Apuaineet

Apuaineet, or excipients, are substances added to a pharmaceutical formulation alongside the active ingredient. They do not produce therapeutic effects themselves but serve to facilitate manufacturing, dosage form, stability, taste masking, appearance, and patient acceptability. They may also influence the release and absorption of the active ingredient and can affect shelf life and storage.

Common categories include binders (povidone, microcrystalline cellulose) that help tablet formation; fillers or diluents (lactose, cellulose) to achieve the desired size; disintegrants (sodium starch glycolate) that aid tablet break-up; lubricants (magnesium stearate) to reduce friction during production; coatings (hydroxypropyl methylcellulose) that control release or mask taste; and additives such as colorants, sweeteners, flavorings, antioxidants, and preservatives.

Selection and quality: Excipients are chosen for safety, compatibility with the API and other ingredients, stability under processing and storage, and manufacturability. They must meet pharmacopeial specifications (USP-NF, EP) and are produced under good manufacturing practice. While generally safe, excipients can cause adverse reactions in sensitive individuals and may require allergen labeling (for example lactose, certain gluten-containing materials, or peanut derivatives in rare cases).

Regulatory context: In the EU and Finland, apuaineet are regulated as inactive ingredients in medicines. Documentation on excipients is part of product dossiers, with oversight by national authorities such as Fimea and alignment with international pharmacopeial standards and ICH guidelines.