[e-drug] Suitability of Zinc preparations

["Huma Rasheed" <leohumapk@yahoo.co.uk>]

E-DRUG: Suitability of Zinc preparations
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Dear E-druggers,

In Pakistan oral preparations of Zinc were registered very recently by two local companies. Both of the companies have launched oral solution of zinc sulphate claiming to be of low osmolarity. But the doctors using it on their patients (as especially reported by pediatric gastroenterologist of my hospital) say that the formulation has poor palatability, is costly and that the patients receiving it for other conditions than acute watery diarrhea start showing diarrhea, probably due to the formulation design on receiving these preparations. 

As far as I have experienced we at the children?s hospital have been dispensing Zinc for our patients of Wilson?s disease since more than five years as Zinc sulphate sachets (from the extemporaneous preparation service section) as the formulation of zinc was not available in the market, there was no such complaint.

Moreover the doctor has also shown concern about the efficacy of the Zn preparation available in the market. Since the WHO has added Zn supplementation for acute watery management protocol we receive increasing number of calls for Zn sachets which is very difficult for us to cope with. 

As you know that the developing countries like us not only lack in the minimal registration standards but unluckily the homework on the product in also not done well. 

Zn is available in world market primarily as Zn sulphate or Zn acetate tablets.  Tablets are stable and cheap dosage forms. Normally people form very poor communities suffer with the diarrhea and these patients are obviously in very large number hence registration authorities must have looked into it before allowing the product registration. While designing the formulation it should also be kept in mind that these tablets should not contain lactose in it as lactose intolerance is also one of the causes of diarrhea, especially in children. Moreover the preparation should not be too sugary to cause diarrhea and other problems in young children.

The absence of pharmaco vigilance, no form of post marketing surveillance and absolutely no concern in the whole process for the checking of proof of the clinical efficacy of the product result in the  scenario when a  simple pharmaceutical need of public like zinc supplement cannot be available in the market in suitable and efficacious form.

This is the very simple example of importance of issues we come across in our discussions at the e-drug forum. 

I look forward for some pharmaceutical company in Pakistan to please launch this very simple product with proper workups and request ministry to please at least consult BNF or PDR for international market survey while registering new products. (I am not very hopeful that ministry will understand my plea as this is purely a concern raised by pharmacist of a country with a booming local and multinational pharmaceutical industry but still the needs of the people are not met). 

I also wish that pharmaceutical company providing the quality dosage form of Zn apply for the registration in Pakistan at suitable price. 

Regards

Huma Nouman
Clinical Pharmacist
The Children's hospital 
Lahore
Pakistan
leohumapk@yahoo.co.uk