Orodispersible mini-tablets (ODMT) are a beneficial dosage form for pediatrics and geriatrics. Furthermore they can be used for flexible dosing in broader Patient Groups. A recent study to determine the suitability of agglomerated Isomalt, a Disaccharide alcohol, as a direct compression filler-binder for producing ODMT with hydrochlorothiazide and enalapril maleate, as model commonly used pediatric drugs, is described.

Bio-films are difficult to remove, are often resistant to normal sanitation procedures, and can result in detrimental process effects. Even when a surface appears to be clean the presence of bio-films is a potential hazard that must be eliminated and prevented from reoccurring. The presentation gives insights into avoiding bio-film build up, and the benefits of hygienic seals in safe pharmaceutical production in line with European Hygienic Design Group guidelines.

In today's competitive Pharmaceutical markets, finding production cost advantages is essential. Dry granulation has in the past only been considered beneficial for heat or moisture sensitive products, however with the latest Roller Compactor technologies, this process can be used for a wide range of products.
The presentation will explain the principle of Dry granulation and compare it the more common Wet Granulation process.

What is Industry 5.0? It places the wellbeing of the worker at the centre of the production process and uses new technologies to provide prosperity beyond jobs and growth while respecting the production limits of the planet.” – European Commission

One of the less fortunate features of current life sciences manufacturing is that the procedures and processes we expect personnel to navigate are often complex. We seldom design standard operating procedures with intuitiveness in mind. The complexity and cognitive inaccessibility of many traditional SOPs can result in human error.

Additionally, many SOPs are not written in a task-oriented way. Some examples we have seen even have steps in tasks out of sequence from the way in which they need to be done. Many SOPs tell people what to do, but not how to do it. This results in the development of tacit knowledge to manage the how.

This can result in deviations in practices over time and consequences for the business when the owners of important tacit knowledge leave for retirement or other employment. It can also result in different practices between individuals, teams or shifts.

The key is to have a system that deals with the three “C”s: how to Create your content, how to Curate it and how to Communicate it. When a system like that is in place, you have a much more human-centric environment, as will be seen when each of the three Cs is expanded on during this talk.

One of the major huddles in formulation is to improve the palatability of oral dosage forms, especially now when we are developing medicines for paediatrics and geriatric populations. Palatability is one pharmaceutical attribute of dosage forms which affect patient's acceptability of an oral medicinal product and it is crucial for compliance to their treatment. The non-acceptance of a medicine due to the bad taste can have detrimental consequences on the treatment outcome if the medicine is partially or not taken, leading to suboptimal therapeutic effect to no effect at all. In this presentation we will discuss how we can improve the palatability of oral dosage forms.

This presentation will be an interactive example of how the use of BASF ZoomLab and new Kollitab DC87L can be used to reduce development time and material usage for the formulation of APIs. ZoomLab is a, free, on-line tool that can be used to predict formulations for tabeletting based on the certain parameters. Kollitab DC87L is a co-processed excipient designed for direct compression. Attendees can select the API they wish to see formulated on the booth and the API with most votes will be formulated live, via webex, at the BASF lab in Germany.

Culture media validation is frequently seen as something to be avoided due to the time it takes. It is not as bad as it is
perceived and spending a little time getting this right will pay dividends.
Sometimes the pudding is over egged. Tests done which do not make any sense and because others have performed
them previously. Test layout may be too complex. Site specific aspects are not considered Product specific aspects are
not considered. Discussion will focus on recommendations on the parameters for a meaningful validation. Anticipating
and reducing future deviations with savings in both time and money.