禾生技 老藥新劑型(5-aminosalicylic acid + HA) 攻IBD !

禾生技旗下新藥取得經濟部經費補助 今富族網記者吳泓駿／報導 2014-11-03 禾伸堂生技（禾生技；4191）日前向經濟部申請A+企業創新研發淬鍊計畫－快速審查臨床試驗計畫（Fast Track）的結果出爐，公司旗下「發炎性腸道疾病新複方IBD98-M新藥PhaseI臨床試驗計畫」於上週四（10/30）獲經濟部審查通過並核定補助經費。公司表示，「IBD98-M」主要針對發炎性腸道疾病所開發的新複方新藥，已在今年向美國FDA申請Phase I臨床試驗審查。此外，「快速審查臨床試驗計畫」全程開發期共15個月，總經費將斥資新台幣1,601萬元，其中由政府補助經費新台幣560萬元，此補助款將有助於計劃中各項試驗的推展。禾生技隸屬於上市公司禾伸堂企業（3026）旗下，致力於經營醫療器材的研發與批發，以及炎性腸道疾病西藥的研發與授權。公司透過「透明質酸藥物傳輸技術平台」，以透明質酸作為傳輸載體，發展新劑型及新複方，這次獲得經費補助的IBD98-M新藥便是在此平台所推出的第一項新藥。IBD98-M，為本公司利用自有開發的HDD(Hyaluronan Drug Delivery) Technology平台，以透明質酸(hyaluronic acid)與5-aminosalicylic acid (5-ASA)藥物為基礎原料，所開發之新劑型/新複方新藥(new combination drug)。

PASER® GRANULES (Jacobus)(aminosalicylic acid granules)PASER (aminosalicylic acid) granules are a delayed release granule preparation of aminosalicylic acid (p-aminosalicylic acid: 4-aminosalicylic acid) for use with other anti-tuberculosis drugs for the treatment of all forms of active tuberculosis due to susceptible strains of tubercle bacilli. The granules are designed for gradual release to avoid high peak levels not useful (and perhaps toxic) with bacteriostatic drugs. Aminosalicylic acid is rapidly degraded in acid media; the protective acid-resistant outer coating is rapidly dissolved in neutral media so a mildly acidic food such as orange, apple or tomato juice, yogurt or apple sauce should be used. Aminosalicylic acid (p-aminosalicylic acid) is 4-Amino-2-hydroxybenzoic acid. PASER granules are the free base of aminosalicylic acid and do NOT contain sodium or a sugar. The molecular formula is C 7 H 7 NO 3 with a molecular weight of 153.14. With heat p-aminosalicylic acid is decarboxylated to produce CO 2 and m-aminophenol. If the airtight packets are swollen, storage has been improper. DO NOT USE if packets are swollen or the granules have lost their tan color and are dark brown or purple. PASAR granules are supplied as off-white tan colored granules with an average diameter of 1.5 mm and an average content of 60% aminosalicylic acid by weight. The acid resistant outer coating will be completely removed by a few minutes at a neutral pH. The inert ingredients are:/colloidal silicon dioxide/dibutyl sebacate/hydroxypropyl methyl cellulose/methacrylic acid copolymer/microcystalline cellulose/talc   The packets contain 4 grams of aminosalicylic acid for oral administration three times a day by sprinkling an apple sauce or yogurt to be eaten without chewing. Suspension in an acidic fruit drink such as orange juice or tomato juice will protect the coating for at least 2 hours. Swirling the juice in the glass will help resuspend the granules if they sink.