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Asian Journal of Biomedical and Pharmaceutical Sciences | Volume 8

May 14-15, 2018 | Montreal, Canada

Global Summit on

Biopharma & Biotherapeutics

rally inhaled drug products (OIPs), such as corticosteroids

and bronchodilators are most widely used for the

treatment of respiratory diseases, such as asthma and

chronic obstructive pulmonary disease (COPD). Salmeterol/

fluticasone propionate is a fixed-dose combination

inhalation agent containing a long-acting b2-adrenoceptor

agonist (LABA) plus a corticosteroid and is known to be

effective and well accepted in the treatment of asthma and

COPD. Introducing generics of these products is essential

as the pricing of these medications remains a barrier to

adequate patient care. Establishing bioequivalence of OIPs

is very challenging. Study procedures and bioequivalence

requirements of OIPs in US, Canada and Europe will be

discussed in this presentation. Four pharmacokinetic

studies were conducted in healthy volunteers to determine

bioequivalence of test and the reference formulations of

salmeterol xinafoate/fluticasone propionate HFA pMDI, two

with the higher strength (25/250mcg per actuation) and two

with the lower strength (25/125mcg per actuation). All the

studies were single dose, randomized, crossover studies

with a minimum washout period of 14 days. Two of the four

studies (for each strength) also compared the pulmonary

deposition by blocking gastrointestinal absorption (GI) using

charcoal blockade. Since the 90% CI for Cmax and AUC0-t

for both salmeterol and fluticasone were within the 80–

125% interval in all the studies, it was concluded that test

and the reference formulations of salmeterol xinafoate/

fluticasone propionate HFA pMDI were bioequivalent with

and without charcoal blockade for both the strengths as per

EMA guidelines.

Challenges and bioequivalence requirements of Orally Inhaled Drug Products (OIPs) - Salmeterol

xinafoate/fluticasone propionate HFA pMDI pharmacokinetic studies

Muneesh Garg

Sitec Labs Pvt. Ltd., India