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The Pharmaceutical Journal
Vol 271 No 7272 p578
25 October 2003

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Letters

  Concordance
  Tritace
  Modernisation
  The Charter
  Specials
  Automation
  Remuneration
  The Profession


Letters to the Editor

Tritace

Why the change from capsules to tablets?

From Mr H. Argomandkhah, MRPharmS

May I ask a simple question of Aventis Pharma, manufacturer of Tritace capsules, and the licensing authorities? I received a telephone call recently to tell me that from November 2003 Aventis Pharma will be withdrawing the capsule variant of Tritace and replacing it with tablets. All general practitioners are being advised of this and will be receiving free programmes to switch their patients from capsules to tablets. What other reason can be given for the switch other than the ending of the patent?

I have also been informed by one major generics manufacturers that it is about to launch ramipril capsules, presumably much cheaper and saving the National Health Service a great deal of money.

One wonders what importance patients and their safety have played in the decision? Switching from easily recognisable capsules in differing colours to an unfamiliar tablet form will put many patients at risk, because doctors, pharmacists, nurses, patients and carers could fail to recognise a wrong dosage. The potential for errors is huge because the dosage form covers an eight-fold increase from 1.25mg to 10mg.

I plead with both manufacturers and prescribers to keep the capsule format until the generic variants are available, and thus to put patient safety rather than profit first on the agenda.

Hassan Argomandkhah
Liverpool

 

Dr MARTIN FORD, medical director, Aventis Pharma, replies:

We are grateful for the opportunity to address the concerns that Mr Argomandkhah raises.

Turning to the most important issue first, namely, that of patient safety, we are totally confident that patient safety will not be compromised in any way by the change to the presentation of Tritace from capsules to tablets for the following reasons. First, the two presentations are bioequivalent and so they perform in the same pharmacokinetic and therefore pharmacodynamic manner. Secondly, as generic products almost always have physical characteristics that are different from the branded product they copy, we are confident that patients will adapt to this change in presentation in the same way as they do when they are dispensed generic solid dosage form pharmaceuticals. Thirdly, as the product is presented in original packs with artwork and information enclosures licensed by the Medicines and Healthcare products Regulatory Agency, we are certain that pharmacists will not be confused during normal good dispensing practice.

Concerning the questions and comments regarding why we have initiated this change, quite simply, the transition from Tritace capsules to tablets is happening due to global manufacturing rationalisation within Aventis. The United Kingdom is one of few countries that sell capsules. As a result of a worldwide initiative to streamline our manufacturing operations it is more economical to produce tablets. Importantly, with the loss of patent next year in the UK and the considerable drop in forecast volumes, the economic sense of switching to tablets becomes overwhelming.

Finally, we know that there will be several generic presentations on the market from the beginning of 2004, thus ensuring strong price competition to the considerable benefit of the NHS.

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