The Influence of Matrix Technology on the Subdivision of Sustained Release Matrix Tablets

Teixeira, Maíra Teles; Barreto, Lívia Cristina Lira de Sá; Taveira, Stephânia Fleury; Gratieri, Taís; Marreto, Ricardo Neves; Silva, Izabel C.; Cunha-Filho, Marcílio

doi:10.1208/s12249-019-1554-1

Cited by 10 publications

(9 citation statements)

References 28 publications

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“…Tablets for controlled release purposes and orally disintegrating tablets might lose predesigned properties when subdivided. [4][5][6] In addition, tablet subdivision might result in two halves that are different in weight and in the corresponding amount of active ingredient. [7][8][9] This can have a serious consequence for potent drugs with a narrow therapeutic index.…”

Section: Introductionmentioning

confidence: 99%

Effect of different splitting techniques on the characteristics of divided tablets of five commonly split drug products in Jordan

Gharaibeh

Tahaineh

2020

Pharm Pract (Granada)

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Objective: To determine the accuracy, variability, and weight uniformity of tablet subdivision techniques utilized to divide the tablets of five drug products that are commonly prescribed for use as half tablets in Jordan. Methods: Ten random tablets of five commonly subdivided drug products were weighed and subdivided using three subdivision techniques: hand breaking, kitchen knife, and tablet cutter. The five commonly subdivided drug products (warfarin 5 mg, levothyroxine 50 μg, levothyroxine 100 μg, candesartan 16 mg, and carvedilol 25 mg) were weighed. The weights were analyzed for acceptance, accuracy, and variability. Weight variation acceptance criteria were adopted in this work as a tool to indicate the properness of the subdivision techniques used to produce acceptable half tablets. Other relevant physical characteristics of the five products such as tablet shape, dimensions, face curvature, score depth, and crushing strength were measured. Results: All tablets were round in shape, had weights that ranged between 100.63 mg (standard deviation=0.99) and 379.04 mg (standard deviation=3.00), and had crushing strengths that ranged between 23.29 N (standard deviation=3.58)and 103.35 N (standard deviation=14.98). Both candesartan and carvedilol were bi-convex in shape with an extent of face curvature equal to about 33%. In addition, percentage score depth of the tablets had a range between 0% and 24%. The accuracy and variability of subdivision varied according to the subdivision technique used and tablet characteristics. Accuracy range was between 81% and 109.8%. Moreover, the relative standard deviation was between 1.5% and 17.4%. Warfarin 5 mg subdivided tablets failed the weight variation test regardless of the subdivision technique used. Subdivision by hand produced half tablets that were acceptable for levothyroxine 50 μg and levothyroxine 100 μg. Subdivision by knife produced half tablets that were acceptable only for candesartan tablets. However, the tablet cutter produced half tablets that passed the weight variation test for four out of the five drug products tested in this study. Conclusions: The tablet cutter performed better than the other subdivision techniques used. It produced half tablets that passed the weight uniformity test for four drug products out of the five.

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Section: Introductionmentioning

confidence: 99%

Effect of different splitting techniques on the characteristics of divided tablets of five commonly split drug products in Jordan

Gharaibeh

Tahaineh

2020

Pharm Pract (Granada)

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“…Nevertheless, studies conducted with different types of matrices have demonstrated that in the case of tablets that preserve their shape for a longer period of time along with the dissolution (such as inert and lipid matrices), the drug diffusion mechanism is decisively influenced by the surface area of the dosage form [16,17]. Hence, the cross-section of the tablet caused by the subdivision gives rise to a new surface, leading to dissolution rate variations of up to 20%, an unacceptable range for a narrow therapeutic window drug such as clomipramine tablets [15].…”

Section: How the Tablet Subdivision Could Affect Different Technologiesmentioning

confidence: 99%

“…In other cases, tablet subdivision has been encouraged and is commonly recommended by manufacturers. Recent studies conducted by our research group and others, however, identify previously ignored problems arising from this practice [11][12][13][14][15]. The scenario becomes even more complicated with the advancement of drug-release technologies employing new materials and processes.…”

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confidence: 95%

Subdivision of modified-release Tablets: state-of-the-art and Future Perspectives

Cunha-Filho

Gelfuso

2020

Ther. Deliv.

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Tablet splitting is a practice disseminated among health professionals for dose adjustments, swallowing facilitation or even treatment cost reduction. Nevertheless, tablets not designed for this purpose cause imprecise dosage and stability loss with important therapeutic repercussions. Novel technologies of modified drug release tablets have come to market including new materials and innovative production processes, for example, polymeric matrix, orodispersible, 3D printing, MUPs, etc. The heterogeneity and complexity of these tablets go well beyond a traditional gastroresistant coating tablet, making orientations on the practice of tablet subdivision difficult. This editorial aims to provide a critical and up-to-date evaluation of this scenario based on the most recent studies involving the subdivision of modified-release tablets.

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“…However, in some studies conducted by different researchers such as Chou et al (2015) reported that unequal tablet splitting causes inaccurate dose titration and even result in toxicity. Another researcher also reported that the subdivision of tablets containing inert matrices greatly affects the kinetic release profile (Teixeira et al, 2020). In another study, the effect of splitting on levothyroxine has been discussed.…”

Section: Introductionmentioning

confidence: 99%

A preliminary study to assess knowledge, preferences, and perception of adult population of Karachi about scored and colored oral solid dosage form

Ali¹,

Mushtaque²,

Khan³

et al. 2020

Afr. J. Pharm. Pharmacol.

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Beyond the pharmacological activity, the differences have been observed in the preferences of solid dosage form on the basis of color and swallowing difficulty in the studies conducted by a different researcher. The aim of the study is to insight the perception of the general population of Karachi about the color, scoring and splitting of tablets. A convenience sampling technique was used to collect data. Knowledge, attitude and practices of the participants regarding oral solid dosage form have been evaluated through a structured close-ended questionnaire. The color perception was pursued by asking questions to the participants about the association of color with effectiveness, identification, safety and onset of action. The scoring perception was also inquired focusing on the association of scoring on the convenience of splitting, their effect on the dose, type of tablet subjected to splitting and further consequences of splitting. Among 426 respondents, 248 participants were not aware of the type of medicine subjected to be splitting. Approximately half of the respondents (N=221) agreed with the point of view that ease of swallowing is one of the reasons for pill-splitting. The study provided preliminary data about color perception, scoring and splitting of tablet dosage form that can be beneficial for future research.

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The Influence of Matrix Technology on the Subdivision of Sustained Release Matrix Tablets

Cited by 10 publications

References 28 publications

Effect of different splitting techniques on the characteristics of divided tablets of five commonly split drug products in Jordan

Effect of different splitting techniques on the characteristics of divided tablets of five commonly split drug products in Jordan

Subdivision of modified-release Tablets: state-of-the-art and Future Perspectives

A preliminary study to assess knowledge, preferences, and perception of adult population of Karachi about scored and colored oral solid dosage form

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