경구용 약물 제형의 유당 함량과 유당불내증 환자의 임상적 의의

Clinical Implication of the Lactose Contents Contained in Oral Drug Formulations for Lactose Intolerant Patients in Korea

Although lactose is also widely used as an excipient in oral formulations, the amount of ‘hidden’ lactose in drugs still has not been identified. We investigated the ‘hidden’ lactose in 1,109 oral solid formulations in formulary of a gen-eral hospital in Seoul. The investigation is conducted from Oct. 2015 to Jan. 2016. Firstly, we retrieved the 1,109 items through two databases (KIMS©, Druginfo©) to know whether lactose is contained or not. Out of 1,109 items, 501 items were lactose-containing drugs (LCDs). We confirmed the amount of lactose of 228 items by mailing from each manufactures of LCDs. Then we calculated the ingested daily amount of lactose. The range of lactose amounts on each LCD was 7.4-601.4 mg. The average amount of lactose per formulation was as follows; 93.4(7.4−383.1) mg for tablets, 91.8(8.3−187.3) mg for capsules, 344.9(88.4−601.4) mg for granules, and 175.0 mg for powder. When LCD was taken usual dosage, the ingested maximum lactose per day was 1,804.3 mg, and 500 mg or more (504.0−1,804.3) for six items, and less than 300 mg for remaining 222 items. This result suggests that clinical symptoms of lactose intolerance may not induce by one LCD, but may occur by combination therapy with various LCDs. Therefore, if the patient shows symptoms of lactose intolerance after taking the drug, it is also necessary to check that the drug contains lactose or to replace with LFD. And the man-ufacturer should provide accurate information about the lactose content, and also do well to apply alternative excipient besides lactose in the manufacture.