Development of fixed dose combination tablets containing zidovudine and lamivudine for paediatric applications

Kayitare, Egide; Vervaet, Chris; Ntawukulilyayo, Jd; Seminega, Benoit; Bortel, Van; Remon, Jean Paul

doi:10.1016/j.ijpharm.2008.11.005

Cited by 38 publications

(35 citation statements)

References 19 publications

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“…Eight studies (Costa et al, 2000;Erramouspe & Jarvi, 1997;Kayitare et al, 2009; Mandal, 1996; 270 Shah et al, 1987; Simons et al, 1982; Stockis et al, 2002;Tuleu et al, 2005) used dissolution 271 profiles to assess halved or segmented tablets. Each study identified differences in dissolution 272 profiles between halved and intact tablets, and, with the exception of the work of Costa et al 273 (2000), considered tablets with a modified-release mechanism.…”

Section: Results and Discussion 188mentioning

confidence: 99%

“…A novel fixed dose combination tablet, containing 300mg zidovudine and 160mg lamivudine, 305 was developed for paediatric HIV patients (Kayitare et al, 2009). The novel product had a 306 rectangular shape (22.4 mm long, 11.2 mm wide) with multiple score lines (depth 0.89 mm, 307 angle 100º) to allow easy breaking into a maximum of 8 subunits.…”

Section: Results and Discussion 188mentioning

confidence: 99%

“…Two studies reported excellent tolerability with both split and intact 399 tablets (Kayitare et al, 2009;Moreland et al, 1989). The one study which split enteric-coated 400 tablets found both treatments to be well tolerated and considered the adverse effects reported to 401 be related to nasogastric tube insertion rather than drug-related (Ferron et al, 2003).…”

Section: Weight Loss During Manipulation 332mentioning

confidence: 99%

“…A square captopril product (Costa et al, 2000) subdivided into 302 halves and quarters, met weight variation limits whereas two circular tablets did not, despite all 303 three products having crossed grooves on one of their faces. 304A novel fixed dose combination tablet, containing 300mg zidovudine and 160mg lamivudine, 305 was developed for paediatric HIV patients (Kayitare et al, 2009). The novel product had a 306 rectangular shape (22.4 mm long, 11.2 mm wide) with multiple score lines (depth 0.89 mm, 307 angle 100º) to allow easy breaking into a maximum of 8 subunits.…”

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confidence: 99%

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A systematic review of the use of dosage form manipulation to obtain required doses to inform use of manipulation in paediatric practice

Richey

Hughes

Craig

et al. 2017

International Journal of Pharmaceutics

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systematic review of the use of dosage form manipulation to obtain required doses to inform use of manipulation in paediatric practice.International Journal of Pharmaceutics http://dx.doi.org/10. 1016/j.ijpharm.2016.12.032 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. This study sought to determine whether there is an evidence base for drug manipulation to obtain 37 the required dose, a common feature of paediatric clinical practice. A systematic review of the 38 data sources, PubMed, EMBASE, CINAHL, IPA and the Cochrane database of systematic 39 reviews, was used. Studies that considered the dose accuracy of manipulated medicines of any 40 dosage form, evidence of safety or harm, bioavailability, patient experience, tolerability, 41 contamination and comparison of methods of manipulation were included. Case studies and 42 letters were excluded. Fifty studies were eligible for inclusion, 49 of which involved tablets 43 being cut, split, crushed or dispersed. The remaining one study involved the manipulation of 44 suppositories of one drug. No eligible studies concerning manipulation of oral capsules or 45 liquids, rectal enemas, nebuliser solutions, injections or transdermal patches were identified. 46Twenty four of the tablet studies considered dose accuracy using weight and/or drug content. In 47 studies that considered weight using adapted pharmacopoeial specifications, the percentage of 48 halved tablets meeting these specifications ranged from 30% to 100%. Eighteen studies 49 investigated bioavailability, pharmacokinetics or clinical outcomes following manipulations 50 which included nine delayed or modified release formulations. In each of these nine studies the 51 entirety of the dosage form was administered. Only one of the 18 studies was identified where 52 drugs were manipulated to obtain a proportion of the dosage form, and that proportion 53 administered. The five studies that considered patient perception found that having to manipulate 54 the tablets did not have a negative impact on adherence. Of the 49 studies only two studies 55 reported investigating children. This review yielded limited evidence to support manipulation of 56 medicines for children. The results cannot be extrapolated between dosage forms, methods of 57 manipulation or between different brands of the same drug. 58 59 4 INTRODUCTION 60Many medicines given to children are used "off-label" because the medicine has only been 61 researched and authorised for adults. Often the dosage form (e.g., tablets, capsules, 62 suppositories) is suitable for administration to adults but not to younger children (Waller, 2007). 63Age...

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Section: Results and Discussion 188mentioning

confidence: 99%

Section: Results and Discussion 188mentioning

confidence: 99%

Section: Weight Loss During Manipulation 332mentioning

confidence: 99%

mentioning

confidence: 99%

See 2 more Smart Citations

A systematic review of the use of dosage form manipulation to obtain required doses to inform use of manipulation in paediatric practice

Richey

Hughes

Craig

et al. 2017

International Journal of Pharmaceutics

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“…However, when using improved tablet geometries accurate dose adaptation can be performed for even one-eighth of the total dose (Kayitare et al 2009). Only few products with scored tablets contain explicit information on divisibility and procedures for splitting (Quinzler et al 2006).…”

Section: Peroral Drug Deliverymentioning

confidence: 99%

Drug Delivery and Formulations

Breitkreutz

Boos

2011

Pediatric Clinical Pharmacology

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Paediatric drug delivery is a major challenge in drug development. Because of the heterogeneous nature of the patient group, ranging from newborns to adolescents, there is a need to use appropriate excipients, drug dosage forms and delivery devices for different age groups. So far, there is a lack of suitable and safe drug formulations for children, especially for the very young and seriously ill patients. The new EU legislation will enforce paediatric clinical trials and drug development. Current advances in paediatric drug delivery include interesting new concepts such as fast-dissolving drug formulations, including orodispersible tablets and oral thin strips (buccal wafers), and multiparticulate dosage forms based on mini-tabletting or pelletization technologies. Parenteral administration is likely to remain the first choice for children in the neonatal period and for emergency cases. Alternative routes of administration include transdermal, pulmonary and nasal drug delivery systems. A few products are already available on the market, but others still need further investigations and clinical proof of concept.

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Drivers for a Change – Manufacturing of Future Medicines for Personalized Drug Therapies

Rantanen

Breitkreutz

2017

Continuous Manufacturing of Pharmaceuticals

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Development of fixed dose combination tablets containing zidovudine and lamivudine for paediatric applications

Cited by 38 publications

References 19 publications

A systematic review of the use of dosage form manipulation to obtain required doses to inform use of manipulation in paediatric practice

A systematic review of the use of dosage form manipulation to obtain required doses to inform use of manipulation in paediatric practice

Drug Delivery and Formulations

Drivers for a Change – Manufacturing of Future Medicines for Personalized Drug Therapies

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