eksipiente

An eksipiente, commonly known in English as an excipient, is an inert substance formulated alongside the active pharmaceutical ingredient (API) in a medication or other dosage form. Excipients do not have therapeutic activity themselves but support the administration, stability, delivery, and usability of the API. They influence properties such as solubility, viscosity, taste, appearance, and shelf life, and can affect the rate and extent of drug release.

Excipients are categorized by function. Diluents or fillers (eg, lactose, microcrystalline cellulose) provide bulk for tablet formation. Binders (starch, povidone) help hold ingredients together. Disintegrants (crospovidone, croscarmellose) promote breakup of the tablet in the digestive tract. Lubricants (magnesium stearate) improve manufacturing flow. Coatings and film formers (hypromellose) mask taste and protect the API. Vehicles (water, glycerol) and emulsifiers, stabilizers, sweeteners, flavors, and colorants adjust taste and appearance.

Regulatory and quality aspects: excipients are subject to pharmacopeial specifications and quality control, with suppliers required to meet GMP standards. They must be chemically compatible with the API and stable under expected storage conditions. During development, compatibility studies assess potential interactions. Batch records, identity testing, impurity profiles, and microbiological limits help ensure safety and consistency.

Safety and selection considerations: while generally inert, some excipients can pose risks for certain patients (eg, lactose intolerance, gluten sensitivity) or cause allergies. The choice of excipient balances manufacturability, patient experience, regulatory status, and supply reliability. Excipients are also used in cosmetics and food products as carriers, stabilizers, or texture modifiers, highlighting their broad role in pharmaceutical and consumer products.