introduction 2017

Pharmaceutical TechnologyIntroduction

Juan M. IracheDep. Farmacia y Tecnología Farmacéutica

Farmacia y Tecnología FarmacéuticaUniversidad de Navarra

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.


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


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.


PATIENTMEDICINE

API Excipients

Conditioningmaterial

Unit operations

Pharmaceutical dosage form

DoseRoute of administrationPotential incompatibilitiesClinical needPATIENT


Pharmaceutical dosage form (traditional)


Physico-chemicalproperties

LipophilicityIonizationStability

Pharmacokineticsproperties

Pharmacologicalproperties Absorption

Distribution

Elimination

Other effectsToxicity

Pharmacologicaleffect

ReleaseAbsorptionDistributionMetabolismExcretion

Pharmaceutical dosage form (DDS)


Physico-chemicalproperties

CarrierPolymerTargeting

Pharmacokineticsproperties

Pharmacologicalproperties Absorption

Distribution

Elimination

Other effectsToxicity

Pharmacologicaleffect

ReleaseAbsorptionDistributionMetabolismExcretion

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


introduction 2017

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