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Idria Dimichele, our resident Medicines Information Pharmacist

29.04.2016

Quick five-step guide to formulations

With the growing demand for pharmacies to take a clinical role, we understand the challenges on time to research the right medication to meet patient need. Idria Dimichele, our resident Medicines Information Pharmacist is on hand to answer your most common questions around unlicensed formulations and offers guidance to help you make the right decisions.

1. Why are special formulations necessary?

An unlicensed special formulation may be prescribed when a licensed formulation that suits the patient's needs is not available on the market. Here are some scenarios to consider:

  • A reduced strength of active ingredient or an alternative flavour is needed for children or babies.
  • A tablet product may be needed in liquid, dispersible or orodispersible form because the patient has difficulty swallowing.
  • The patient is intolerant to an ingredient in the licensed formulation, such as lactose, preservatives or a colouring agent and a bespoke formulation is needed to omit it.
  • The Consultant or GP prescribes a combination of active ingredients that are not on the market. This occurs often with topical formulations.
  • The patient has special dietary requirements, for instance Halal or Kosher.

2. Can you split bespoke tablets?

Score lines typically show whether the product is suitable for cutting into a smaller dosage. Where score lines are not present, we will advise whether the tablet can be split. However, this isn't always possible or recommended. For instance, when there is only a small amount of active ingredient or where there is a risk of incorrect dosing from inaccurate cutting.

3. Can a bespoke medicine be made available in different strengths?

Yes. Some products, such as Sodium Chloride solution, can be manufactured using differing units of measure. For example, 1mmol/1ml equals 5.844%, which equals 292.2mg/5ml.

4. Are formulations available for those with low intolerance to preservatives?

Preservative-free options may be available. However, they may have a shorter shelf-life due to the absence of preservatives in the formula.

5. Do bespoke formulations come with supporting documentation for quality checks?

When possible, we will supply English SPCs (Summaries of Product Characteristics) or PILs (Patient Information Leaflet) with unlicensed products. Where products originate from non-English speaking countries, we will provide a translated version if available.

Do you have a formulation query?

We're here to help! Simply call our expert Customer Services team on
08000 439 372 from 8am to 10pm, Mondays to Thursdays or 8am until 6pm on Fridays.*

*Times may vary during Bank Holidays.