Evaluation of Bilayer Tablet Machines—A Case Study

Li, Shun Por; Karth, Marshall G.; Feld, Kenneth M.; Paolo, Louis C. Di; Pendharkar, Chandrashekar M.; Williams, Robert O.

doi:10.3109/03639049509048124

Cited by 20 publications

(9 citation statements)

References 5 publications

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“…If the chemical stability of the APIs is still not acceptable, an alternative is to add a buffer layer between the two API-containing layers. The layer will block activity between the two APIs and thus hinder interaction at the layer interface [8,13,[26][27][28]. This approach, often leads to much better overall chemical stabilization of the final drug product.…”

Section: The Advantages Of Multi-layer Tabletsmentioning

confidence: 99%

“…According to the research conducted by the Li et al [27], the most crucial parameter in the production process of multi-layer tablet is the value of compression force used for the first layer, which affects the adherence of layers. The compression pressure and also punch speed greatly affect the compactibility and resistance to compressibility into the die [51].…”

Section: Compression Forcementioning

confidence: 99%

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Challenges in technology of bilayer and multi-layer tablets: a mini-review

Blicharski

Świąder

Serefko

et al. 2019

Current Issues in Pharmacy and Medical Sciences

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Bilayer and multi-layer tablets are enjoying growing popularity among original drug and generic product manufacturers. Multi-layer tablets have many key benefits compared to classic immediate-release tablets. The use of such solid oral dosage forms simplifies dosing regimens in combination therapy, and thus improves patient compliance. However, the technology of multilayer tablets is demanding and requires precise choice of excipients and production parameters with regard to each technological step. The main benefits of multi-layer tablets, certain aspects of their production and the challenges encountered during the compression process are reviewed in this paper.

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Section: The Advantages Of Multi-layer Tabletsmentioning

confidence: 99%

Section: Compression Forcementioning

confidence: 99%

Challenges in technology of bilayer and multi-layer tablets: a mini-review

Blicharski

Świąder

Serefko

et al. 2019

Current Issues in Pharmacy and Medical Sciences

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show abstract

“…To produce adequate tablet formulation, certain requirements such as sufficient mechanical strength and desired drug release profile must be met. At times, this may be difficult task for formulator to achieve these conditions especially in bilayer tablet formulation, where double compression technique is involved, because of poor flow and compatibility characteristic of the drug which will result in capping and/or lamination [8].…”

Section: Preparation Of Bilayer Tabletsmentioning

confidence: 99%

Bilayer tablet technology: A novel approach

Sadhu¹,

Bopparaju²,

Kantamneni³

2019

GSC Biol. and Pharm. Sci.

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Bilayer tablet is new era for the successful development of controlled release formulation along with various features to provide a way of successful drug delivery system. Controlled release dosage forms have been extensively used to improve therapy with several important drugs. Use of bilayer tablet is a very different aspect for anti-inflammatory and analgesic. Bilayer tablet is suitable for sequential release of two drugs in combination, separate two incompatible substances and also for sustained release tablet in which one Layer is immediate release as initial dose and second layer is maintenance dose. Bilayer tablet is improved beneficial technology to overcome the shortcoming of the single layered tablet. This article provides an overview of the bilayer tablet technology, highlighting the main benefits of this type of oral dosage forms while providing a description of current challenges and advances toward improving manufacturing practices and product quality.

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“…individual layers (2), delamination/layer-separation during manufacturing, and storage (8), insufficient tablet breaking force (6), cross-contamination between the layers (especially for incompatible APIs) (9), and reduced yield (6). Dietrich et al (10) studied the influence of tableting forces and lubricant concentration on the adhesion strength of bi-and tri-layer tablets.…”

Section: Bilayer Tablets Are Generating Great Interest Recently For Tmentioning

confidence: 99%

“…In some chemically sensitive cases an inert layer is added between the two layers to prevent their contact (2).…”

Section: Bilayer Tablets Are Generating Great Interest Recently For Tmentioning

confidence: 99%

Evaluation of the Performance Characteristics of Bilayer Tablets: Part I. Impact of Material Properties and Process Parameters on the Strength of Bilayer Tablets

Kottala¹,

Abebe²,

Sprockel³

et al. 2012

AAPS PharmSciTech

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Abstract. Bilayer tableting technology has gained popularity in recent times, as bilayer tablets offer several advantages over conventional tablets. There is a dearth of knowledge on the impact of material properties and process conditions on the performance of bilayer tablets. This paper takes a statistical approach to develop a model that will determine the effect of the material properties and bilayer compression process parameters on the bonding strength and mode of breakage of bilayer tablets. Experiments were carried out at pilot scale to simulate the commercial manufacturing conditions. As part of this endeavor, a seven-factor half-fraction factorial (2 7−1 ) design was executed to study the effect of bilayer tablet compression process factors on the bonding strength of bilayer tablets. Factors studied in this work include: material properties (plastic and brittle), layer ratio, dwell time, layer sequence, first-and second-layer forces, and lubricant concentration. Bilayer tablets manufactured in this study were tested using the axial tester, as it considers both the interfacial and individual layer bonding strengths. Responses of the experiments were analyzed using PROC GLM of SAS (SAS Institute Inc, Cary, North Carolina). A model was fit using all the responses to determine the significant interactions (p<0.05). The results of this study indicated that nature of materials played a critical role on the strength of bilayer compacts and also on mode of fracture. Bilayer tablets made with brittle materials in both the layers are strongest, and fracture occurred in the first layer indicating that interface is stronger than layers. Significant interactions were observed between the selected factors and these results will provide an insight into the interplay of material properties, process parameters, and lubricant concentration on the bonding strength and mode of breakage of bilayer tablets.

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Evaluation of Bilayer Tablet Machines—A Case Study

Cited by 20 publications

References 5 publications

Challenges in technology of bilayer and multi-layer tablets: a mini-review

Challenges in technology of bilayer and multi-layer tablets: a mini-review

Bilayer tablet technology: A novel approach

Evaluation of the Performance Characteristics of Bilayer Tablets: Part I. Impact of Material Properties and Process Parameters on the Strength of Bilayer Tablets

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