Orally disintegrating mini-tablets (ODMTs) – A novel solid oral dosage form for paediatric use

Stoltenberg, Ines; Breitkreutz, Jörg

doi:10.1016/j.ejpb.2011.02.005

Cited by 176 publications

(106 citation statements)

References 11 publications

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“…In fact, all formulations prepared by Prosolv Õ odt were not successful and showed prolonged WT. This was attributed to the complex structure of Prosolv Õ odt as it contained additional microcrystalline cellulose (MCC) and fructose which might lead to increase WT dependent on the applied compression force, so increasing compression force led to increase in WT (Stoltenberg & Breitkreutz, 2011). Sunada and Bi (2002) studied the difference between WT of tablets containing MCC and L-HPC.…”

Section: Wetting Timementioning

confidence: 99%

A pharmaceutical study on chlorzoxazone orodispersible tablets: formulation, in-vitro and in-vivo evaluation

2016

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Context: Muscle spasm needs prompt relief of symptoms. Chlorzoxazone is a centrally muscle relaxant. Objectives: The aim of this study was to prepare chlorzoxazone orodispersible tablets (ODTs) allowing the drug to directly enter the systemic circulation and bypassing the first-pass metabolism for both enhancing its bioavailability and exerting a rapid relief of muscular spasm. Materials and methods: ODTs were prepared by direct compression method using Pharmaburst Õ 500, Starlac Õ , Pearlitol flash Õ , Prosolv Õ odt and F-melt Õ as co-processed excipients. Three ratios of the drug to the other excipients were used (0.5:1, 1:1 and 2:1). Results and Discussion: All ODTs were within the pharmacopeial limits for weight and content. ODTs containing Pharmaburst Õ 500 showed the shortest wetting time ($45.33 s), disintegration time (DT) ($43.33 s) and dissolution (Q 15min 100.63%). By increasing the ratio of CLZ: Pharmaburst Õ 500 from 0.5:1 to 1:1 and 2:1, the DT increased from 26.43 to 28.0 and 43.33 s, respectively. By using Prosolv Õ odt, ODTs failed to disintegrate in an acceptable time4180 s. DT of ODTs using different co-processed excipients can be arranged as follows: PharmaburstPharmacokinetic study of the optimum formula F1 (50 mg CLZ) in rabbits using HPLC-UV detector revealed a shorter T max (0.333 h) compared with Myofen Õ capsules (250 mg CLZ) (1.083 h) which is considered a promising treatment, especially for the rapid relief of muscle spasm. Conclusion: It could be concluded that orodispersible tablets are a promising carrier for CLZ designed for management of muscle spasm due to the enhanced dissolution and rapid absorption of the drug through the oral mucosa.

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Section: Wetting Timementioning

confidence: 99%

A pharmaceutical study on chlorzoxazone orodispersible tablets: formulation, in-vitro and in-vivo evaluation

2016

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“…22 Table 3 illustrates some of the qualitycertified, innovative oral pediatric dosage forms brought to market, including much needed heat-stable formulations and fixed-dose combination products for low-resource settings. 97,104,[108][109][110][111][112][113][114][115][116] Current surveys reveal that novel oral solids may be used in children at an earlier age than previously anticipated. 5,117,118 Initially, in 2009, Thomson et al 119 demonstrated that 46% of 2-year-old children and 86% of 5-year-old children could swallow innovative 3-mm mini-tablets without choking or aspiration.…”

Section: Novel Oral Pediatric Formulationsmentioning

confidence: 99%

Pediatric Drug Formulations: A Review of Challenges and Progress

et al. 2014

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Children differ from adults in many aspects of pharmacotherapy, including capabilities for drug administration, medicine-related toxicity, and taste preferences. It is essential that pediatric medicines are formulated to best suit a child' s age, size, physiologic condition, and treatment requirements. To ensure adequate treatment of all children, different routes of administration, dosage forms, and strengths may be required. Many existing formulations are not suitable for children, which often leads to off-label and unlicensed use of adult medicines. New regulations, additional funding opportunities, and innovative collaborative research initiatives have resulted in some recent progress in the development of pediatric formulations. These advances include a paradigm shift toward oral solid formulations and a focus on novel preparations, including flexible, dispersible, and multiparticulate oral solid dosage forms. Such developments have enabled greater dose flexibility, easier administration, and better acceptance of drug formulations in children. However, new pediatric formulations address only a small part of all therapeutic needs in children; moreover, they are not always available. Five key issues need to be addressed to stimulate the further development of better medicines for children: (1) the continued prioritization of unmet formulation needs, particularly drug delivery in neonates and treatment gaps in pediatric cancers and childhood diseases in developing countries; (2) a better use of existing data to facilitate pediatric formulation development; (3) innovative technologies in adults that can be used to develop new pediatric formulations; (4) clinical feedback and practice-based evidence on the impact of novel formulations; and (5) improved access to new pediatric formulations. Pediatrics

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“…Child-appropriateness of a dosage form is indicated by easy administration, palatability, possibility for weight-based dosing and dose titration, convenient handling as well as the use of safe, wellestablished and stable excipients [1]. This facilitates formulation acceptability and medication adherence.…”

Section: Challenges Associated With the Development Of A Pharmaceuticmentioning

confidence: 99%

“…In 2008, a WHO expert forum proposed a shift toward pediatric oral solids in view of stability problems and the high transportation and storage costs involved in liquid formulations [1,6]. From then, flexible oral solid dosage forms, such as orodispersible tablets and/or tablets used to prepare oral liquid preparations suitable for younger children, have become the recommended pediatric dosage forms worldwide.…”

Section: Challenges Associated With the Development Of A Pharmaceuticmentioning

confidence: 99%

“…In recent years, both European and United States regulations on pediatric medicines and recent World Human Organization recommendations have induced an increased need for research into novel child -appropriate dosage forms [1]. Indeed, children cannot be considered as « small adults » as they present different anatomical, physiological and psychological characteristics and these influence the therapeutic approach that is taken.…”

Section: Introductionmentioning

confidence: 99%

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Multi-Particulate Dosage Forms for Pediatric Use

Martínez-Terán¹,

Hoang-Thi²,

Flament³

2017

Pediatr Ther

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In recent years, regulations on pediatric medicines have induced an increased need for research into novel childappropriate dosage forms. Indeed, children cannot be considered as « small adults » as they present different anatomical and physiological characteristics. Whatever the route of administration, the age-appropriateness of the formulation is of major importance and has to be taken into consideration. The development of new pediatric dosage forms encounters technical complexities such as dose modification, ease of administration/swallowing, tastemasking, chemical and physical stability, preservation, considerations of a multi-phase and/or multi-use product, packing, providing/designing the measuring device. Innovations are important and the research of new ways to deliver medicines tends to improve compliance, convenience and pharmacokinetic. Recently, the World Human Organization recommended that small sized solid forms or orally disintegrating solid forms should be favored. Solid multi-particulate systems such as pellets have the advantage to cover a broad range of doses for different patients. Dose adjustment can be accurately done by means of dosing device such as a multi-particulate counting device. Developing multi-particulate dosage form with fast disintegration can be useful for children as they present both advantages of solid and liquid formulations. This led to the concept of Orally Disintegrating Tablet which disintegrates rapidly in the mouth into small particles or pellets. Their small size enables them to be well distributed along the gastrointestinal tract improving the bioavailability while reducing local drug concentration, risk of toxicity and side effects. They offer easy swallowing and dose flexibility for pediatric patients and caregivers. The promising results of our fast disintegrating pellets used in multi-particulate dosage forms indicate that they might be the base of a solid platform technology for pediatric medicines.

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Orally disintegrating mini-tablets (ODMTs) – A novel solid oral dosage form for paediatric use

Cited by 176 publications

References 11 publications

A pharmaceutical study on chlorzoxazone orodispersible tablets: formulation, in-vitro and in-vivo evaluation

A pharmaceutical study on chlorzoxazone orodispersible tablets: formulation, in-vitro and in-vivo evaluation

Pediatric Drug Formulations: A Review of Challenges and Progress

Multi-Particulate Dosage Forms for Pediatric Use

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