Large-volume metrology instrument selection and measurability analysis

A wide range of metrology processes are involved in the manufacture of large products. In addition to the traditional tool-setting and product-verification operations, increasingly flexible metrology-enabled automation is also being used. Faced with many possible measurement problems and a very large number of metrology instruments employing diverse technologies, the selection of the appropriate instrument for a given task can be highly complex. Also, as metrology has become a key manufacturing process, it should be considered in the early stages of design, and there is currently very little research to support this. This paper provides an overview of the important selection criteria for typical measurement processes and presents some novel selection strategies. Metrics that can be used to assess measurability are also discussed. A prototype instrument selection and measurability analysis application is also presented, with discussion of how this can be used as the basis for development of a more sophisticated measurement planning tool. © 2010 Authors.

Application and use of isothermal calorimetry in pharmaceutical development

There are many steps involved in developing a drug candidate into a formulated medicine and many involve analysis of chemical interaction or physical change. Calorimetry is particularly suited to such analyses as it offers the capacity to observe and quantify both chemical and physical changes in virtually any sample. Differential scanning calorimetry (DSC) is ubiquitous in pharmaceutical development, but the related technique of isothermal calorimetry (IC) is complementary and can be used to investigate a range of processes not amenable to analysis by DSC. Typically, IC is used for longer-term stability indicating or excipient compatibility assays because both the temperature and relative humidity (RH) in the sample ampoule can be controlled. However, instrument design and configuration, such as titration, gas perfusion or ampoule-breaking (solution) calorimetry, allow quantification of more specific values, such as binding enthalpies, heats of solution and quantification of amorphous content. As ever, instrument selection, experiment design and sample preparation are critical to ensuring the relevance of any data recorded. This article reviews the use of isothermal, titration, gas-perfusion and solution calorimetry in the context of pharmaceutical development, with a focus on instrument and experimental design factors, highlighted with examples from the recent literature. © 2011 Elsevier B.V.

Dosage form preference consultation study in children and young adults:paving the way for patient-centred and patient-informed dosage form development

Objectives: The current study aims to evaluate dosage form preferences in children and young adults together with identifying the key pragmatic dosage form characteristics that would enable appropriate formulation of orally disintegrating tablets (ODTs). Methods: International, multisite, cross-sectional questionnaire of children and young adults aged from 6 to 18 years. Eligibility was based on age, ability to communicate and previous experience in taking medications. The study was carried out at three locations: the UK, Saudi Arabia and Jordan. The questionnaire instrument was designed for participant self-completion under supervision of the study team.Results 104 questionnaires were completed by the study cohort (n=120, response rate 87%). Results: showed that ODTs were the most preferred oral dosage forms (58%) followed by liquids (20%), tablets (12%) and capsules (11%). The preferred colours were pink or white while the preferred size was small (<8 mm) with a round shape. With regard to flavour, strawberry was the most preferred (30.8%), while orange was the least preferred (5.8%). The results also showed that the most important physical characteristics of ODTs were disintegration time followed by taste, size and flavour, respectively. Conclusions: The results of our study support the WHO's claim for a shift of paradigm from liquid towards ODTs dosage forms for drug administration to young children older than 6 years. Data from this study will also equip formulators to prioritise development of key physical/performance attributes within the delivery system.

Large volume metrology instrument selection and measurability analysis

Metrology processes used in the manufacture of large products include tool setting, product verification and flexible metrology enabled automation. The range of applications and instruments available makes the selection of the appropriate instrument for a given task highly complex. Since metrology is a key manufacturing process it should be considered in the early stages of design. This paper provides an overview of the important selection criteria for typical measurement processes and presents some novel selection strategies. Metrics which can be used to assess measurability are also discussed. A prototype instrument selection and measurability analysis application is presented with discussion of how this can be used as the basis for development of a more sophisticated measurement planning tool. © Springer-Verlag Berlin Heidelberg 2010.