47971 - Technological Checks of Medicines

Learning outcomes

The technological characteristics of a pharmaceutical form strongly affect the performance of a medicine. The technological controls are therefore very important not only for regulatory requirements to asses the Safety, Efficacy and Quality of a medicine, but also during the development phase of a new pharmaceutical form.

The objectives of this course are:

- to understand the influence of the technological properties on the bioavailability of the drug;

- to identify the critical properties affecting the bioavailability;

- to provide the knowledge of physical and technological tests used to control the starting materials (drugs and excipients), the intemediate and the final drug product according to regulatory requirements.

Course contents

1) General overview of the European Union pharmaceutical legislation concerning medicinal products for human use (Good Manufacturing Practice, procedures for Marketing authorisation, the Common Technical Document).

2) Controls on starting materials

-Solid state properties of drugs and excipients (crystalline and amorphous forms, habit, polymorphs and pseudopolymorphs) and techniques for characterising the solid state: thermal analysis (in particular Differential Scanning Calorimetry) and  X-ray diffraction.

- Particulate and bulk properties (particle size, density, flowability, wettability and specific surface area) and relating control tests.

3) Controls on the final drug product (medicine):

 - Solid dosage forms (granules, tablets, capsules): uniformity of mass, uniformity of content, resistance to crushing of tablets, friability of tablets, disintegration test, dissolution tests.

-    Liquid dosage forms (solutions, emulsions, suspensions): uniformity of mass, uniformity of content, dose and uniformity of dose, deliverable mass or volume, organoleptic characteristics, pH.

-    Semi-solid dosage forms for cutaneous application (ointments, creams, gels and pastes): uniformity of mass, uniformity of content, deliverable mass or volume, organoleptic characteristics, consistency, viscosity, release tests.

-   Suppositories and pessaries: uniformity of mass, uniformity of content, softening time determination, resistance to rupture, disintegration test, dissolution tests.

- Parental preparations : extractable volume, particulate contamination, pH.

- Preparation for inhalation: uniformity of delivered dose, number of deliveries, aerodynamic assessment of fine particles.

4) Stability studies

Stability of a drug product, ICH/CPMP guidelines for stability tests (long-term, accelerated and stress studies).

Readings/Bibliography

P. Colombo et al., Principi di tecnologie farmaceutiche. Casa Editrice Ambrosiana, 2004.

European Pharmacopoeia 6th Ed.

Course notes.

Teaching methods

The course is organized as following:

16 hours of theory and 12 hours of practical class.

Assessment methods

Oral examination

Office hours

See the website of Nadia Passerini