Journal of Pharmaceutical Care & Health Systems
Open Access

Department of Biological and Pharmacological Sciences, University of Camerino, Tirana, Albania

Publications

• Review Article   
  Importance of Information on Excipients with a Known Action or Effect in the Package Leaflet and an Oversight of the Situation in Albania
  Author(s): Irisi Sukaj**
  
  Pharmaceutical dosage forms incorporate both Active Pharmaceutical Ingredients (APIs) and excipients, which aid in formulation and manufacturing processes. Excipients, often perceived as inert, can possess pharmacological effects or trigger adverse reactions, necessitating their declaration on medicine labels and package leaflets to ensure safe use. This review focuses on commonly used excipients in orally administered pharmaceuticals, highlighting their characteristics and potential adverse effects, particularly significant for over-the-counter medications where patient self-administration is common. In the European Union (EU), regulations under Directive 2001/83/EC mandate the disclosure of excipients with known actions or effects on medicine labels and package leaflets. Conversely, Albania's regulatory framework, while aligning partially with EU directives, lacks spec.. View More»
  

  Abstract PDF