Tablets & Capsules


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Tablets & Capsules October 2020 33 eye on excipients This edition of Eye on Excipients dis- cusses orodispersible minitablets as an alternative dosage form for pediatric patients and others who have difficulty swallowing traditional tablets. The col- umn also describes a study conducted to determine the suitability of agglomerated isomalt as a filler-binder for direct-com- pression orodispersible minitablets with a low drug load. Oral drug delivery by tablet is the most convenient route of administra- tion for a medicine. However, some patient groups have difficulty swal- lowing (dysphagia) or have format, taste, and texture preferences that require alternative administration methods. For this reason, formulators are striving to develop new tablet formulations that promote improved patient compliance and convenience. These include orodispersible tablets (ODTs), minitablets, and orodispers- ible minitablets (ODMTs). ODTs are solid-unit dosage forms, which disintegrate or dissolve rapidly in the mouth without chewing or taking water. ODTs are particularly advantageous for pediatric and geri- atric populations, who have difficulty swallowing conventional tablets and capsules. The European Pharmaco- poeia has defined the term orodis- persible tablet as a tablet that dis- perses readily and within 3 minutes in the mouth before swallowing [1]. The US FDA defines an ODT as a "solid dosage form containing medicinal substances which disinte- grates rapidly, usually within a matter of seconds, when placed upon the tongue" [2]. Based on the original product rationale and FDA experi- ence, we recommend that, in addi- tion to the original definition, ODTs be considered solid oral preparations that disintegrate rapidly in the oral cavity, with an in-vitro disintegration time of approximately 30 seconds or less, when based on the United States Pharmacopeia (USP) disinte- gration test method or an alternative. There is no universal definition for minitablets, but they are gen- erally accepted to be compressed tablets with a diameter of 2 to 3 millimeters, as shown in Photo 1. Acceptance studies have shown that minitablets are suitable for use as a single dose and as multiparticu- lates for pediatrics [3]. Minitablets could also be a suitable administra- tion form for other patient groups with dysphagia and the elderly. Minitablets can be manufactured on regular rotary tablet presses with a few minor adjustments and the use of appropriate multi-tip punches (Photo 2). Due to their small size, minitablet formulations can present challenges with respect to blend uniformity, flow properties, and mass uniformity. Therefore, the choice of fill- er-binder in a minitablet formula- tion is important. The filler-binder should have powder and compres- sion characteristics that promote both high content uniformity and relatively high tablet hardness at low compression force. The following study was con- d u c t e d t o e v a l u a t e t h e u s e o f agglomerated isomalt as the fill- er-binder in a pediatric ODMT formulation containing enalapril maleate as the low-dose active phar- maceutical ingredient (API) [4]. Michael Black, Maj-Britt Cepok, and Oliver Luhn Beneo Photo 1: Minitablets are generally accepted to be compressed tablets with a diameter of 2 to 3 millimeters. Photo 2: Minitablets are manufactured on regular rotary tablet presses using multi-tip punches (center). Copyrights (HHU, Klaus Knop)

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