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

Jakubowska, Emilia; Ciepluch, Natalia

doi:10.3390/pharmaceutics13111909

Cited by 23 publications

(6 citation statements)

References 90 publications

(130 reference statements)

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“…In that sense, AMT/LMF generic tablets did not meet uniformity of dosage units test because the AV was greater than 15, and units with around 116% API content were detected, which could be harmful due to overdosing. Based on pharmacopeial recommendations, the performed test was content uniformity to evaluate the homogeneity of dosage units due to factors as the potential segregation during manufacturing [ 56 ], even despite the advances on analytical tools to perform the mass variation test on these cases [ 57 ].…”

Section: Resultsmentioning

confidence: 99%

Quality assessment of oral antimalarial and antiretroviral medicines used by public health systems in Sahel countries

Cáceres-Pérez,

Suárez-González,

Santoveña-Estévez

et al. 2024

PLoS ONE

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Malaria and Human Immunodeficiency Virus infections are among the top 10 causes of death in low income countries. Furthermore, many medicines used in these treatment areas are substandard, which contributes to the high death rate. Using a monitoring system to identify substandard and falsified medicines, the study aims to evaluate the quality of antimalarial and antiretroviral medicines in Sahel countries, assessing site conditions, compliance of medicines with pharmacopoeia tests, formulation equivalence with a reference medicine, and the influence of climate on quality attributes. Ultra Performance Liquid Chromatography methods for eight active pharmaceutical ingredients were validated following the International Conference for Harmonization guideline for its detection and quantification. Quality control consists of visual inspections to detect any misinformation or imperfections and pharmacopeial testing to determine the quality of pharmaceutical products. Medicines which complied with uniformity dosage units and dissolution tests were stored under accelerated conditions for 6 months. Artemether/Lumefantrine and Lopinavir/Ritonavir formulations failed uniformity dosage units and disintegration tests respectively, detecting a total of 28.6% substandard medicines. After 6 months stored under accelerated conditions (40 °C // 75% relative humidity) simulating climatic conditions in Sahel countries, some medicines failed pharmacopeia tests. It demonstrated the influence of these two factors in their quality attributes. This study emphasizes the need of certified quality control laboratories as well as the need for regulatory systems to maintain standards in pharmaceutical manufacturing and distribution in these countries, especially when medicines are transported to rural areas where these climatic conditions are harsher.

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Section: Resultsmentioning

confidence: 99%

Quality assessment of oral antimalarial and antiretroviral medicines used by public health systems in Sahel countries

Cáceres-Pérez,

Suárez-González,

Santoveña-Estévez

et al. 2024

PLoS ONE

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“…Moreover, the pipeline looks at structural defects and not dimensional discrepancies. The pipeline's utility could be expanded if it could detect dimensional discrepancies, as dimensional changes can affect content uniformity [73].…”

Section: Discussionmentioning

confidence: 99%

Virtually Possible: Enhancing Quality Control of 3D-Printed Medicines with Machine Vision Trained on Photorealistic Images

Sun,

Alkahtani,

Gaisford

et al. 2023

Pharmaceutics

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Three-dimensional (3D) printing is an advanced pharmaceutical manufacturing technology, and concerted efforts are underway to establish its applicability to various industries. However, for any technology to achieve widespread adoption, robustness and reliability are critical factors. Machine vision (MV), a subset of artificial intelligence (AI), has emerged as a powerful tool to replace human inspection with unprecedented speed and accuracy. Previous studies have demonstrated the potential of MV in pharmaceutical processes. However, training models using real images proves to be both costly and time consuming. In this study, we present an alternative approach, where synthetic images were used to train models to classify the quality of dosage forms. We generated 200 photorealistic virtual images that replicated 3D-printed dosage forms, where seven machine learning techniques (MLTs) were used to perform image classification. By exploring various MV pipelines, including image resizing and transformation, we achieved remarkable classification accuracies of 80.8%, 74.3%, and 75.5% for capsules, tablets, and films, respectively, for classifying stereolithography (SLA)-printed dosage forms. Additionally, we subjected the MLTs to rigorous stress tests, evaluating their scalability to classify over 3000 images and their ability to handle irrelevant images, where accuracies of 66.5% (capsules), 72.0% (tablets), and 70.9% (films) were obtained. Moreover, model confidence was also measured, and Brier scores ranged from 0.20 to 0.40. Our results demonstrate promising proof of concept that virtual images exhibit great potential for image classification of SLA-printed dosage forms. By using photorealistic virtual images, which are faster and cheaper to generate, we pave the way for accelerated, reliable, and sustainable AI model development to enhance the quality control of 3D-printed medicines.

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“…Tablets are often produced by the fast compression of multicomponent powder portions that consist of the active ingredient and excipients [ 11 ]. Tablets must have certain qualities, including quality, friability, disintegration, and physical consistency.…”

Section: Introductionmentioning

confidence: 99%

Sodium Starch Glycolate (SSG) from Sago Starch (Metroxylon sago) as a Superdisintegrant: Synthesis and Characterization

Putra,

Musfiroh,

Elisa

et al. 2023

Molecules

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The characteristics of sago starch exhibit remarkable resemblances to those of cassava, potato, and maize starches. This review intends to discuss and summarize the synthesis and characterization of sodium starch glycolate (SSG) from sago starch as a superdisintegrant from published journals using keywords in PubMed, Scopus, and ScienceDirect databases by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020). There are many methods for synthesizing sodium starch glycolate (SSG). Other methods may include the aqueous, extrusion, organic solvent slurry, and dry methods. Sago starch is a novel form of high-yield starch with significant development potential. After cross-linking, the phosphorus content of sago starch increases by approximately 0.3 mg/g, corresponding to approximately one phosphate ester group per 500 anhydroglucose units. The degree of substitution (DS) of sodium starch glycolate (SSG) from sago ranges from 0.25 to 0.30; in drug formulations, sodium starch glycolate (SSG) from sago ranges from 2% to 8% w/w. Higher levels of sodium starch glycolate (SSG) (2% and 4% w/w) resulted in shorter disintegration times (within 1 min). Sago starch is more swellable and less enzymatically digestible than pea and corn starch. These investigations demonstrate that sago starch is a novel form of high-yield starch with tremendous potential for novel development as superdisintegrant tablets and capsules.

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

Cited by 23 publications

References 90 publications

Quality assessment of oral antimalarial and antiretroviral medicines used by public health systems in Sahel countries

Quality assessment of oral antimalarial and antiretroviral medicines used by public health systems in Sahel countries

Virtually Possible: Enhancing Quality Control of 3D-Printed Medicines with Machine Vision Trained on Photorealistic Images

Sodium Starch Glycolate (SSG) from Sago Starch (Metroxylon sago) as a Superdisintegrant: Synthesis and Characterization

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