Browsing by Subject "dosage form"

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  • Kukkola, Elias (Helsingfors universitet, 2014)
    In early clinical trials of drug development capsule is preferable compared with other solid dosage forms, including tablets, because of its simplicity and blinding capabilities. However a simple capsule formulation is not viable in large-scale production. Usually it's either switched to an economical tablet formulation or to another capsule formulation that can be manufactured on large-scale equipment. Tablets are nearly always formulated for commercialization if they're not technologically impossible to manufacture for a reason which could be bad compression or solubility of a drug. Tablet-pressing process sets more-demanding requirements for pharmaceutical powder properties than encapsulation process, because tablet-press uses larger compression forces and it measures the dose in a different way. The most common problems faced when switching from a capsule dosage form to tablet-pressing process are poor powder flow properties and weak mechanical strength, capping and lamination of tablets. The purpose of this work was to investigate the critical pharmaceutical and technical properties to succeed in switching from a capsule dosage form to a tablet dosage form and tablet-pressing process. The starting point of this work was a simple capsule formulation consisting of carbidopa, directcompressible mannitol and pregelatinized maize starch. The simple formulation was used to build up two mixture designs consisting of very different powder properties to study the critical powder properties and process variables involved in the switch. The capsules were filled on a dosating nozzle capsule-filling machine and the tablets were pressed on a pneumohydraulic tablet press. Weight variability, disintegration time, encapsulation and tabletability were used as the responses of the dosage forms. As a result of the study the automatic capsule-filling machine filled many different types of powders in capsules with low fill-weight variability. The most critical powder properties affecting the capsulefilling process were the particle size, bulk and tapped densities and cohesion of powder. Avicel PH200 improved the tabletability and flowability of the powders, but it also increased the fill-weight variability of the capsules. In this work single powder flow properties described only the flowability of a powder, but they did not determine the performance of a powder in the processes. Therefore, measuring various powder flow properties and correlating them to a manufacturing system is necessary to understand the process. Avicel PH102 was proved to work as an ideal reference material for evaluating the sufficiency of the flow properties of a powder in the tablet-pressing process.
  • Niittymäki, Johanna (Helsingfors universitet, 2017)
    There are many challenges in use of dosage forms in medication of elderly people. Especially swallowing of solid dosage forms can be difficult. Dosage forms are often altered to enhance drug intake. Medication adherence is a major contributor to the success of therapy. Adherence is a multidimensional phenomenon which is also affected by properties of medicinal product. Theoretical framework of this thesis is World Health Organization's multidimensional adherence model. Only few studies exist on how properties of dosage forms affect to the success of medical treatment of elderly. The aim of this study was to find out what kind of difficulties related to dosage forms occur in medical treatment of elderly people living in nursing homes. Future goal is to develop dosage forms better suited to elderly and hence improve their medication adherence. This study consisted of interviews and e-survey. This study was carried out in six nursing homes where 322 elderly residents fulfilled the inclusion criteria of the study. Nurses (n = 48) were interviewed to explore their views on difficulties related to dosage forms. Other difficulties in use of dosage forms were also surveyed as well as frequency of tablet crushing. Difficulties in use of dosage forms on the medical treatment of the elderly were gathered in the e-survey. Also, the need to crush tablets and open capsules was surveyed as well as need to split tablets to obtain the dose needed. Difficulties in use of dosage forms are common in medical treatment of elderly people. Majority of the interviewed nurses has encountered these difficulties at least few times a week. The most common problematic dosage form was the tablet. About half of the nurses named the big size of tablets and capsules as the most important difficulty in the use of current oral or peroral dosage forms. Over half of the nurses have crushed or given crushed drug daily. The most common reason for dosage form altering was the big size of the medicinal product. Majority of the nurses has often encountered also other than dosage form related difficulties of which the most common challenges are related to suspiciousness. In e-survey, nurses submitted entries regarding 111 elder people. Most cases were related to splitting of a tablet to obtain the desired drug dose. Tablet crushing was reported for little less than one-fifth of the elderly people. Both the splitting and crushing entries were distributed over multiple different medicinal products. Some other difficulties related to dosage forms were reported for less than one-tenth of the elderly people. Based on this study more appropriate dosage forms should be developed for the medical treatment of elderly people. Oral solutions, orodispersible tablets as well as transdermal patches all have advantages. Pharmaceutical research and development can facilitate medical treatment of elderly people and hence improve their medication adherence by introducing more appropriate dosage forms.