This document provides an introduction to pharmaceutical technology. It defines pharmaceutical technology as the application of scientific knowledge and techniques to transform active pharmaceutical ingredients (APIs) into effective medicines for patients. The document outlines the basic operations, formulation, intermediate and final dosage forms used in pharmaceutical technology. It also discusses important aspects to consider like physicochemical properties, dose, administration route, and storage conditions. Finally, it provides an overview of traditional and advanced drug delivery systems (DDS).

1. Pharmaceutical Technology
Introduction
Juan M. Irache
Dep. Farmacia y Tecnología Farmacéutica
Farmacia y Tecnología Farmacéutica
Universidad de Navarra

2. Pharmaceutics (Farmacia Galénica)
• Pharmaceutics is the discipline of pharmacy that deals
with the process of turning an API and effectively by
patients.
– Biopharmacy and PKs
– Pharmaceutical Technology
• Pharmaceutical Technology: The application of scientific
knowledge or technology to pharmacy, pharmacology, and
the pharmaceutical industry. It includes methods,
techniques, and instrumentation in the manufacture,
preparation, compounding, dispensing, packaging, and
storing of drugs and other preparations used in diagnostic
and determinative procedures and in the treatment of
patients.
Farmacia y Tecnología Farmacéutica
Universidad de Navarra

3. Pharmaceutical Technology
• Pharmaceutical dosage forms:
– Basic operations (methods, techniques): milling, blending,
drying, lyophilization, etc.
– Formulation: API, excipients
– Intermediate pharmaceutical systems: podwers, emulsions,
suspensions
– Dosage forms: capsules, tablets, parenterals
– Packaging
• Aspects to consider:
– Physico-chemical properties of APIs and excipients
– Dose
– Manufacture procedure
– Administration route
– Conditioning material and storage conditions
Farmacia y Tecnología Farmacéutica
Universidad de Navarra

4. Medicines
• “Innovative” (Brand-name drug): small-molecule
• Generic: equivalent to a brand-name product in dosage,
strength, route of administration, quality, performance, and
intended use. They are identical to their brand-name
counterpart with respect to PK and PD properties.
• Biopharmaceuticals (Biologics): drugs produced using
biotechnology. They may include vaccines, blood, blood
components, allergenics, somatic cells, gene therapies,
tissues, recombinant therapeutic protein, and living cells.
• Biosimilars: medicine that is similar to another biological
one that has already been authorised for use. The company
has to demonstrate that the medicine does not have any
meaningful differences from the reference in terms of
quality, safety or efficacy.
Farmacia y Tecnología Farmacéutica
Universidad de Navarra

5. PATIENTMEDICINE
API Excipients
Conditioning
material
Unit
operations
Pharmaceutical dosage form
Dose
Route of administration
Potential incompatibilities
Clinical need
PATIENT
Farmacia y Tecnología Farmacéutica
Universidad de Navarra

6. Pharmaceutical dosage form (traditional)
Farmacia y Tecnología Farmacéutica
Universidad de Navarra
Physico-chemical
properties
Lipophilicity
Ionization
Stability
Pharmacokinetics
properties
Pharmacological
properties
Absorption
Distribution
Elimination
Other effects
Toxicity
Pharmacological
effect
Release
Absorption
Distribution
Metabolism
Excretion

7. Pharmaceutical dosage form (DDS)
Farmacia y Tecnología Farmacéutica
Universidad de Navarra
Physico-chemical
properties
Carrier
Polymer
Targeting
Pharmacokinetics
properties
Pharmacological
properties
Absorption
Distribution
Elimination
Other effects
Toxicity
Pharmacological
effect
Release
Absorption
Distribution
Metabolism
Excretion

8. References
• Vila Jato JL. Tecnología Farmacéutica. Vol. I y II. Ed. Síntesis.
1997.
• Le Hir A, Chaumeil JC, Brossard D. Pharmacie galénique : bonnes
pratiques de fabrication des médicaments. Éditions Masson, 9e ed.
2009.
• Wehrlé P, Pharmacie galénique : Formulation et technologie
pharmaceutique. Éditions Maloine. 2007.
• Lozano MC, Córdoba D, Córdoba M. Manual de Tecnología
Farmacéutica. Editorial Elsevier. Barcelona
• Aulton's Pharmaceutics, 4th Edition. The Design and Manufacture of
Medicines. Editor: Kevin Taylor
• European Medicines Agency.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics
/document_listing/document_listing_000318.jsp
Farmacia y Tecnología Farmacéutica
Universidad de Navarra