Certified lab for compounded medicines
We formulate medication for the individual needs of patients.
What we do
A compounded medicine is an unlicensed pharmaceutical preparation specifically mixed and prepared in pharmacies for the unique needs of patients.
Compounded medicine not listed in a Pharmacopoeia or a National Formulary:
Medicines are prepared in the lab based on a doctor’s prescription for a specific patient.
Medicine listed in A Pharmacopoeia or a National Formulary
Medicines are prepared in the pharmacy according to the instructions of Pharmacopoeia or a National Formulary and are to be administered directly to pharmacy patients.
The optimum formulation is searched through documented literature and established international databases so that no incompatibility arises and the final preparation is safe and effective.
Compounded medicines are prepared:
- To individualize the medication dosage in some treatments that require it, e.g., hormone replacement treatments, chemotherapy, pain management, etc.
- To address shortages of licensed medicines on the market.
- As alternative forms of drug administration when available, licensed medications don’t have the desired forms and concentrations (conversion of a pill into a syrup due to the need to change the active ingredient concentration), do not have desirable organoleptic characteristics (taste, smell) or there are allergies to their excipients.
- To give access to orphan drugs, i.e., drugs that have ceased to be marketed for reasons of economy of scale.
- To address the need for complex preparations with short-term stability that cannot be standardized for large-scale production; or preparations with a combination of active substances for better adherence or more effective action.
- When an active pharmaceutical ingredient has a well-established therapeutical value, but a licensed medicine is not yet available.
- According to Pharmacopoeial monographs for herbal and homeopathic medicines.
To harmonize the quality and safety standards of pharmaceutical preparations between European countries, the Committee of Ministers of the Council of Europe adopted the Community Resolution CM/Res (2016)1 on quality and safety management requirements for medicinal products prepared in pharmacies for the special needs of patients.
The Resolution specifies that pharmaceutical preparations are divided into two categories according to the risk assessment, “High Risk” and “Low Risk” preparations. For the first category, it recommends the application of the GMP (Good Manufacturing Practices) standard as applied in the pharmaceutical industry, while for the second category the application of the PIC/S GPP (Good Preparation Practices) standard.
Our laboratory, considering of primary importance its harmonization with modern quality and safety requirements, has been certified for the Management System according to the Resolution CM/Res (2016)1 through TUV AUSTRIA HELLAS since 3/2018, and will be in continuous compliance with the current developments, as shaped by the state and European legislation.
Under its present structure, our laboratory prepares medication not classified as high risk and for which the application of the GMP standard is not recommended, respecting the difficulties in the certification of this standard until the harmonization of the state legislation with the EU Resolution.
Indicative categories of pharma technical operations carried out in the laboratory:
- Αdjustment and personalization of the dosage and the form: Preparation of suspensions, syrups, oral solutions, monodoses in the form of tablets, capsules, and chewable troches from active pharmaceutical ingredients or licensed medicines.
- Preparation of topical medication suitable for cutaneous use or for use on mucous membranes: Creams, ointments, emulsions, aqueous gels, non-aqueous gels, solutions, nebulizations, lotions, and shampoos.
- Preparation of preparations for use in stomatology: Oral gels and ointments, suspensions, solutions, and chewable troches.
Indicative fields with wide use of compounded medicinal products:
Pediatrics, geriatrics, dermatology, stomatology, dentistry, pain management, hormone replacement therapies (HRT), chemotherapy, veterinary medicine, homeopathy.