Effect of crystallinity of microcrystalline cellulose on the compactability and dissolution of tablets

Suzuki, Tomohiko; Nakagami, Hiroaki

doi:10.1016/s0939-6411(98)00102-7

Cited by 86 publications

(57 citation statements)

References 9 publications

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“…It is well known that the acid hydrolysis of powdered -cellulose I reduces the degree of polymerization and in turn increases slightly the degree of crystallinity, true density, compact tensile strength and fragmentation tendency [30,31]. In this study, the change in the above properties is only attributed to the polymorphic form, which is evidenced in the powder x-Rays difractograms ( Figure 4).…”

Section: P-xrd Characterizationmentioning

confidence: 59%

Effect of Polymorphism on the Particle and Compaction Properties of Microcrystalline Cellulose

Rojas¹

2013

Cellulose - Medical, Pharmaceutical and Electronic Applications

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Section: P-xrd Characterizationmentioning

confidence: 59%

Effect of Polymorphism on the Particle and Compaction Properties of Microcrystalline Cellulose

Rojas¹

2013

Cellulose - Medical, Pharmaceutical and Electronic Applications

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“…Among the studied variables, MCC proportion (X1) proved to have the greatest impact on powder characteristics, significantly influencing all responses. Cellulose type was shown to have a great influence on the resulting tablet properties (19)(20)(21). Vivapur 102 is a fine-grade microcrystalline cellulose and due to its anisometric particles and low density, its mass flow is lower compared to other diluents (22).…”

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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“…[36][37][38] The XRPD patterns (Figure 4b) for formulation TP illustrate that after blending the dry powder has the distinct peak for anhydrous theophylline at 12.6°(2u) and 7.1°(2u). When the dry powder is moistened during granulation, distinct XRPD reflections for monohydrate occur at approximately 11.4°(2u) and 14.7°(2u).…”

Section: The Theophylline Formulationmentioning

confidence: 99%

Pellet manufacturing by extrusion-spheronization using process analytical technology

et al. 2005

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The aim of this study was to investigate the phase transitions occurring in nitrofurantoin and theophylline formulations during pelletization by extrusion-spheronization. An at-line process analytical technology (PAT) approach was used to increase the understanding of the solid-state behavior of the active pharmaceutical ingredients (APIs) during pelletization. Raman spectroscopy, near-infrared (NIR) spectroscopy, and X-ray powder diffraction (XRPD) were used in the characterization of polymorphic changes during the process. Samples were collected at the end of each processing stage (blending, granulation, extrusion, spheronization, and drying). Batches were dried at 3 temperature levels (60°C, 100°C, and 135°C). Water induced a hydrate formation in both model formulations during processing. NIR spectroscopy gave valuable real-time data about the state of water in the system, but it was not able to detect the hydrate formation in the theophylline and nitrofurantoin formulations during the granulation, extrusion, and spheronization stages because of the saturation of the water signal. Raman and XRPD measurement results confirmed the expected pseudopolymorphic changes of the APIs in the wet process stages. The relatively low level of Raman signal with the theophylline formulation complicated the interpretation. The drying temperature had a significant effect on dehydration. For a channel hydrate (theophylline), dehydration occurred at lower drying temperatures. In the case of isolated site hydrate (nitrofurantoin), dehydration was observed at higher temperatures. To reach an understanding of the process and to find the critical process parameters, the use of complementary analytical techniques are absolutely necessary when signals from APIs and different excipients overlap each other.

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Effect of crystallinity of microcrystalline cellulose on the compactability and dissolution of tablets

Cited by 86 publications

References 9 publications

Effect of Polymorphism on the Particle and Compaction Properties of Microcrystalline Cellulose

Effect of Polymorphism on the Particle and Compaction Properties of Microcrystalline Cellulose

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

Pellet manufacturing by extrusion-spheronization using process analytical technology

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