixing intensity.…”

Section: Evaluation Of Variables Affecting Powder Mixture Propertiesmentioning

confidence: 99%

Study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental design

Szabó

Székely-Szentmiklósi²,

Deák

et al. 2016

Acta Pharmaceutica

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Study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental designTo evaluate the influence of different variables on tablet formulations containing enalapril maleate and indapamide as active substances, two separate experimental designs were employed: one for evaluating powder properties and the other for tablet characteristics. Because of the low active pharmaceutical ingredient content, it was hypothesized that both powder and tablet properties could be determined only by the characteristics of excipients. In order to test this assumption, both experimental designs were done with placebo mixtures. The optimized formulation was then evaluated both with and without APIs. Results indicated that filler and lubricant percentage, along with compression force, were the most important variables during the formulation study. The optimized formulation showed similar characteristics in both cases for all responses, except for angle of repose and friability where only minor differences were observed. The combination of the applied approaches (using placebo composition and fractional experimental design) proved to be efficient, cost effective and time saving.Keywords: design of experiments, optimization, factorial design, placebo formulation Proper management of hypertension, one of the leading causes of cardiovascular disease, is of the utmost importance. It has been established that lowering of blood pressure can effectively reduce the risk of cardiovascular events and stroke, but finding the most appropriate therapy is often difficult (1). Combinational therapies employing an angiotensin-converting enzyme inhibitor (ACEi) and indapamide (IND) offer the advantage of using two highly effective agents, increasing both clinical efficiency and patient compliance (2-4). Low dose combinations of ACEis and diuretics have shown greater reduction in blood pressure and higher success rates in managing hypertension than either of the treatments alone (4-6). The most popular ACEis present in these combinations include perin- Szabo et al.: Study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental design, Acta Pharm. 66 (2016) 191-206.

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“…For instance, for a free-flow blend, the effect of the lubricant on the blend flowability is not significant. However, as the blend becomes more cohesive, the presence of lubricant greatly improves its flowability [29]. In addition, the flowability of the blends containing an API is also related to the API particle size and size distribution.…”

Section: Effect Of Powder Properties On Lubricationmentioning

confidence: 99%

Lubricants in Pharmaceutical Solid Dosage Forms

2014

Lubricants

175

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Lubrication plays a key role in successful manufacturing of pharmaceutical solid dosage forms; lubricants are essential ingredients in robust formulations 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. In this paper, the fundamental background on lubrication is introduced, in which the relationships between lubrication and friction/adhesion forces are discussed. Then, 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 its hydration state (anhydrate, monohydrate, dihydrate, and trihydrate) and its powder characteristics on lubrication efficiency, as well as product and process performance is summarized. In addition, the impact of lubrication on the dynamics of compaction/compression processes and on the mechanical properties of compacts/tablets is presented. Furthermore, the online monitoring of magnesium stearate in a blending process is briefly mentioned. Finally, the chemical compatibility of active pharmaceutical ingredient (API) with magnesium stearate and its reactive impurities is reviewed with examples from the literature illustrating the various reaction mechanisms involved.

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Effect of moisture and magnesium stearate concentration on flow properties of cohesive granular materials

Cited by 88 publications

References 7 publications

The Effect of Moisture on the Flowability of Pharmaceutical Excipients

The Effect of Moisture on the Flowability of Pharmaceutical Excipients

Study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental design

Lubricants in Pharmaceutical Solid Dosage Forms

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