Allergic rhinitis (AR) is characterized by
inflammation of the nasal mucosa with
hypersensitivity resulting from seasonal or perennial responses to specific environmental
allergens and by symptoms like nasal rubbing,
sneezing,
rhinorrhea, lacrimation, nasal congestion and obstruction, and less frequently
cough. KOB extracts, which is a polyherbal medicine consisting of 5 different herbs (Atractylodes macrocephala, Astragalus membranaceus, Saposhnikovia divaricata, Ostericum koreanum and Scutellaria baicalensis) had commonly been used for the treatment of various allergic diseases showed an
anti-allergic effect by modulating mast cell-mediated allergic responses in
allergic rhinitis, recently. On the other hand,
pseudoephedrine is a
sympathomimetic amine commonly used to relieve congestion in patients with
allergic rhinitis and
common colds. Considering the KOB's therapeutic mechanism, the combination with
pseudoephedrine would be suitable for
allergic rhinitis. This study is to obtain an effective
extended release formulation using
pseudoephedrine and KOB extracts to reduce side effects of
drug due to repeated dosing and improve the compliance of patients for treatment of
rhinitis and nasal decongestion. So, the fixed-dose combination
tablet of
pseudoephedrine and KOB extracts was prepared by direct compression and characterized by
drug content, flowing characteristics and dissolution test. The
drug content of
baicalin of KOB extracts was within the range of 95-105% except for T1 formulation. The hardness and friability values of all formulations ranged from 9 to 13 kp and less than 1%, respectively. Taken together, T4 or T8 could be a stable fixed-dose combination
tablet for extended release of
pseudoephedrine and KOB extracts for nasal
rhinitis.