초록 ▼

* 급성상기도감염 혹은 염증성 만성 기관지염 환자에서 AG NPP709 현탁액의 안전성과 유효성을 평가하기 위한 치료적 확증 목적의 임상시험을 진행함
* 천식 등 호흡기계질환 적응증 확대 가능성을 검토하고, 특장점 발굴을 위한 차별화 연구로 부가적 생리활성과 추가적 성분연구를 진행함
* 대량생산을 위한 최적 조건을 확립하고, 표준화된 최적 생산 공정을 확립함
* 원료 및 완제의약품의 안정성 평가를 위해 장기보존실험 및 추가 제형연구를 진행함
* NDA Documentation 작성과 KFDA NDA 신청을 진행

* 급성상기도감염 혹은 염증성 만성 기관지염 환자에서 AG NPP709 현탁액의 안전성과 유효성을 평가하기 위한 치료적 확증 목적의 임상시험을 진행함
* 천식 등 호흡기계질환 적응증 확대 가능성을 검토하고, 특장점 발굴을 위한 차별화 연구로 부가적 생리활성과 추가적 성분연구를 진행함
* 대량생산을 위한 최적 조건을 확립하고, 표준화된 최적 생산 공정을 확립함
* 원료 및 완제의약품의 안정성 평가를 위해 장기보존실험 및 추가 제형연구를 진행함
* NDA Documentation 작성과 KFDA NDA 신청을 진행하여 최종 승인 취득(제5013호)

Abstract ▼

1. Purpose of the R&D
Air pollution and various environmental changes due to rapid industrialization have brought increased respiratory diseases including cough and sputum and, therefore, the development of new medicine for respiratory diseases have been increasing all around the world. On the ot

1. Purpose of the R&D
Air pollution and various environmental changes due to rapid industrialization have brought increased respiratory diseases including cough and sputum and, therefore, the development of new medicine for respiratory diseases have been increasing all around the world. On the other hand, several component medicines were tend to be abused as common cold medicines with little specialized research. Moreover, several antitussive or expectorant components are being used indiscriminately as OTC drugs, although they are being used as ETC in advanced countries because of their well-known side effects. Major antitussive agents mostly having the narcotic effects, and when it comes to expectorant, indiscreet taking of numerous drugs cause a serious problems. Under these circumstances, we suggest that natural products are appropriate materials as a non-nacotic medicine which has no or relatively mild side effect. Therefore, we aimed to develop a new antitussive and expectorant agent from well known natural products.
2. R&D contents and results
* Clinical study
Clinical test was performed in patients with acute upper respiratory infection or inflammatory chronic bronchitis and the safety and efficacy of AG NPP709 was confirmed.
* Value-up study
Additional activity test and ingredient test were performed for investigating the possibility of expansion of use in respiratory disesase.
* Mass production process
The optimal condition for mass production was established based on the scale-up test condition. To maximize the efficiency in time and cost, production conditions and equipments regard were established, and the process validation was drawn up.
* Formulation test
For stability test of drug substance and drug product, long term testing and accelerated testing were performed. Also additional dosage form test such as purification was performed.
* NDA filing
Materials for drug substance and drug product approval were documented, the finished NDA documents were submitted to KFDA and the permission for new botanical drug(ETC) were obtained.
3. Plan of further study & application
* The final aim of this study is the development of a new herbal medicine with not only superior effects in antitussive and expectorant activity but also outstanding safety; and therefore, many world-widely used drugs can be superseded by this new herbal medicine. Ultimately, the development of a new herbal medicine and entry to the market in advanced countries such as Europe can be a driving force to raise our national competitiveness in the world market.
* In the process of selection of candidate plant materials, plant material data base and extract libraries were established base on the oriental medicinal information. These data base and libraries probably be useful not only to development of new herbal drugs but to st udy of natural product-originated derivatives in the future.
* This study can trigger the new herbal drug production; desire for a new drug development and production will increased and social and industrial atmosphere will be vitalized. Eventually, successful outcome of this study will highly affect to the natural product industry over-all such as cosmetics, food industry as well as pharmaceutical industry.

목차 Contents

• 최종보고서 서식 ...2
• I. 총괄현황 ...3
• 1.표지 ...4
• 2. 제출문 ...6
• 3. 보고서 요약서 ...7
• 4. 요약문 (한글) ...8
• 5. 요약문 (영문) ...10
• 6. 연구 성과 실적 및 향후 계획 ...12
• 7. 참여연구원 현황표 ...18
• II. 총괄연구과제 연구결과 ...19
• 1. 연구개발과제의 배경 및 필요성 ...20
• 2. 국내외 기술개발 현황 ...23
• 3. 연구개발과제의 추진체계 ...25
• 4. 연구개발수행 내용 및 결과 ...27
• 5. 목표달성도 및 관련분야 기여도 ...39
• 6. 향후 연구성과 추진 계획 ...40
• 7. 연구개발결과의 파급효과 ...40
• 8. 연구개발결과의 활용계획 ...41
• 9. 연구개발과정에서 수집한 해외과학기술정보 ...42
• 10. 참고문헌 ...42
• III. 첨부서류 ...44
• 목차 ...45
• 1. 자체평가의견서 ...46
• 2. 실적 증빙자료 ...50