Comparison of Different Liquid and Semisolid Vehicles Selected for Oral Administration of Pellets and Minitablets with D
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Research Article Comparison of Different Liquid and Semisolid Vehicles Selected for Oral Administration of Pellets and Minitablets with Diazepam: In Vitro Investigation Hanna Kotlowska,1 Marta Szymanska,2 and Malgorzata Sznitowska1,3
Received 9 May 2020; accepted 11 July 2020 Abstract.
The acceptability and palatability of a dosage form are extremely important to improve patient compliance. Mixing oral solid dosage forms with food carriers is often necessary to ease swallowing and provide the taste-masking effect. The present research investigated how a liquid or semisolid carrier influences the disintegration time and drug dissolution rate of pellets and minitablets with diazepam. The disintegration of pellets and minitablets in liquid carriers (water, milk and apple juice) was determined using a texture analyser. Dissolution tests were performed for the dosage forms dispersed in gel vehicles (2% carmellose and 0.5% carbomer gels) or applesauce. The disintegration of minitablets in water and apple juice was fast (1 min), but it slowed to 3 and 5 min in milk and gel vehicles, respectively. The pellets disintegrated in liquid carriers within 3 min. The drug dissolution rate in 0.1 M HCl depended on the gel viscosity in this medium. The preserved high viscosity of a carmellose gel inhibited the dissolution of diazepam. On the other hand, the viscosity of the carbomer gel decreased rapidly, and in effect, the dissolution rate of diazepam from the incorporated pellets or minitablets was comparable to the dissolution from loose pellets or minitablets.
KEY WORDS: pellets; minitablets; sprinkle; disintegration; dissolution.
INTRODUCTION Swallowing difficulties (dysphagia) are becoming more common. Approximately 70–90% of the elderly and 25–45% of children experience swallowing problems (1). The lack of commercially available, age-appropriate medicinal products forces patients and caregivers to manipulate the dosage form, including breaking or crushing the tablets or mixing them with food or drink. All of these actions may reduce clinical efficacy or increase the risk of adverse reactions when the chemical and physical stability or bioavailability is affected (2). Sprinkles are a new medicinal product of multiparticulate solid oral dosage forms dedicated for mixing with soft food or liquids (3). Sprinkles occur as beads (e.g., granules, pellets, or minitablets) packed in capsules or sachets that are designed to be removed and mixed with a liquid or a soft food before administration, to improve swallowability. The carrier supports the taste-masking properties, which significantly
1
Department of Pharmaceutical Technology, Medical University of Gdansk, Al. Hallera 107, 80-416, Gdansk, Poland. 2 Student Chapter of the ISPE, Department of Pharmaceutical Technology, Medical University of Gdansk, Gdańsk, Poland. 3 To whom correspondence should be addressed. (e–mail: [email protected])
improve patient compliance. Several studies showed that sprinkles are more acceptable by children and their caregivers than liquid dosage fo
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