scholarly journals Blend Segregation in Tablets Manufacturing and Its Effect on Drug Content Uniformity—A Review

Pharmaceutics ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 1909
Author(s):  
Emilia Jakubowska ◽  
Natalia Ciepluch

Content uniformity (CU) of the active pharmaceutical ingredient is a critical quality attribute of tablets as a dosage form, ensuring reproducible drug potency. Failure to meet the accepted uniformity in the final product may be caused either by suboptimal mixing and insufficient initial blend homogeneity, or may result from further particle segregation during storage, transfer or the compression process itself. This review presents the most relevant powder segregation mechanisms in tablet manufacturing and summarizes the currently available, up-to-date research on segregation and uniformity loss at the various stages of production process—the blend transfer from the bulk container to the tablet press, filling and discharge from the feeding hopper, as well as die filling. Formulation and processing factors affecting the occurrence of segregation and tablets’ CU are reviewed and recommendations for minimizing the risk of content uniformity failure in tablets are considered herein, including the perspective of continuous manufacturing.

2010 ◽  
Vol 93-94 ◽  
pp. 672-674 ◽  
Author(s):  
Varatus Vongsurakrai ◽  
Saiyavit Varavinit

Spray dried rice starch (SDRS ) (Era-Tab ®)was prepared by spray drying of rice starch at a suitable condition. Scanning electron microscope revealed that particle of SDRS was spherical and made up entirely agglomerates of rice starch grains. Tablet properties of SDRS were studied and compared with those of three commercially available direct compression fillers. Hardness, friability, and disintegration of the tablets were evaluated. It was found that SDRS was inferior to only one of them. Segregation tendency of direct compression formulation containing SDRS as a major component was tested. A blend of propranolol hydrochloride and SDRS was tableted on an rotary tablet press. Dissolution and drug content were evaluated. The results indicated that segregation did not occur over a two-hour period. To demonstrate the uniform distribution of low-dose drug, a mixture of SDRS and chlorpheniramine maleate were prepared at 4% of the drug. The tablets were assayed for the content uniformity and found to be excellent. Since direct compression process avoided the use of heat and moisture which were normally employed in wet granulation process, aspirin which was a heat and moisture sensitive drug was formulated with the use of SDRS. The tablets obtained were found to be satisfactory. Therefore, it was concluded that it could be employed successfully as a filler in direct compression tableting


2002 ◽  
Vol 37 (5) ◽  
pp. 497-502 ◽  
Author(s):  
Banu F. Ozen ◽  
Lisa L. Dock ◽  
Murat Ozdemir ◽  
John D. Floros

1969 ◽  
Vol 48 (6) ◽  
pp. 2018-2022 ◽  
Author(s):  
Stuart T. McCready ◽  
J. David Mitchell

Pharmaceutics ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 124 ◽  
Author(s):  
Mohammad A. Azad ◽  
Deborah Olawuni ◽  
Georgia Kimbell ◽  
Abu Zayed Md Badruddoza ◽  
Md. Shahadat Hossain ◽  
...  

Three dimensional (3D) printing as an advanced manufacturing technology is progressing to be established in the pharmaceutical industry to overcome the traditional manufacturing regime of 'one size fits for all'. Using 3D printing, it is possible to design and develop complex dosage forms that can be suitable for tuning drug release. Polymers are the key materials that are necessary for 3D printing. Among all 3D printing processes, extrusion-based (both fused deposition modeling (FDM) and pressure-assisted microsyringe (PAM)) 3D printing is well researched for pharmaceutical manufacturing. It is important to understand which polymers are suitable for extrusion-based 3D printing of pharmaceuticals and how their properties, as well as the behavior of polymer–active pharmaceutical ingredient (API) combinations, impact the printing process. Especially, understanding the rheology of the polymer and API–polymer mixtures is necessary for successful 3D printing of dosage forms or printed structures. This review has summarized a holistic materials–process perspective for polymers on extrusion-based 3D printing. The main focus herein will be both FDM and PAM 3D printing processes. It elaborates the discussion on the comparison of 3D printing with the traditional direct compression process, the necessity of rheology, and the characterization techniques required for the printed structure, drug, and excipients. The current technological challenges, regulatory aspects, and the direction toward which the technology is moving, especially for personalized pharmaceuticals and multi-drug printing, are also briefly discussed.


2000 ◽  
Vol 11 (11) ◽  
pp. 3777-3789 ◽  
Author(s):  
Tracy Stage-Zimmermann ◽  
Ute Schmidt ◽  
Pamela A. Silver

In Saccharomyces cerevisiae, the 60S ribosomal subunit assembles in the nucleolus and then is exported to the cytoplasm, where it joins the 40S subunit for translation. Export of the 60S subunit from the nucleus is known to be an energy-dependent and factor-mediated process, but very little is known about the specifics of its transport. To begin to address this problem, an assay was developed to follow the localization of the 60S ribosomal subunit inS. cerevisiae. Ribosomal protein L11b (Rpl11b), one of the ∼45 ribosomal proteins of the 60S subunit, was tagged at its carboxyl terminus with the green fluorescent protein (GFP) to enable visualization of the 60S subunit in living cells. A panel of mutant yeast strains was screened for their accumulation of Rpl11b–GFP in the nucleus as an indicator of their involvement in ribosome synthesis and/or transport. This panel included conditional alleles of several rRNA-processing factors, nucleoporins, general transport factors, and karyopherins. As predicted, conditional alleles of rRNA-processing factors that affect 60S ribosomal subunit assembly accumulated Rpl11b–GFP in the nucleus. In addition, several of the nucleoporin mutants as well as a few of the karyopherin and transport factor mutants also mislocalized Rpl11b–GFP. In particular, deletion of the previously uncharacterized karyopherin KAP120 caused accumulation of Rpl11b–GFP in the nucleus, whereas ribosomal protein import was not impaired. Together, these data further define the requirements for ribosomal subunit export and suggest a biological function for KAP120.


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