Target Audience:

This short course is intended to provide a useful background on contemporary solid stateand solution characterization of API’s as well as to provide a framework for translating thesedata into useful formulations. The course is designed to be useful to both scientists new tothe field as well as the experienced pharmaceutical researcher with an eye towards the stateof the art and future direction.

Research & Development

06 to 07 May 2015

Brussels, Belgium

Course no. 6586

MAKING SCIENCE WORK

Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V.Gemeinnütziger wissenschaftlicher VereinInternational Association for Pharmaceutical Technology

APV basics: Preformulation

APVbasics

Preformulation is an essential step in the pharmaceu-tical development of an API. It is the process by whichcandidate drugs are characterized with respect to theappropriateness to be formulated and processed to auseful dosage form. During this phase of the deve-lopment, information about the physicochemical pro-perties (e.g., solubility, ionization behavior, solid stateproperties,…), biopharmaceutical properties (e.g.,permeability through bio-membranes) and stability profile (physical, chemical, compatibility withexcipients, etc.) of the drug candidate is collected.This information guides the formulation scientist as itwill dictate many of the possible formulation and pro-cessing approaches.

This basic course is divided into three parts. In thefirst part, fundamental physicochemical and biophar-maceutical concepts are discussed including solubilityand dissolution rate, ionization behavior, partitioning,solid state properties (polymorphism, amorphous andcrystalline state), salts and salt selection, physical andchemical stability, powder properties and drugabsorption profiling. Analytical techniques to assesssolid state properties such as X-ray diffraction, diffe-rential scanning calorimetry, dynamic vapour sorptionand thermogravimetric analysis are briefly discussedand illustrated with examples.

In a second module, automation and down-scaling ofpreformulation assessments will be discussed. This ispresented in the contest of dosage form type selecti-on where both conventional and enabled formulationconcepts are in scope. The use of biopharmaceuticaltools is especially important in distinguishing amongstrategies with the goal being the simplest approachcapable of delivering the API of interest by the desi-gnated route. These decision trees include filters tohelp the pharmaceutical scientists based on data-dri-ven guidelines. In this section, both in silico tools aswell as 96-well plate technology will be included.

The last module of the course is dedicated to at-scaletranslation of information garnered from both prefor-mulation and formulation decision tree assessments.That is, how data associated with the design spaceassociated with API properties, pharmaceutical inputsand biopharmaceutical characterization is use todevelop robust and bioavailable dosage forms. Inaddition, the importance and selection of excipientsin this context is also assessed. These principles arehighlighted with case studies and real-world pharma-ceutical examples wherein both simple and complexdosage forms are reviewed.

Chairmen and speaker:

Guy Van den Mooter Geert VerreckUniversity of Leuven Janssen R&D Leuven, Belgium Beerse, Belgium

Programme

Wednesday, 06 May 2015, 11:00 to 18:00

Basic preformulation

- Solubility- Ionization- Log p- Solid state characterization- Powder properties- DSC, XRD, FTIR, Raman- Permeability

Thursday, 07 May 2015, 09:00 to 15:00

Applied preformulation and at-scale translation

- Automated screening:

- Super saturation- Solid dispersions- Powder rheology

- Scale up, real time and real scale examples of applying preformulation data in conventional andenabling technology development

Panel discussion

Programme is subject to change

Research & Development

Location Ibis Expo-Atomium Brussels Romeinse steenweg 5721853 BrusselsBelgiumPhone: +32 2 4610021Fax: +32 2 4610484

I herewith repealable authoriseAPV to use my E-mail address tosend me APV relevant materialincluding current programmeinformation. My acceptance canbe cancelled at any time in wri-ting

DateCourse no. 6586from 06 May 2015 11:00to 07 May 2015 15:00

Registration feeAPV member 1160 EURNon-member 1290 EUR(free of VAT according to § 4,22UStG)Coffee breaks, luncheons, din-ner and electronical proceedingsincluded.

RegistrationAPV-GeschäftsstelleKurfürstenstraße 5955118 Mainz/GermanyPhone: +49 6131 9769-0Fax: +49 6131 9769-69e-mail: apv@apv-mainz.de

You will receive a confirmationof your registration with theinvoice.

Members of authorities pay halfof the APV member’s and non-member’s registration feerespectively.

Hotel reservationIbis Expo-Atomium Brussels Romeinse steenweg 5721853 BrusselsBelgiumPhone: +32 2 4610021Fax: +32 2 4610484

Participants should make theirown hotel reservation referringto the APV seminar.

Deadline for special conferencerate: 05 April 2015.

Special rate: Single room incl. breakfast buf-fet from 89 EUR per night.

Mainz, March 2015

Registration by fax +49 6131 9769-69MAKING SCIENCE WORK

RegistrationAs soon as you have found a seminar of your inte-rest, it is very easy to register for it via fax, e-mailor online. We will process your registrationpromptly and certainly are available for any questi-ons that may arise.

Registration confirmationAfter your registration was successfully processed,you will receive a confirmation.

Before the eventA few days before the event starts, you will recei-ve important information about the seminar, suchas time, date, addresses etc.

After the eventYou will receive a certificate confirming your parti-cipation. Furthermore, we would like to ask you tofill-in our evaluation sheet to make sure we getbetter every time.

Follow-upAfter the event, we are open to receive any sugge-stions and critique that might arise during theseminar and will certainly help you with furtherquestions you may have.

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Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V.Gemeinnütziger wissenschaftlicher VereinInternational Association for Pharmaceutical Technology

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APV-GeschäftsstelleKurfürstenstraße 5955118 Mainz/GermanyPhone: +49 6131 9769-0Fax: +49 6131 9769-69e-mail: apv@apv-mainz.de

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