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경구용 서방성/지연성 성형제품의 허가 후 변경사항 관리를 위한 SUPAC-MR 응용
사홍기,조미현,박상애,윤미옥,강신정 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.3
The objective of this study was to scrutinize the rationale of SUPAC-MR and its application in processing postapproval changes to modified release solid oral dosage forms. The types of postapproval changes that were primarily covered with SUPAC-MR included variations in the components and composition, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. SUPAC-MR defined levels of postapproval changes that the industry might make. Classification of such categories was based on the likelihood of risk occurrence and potential impact of changes upon the safety and efficacy of approved drug products. In most cases, the changes could be classified into 3 levels. It described what chemistry, manufacturing, and control tests should be conducted for each change level. The important tests specified in SUPAC-MR were batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. It then suggested what type of a filing report should be submitted to the FDA for each change level. In general, level 1 changes could be reported in an annual report, whereas level 2 and/or 3 changes could be submitted in changes-being-effected or prior approval supplements. It could be understood that the purpose of SUPAC-MR was to maintain the safety and quality of approved modified release solid oral dosage forms undergoing certain changes. At the same time, it contributed to providing a less burdensome regulatory process with the manufacturers when they wanted to make postapproval changes. European regulatory agencies also implemented SUPAC-like regulations in handling such changes to drug products. Therefore, in this study a recommendation was made for KFDA and the Korean industry to evaluate thoroughly the usefulness of these guidances and regulations in dealing with postapproval changes to modified release solid oral dosage forms.
경구용 속방성 성형제품의 허가 후 변경사항을 다루는 SUPAC-IR에 대한 검토
사홍기,박상애,윤미옥,강신정 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.1
The objective of this study was to provide a better understanding of SUPAC-IR and its application in handling postapproval changes to immediate release solid oral dosage forms. Originally, SUPAC-IR was aimed at reducing the regulatory burdern of the industry when they were making postapproval changes, but still at maintaining the formulation quality and performance of a drug product. The postapproval changes that were covered under SUPAC-IR included variations in the components and composition of formulation, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. The guidance defined levels of changes, based on the likelihood of risk ocurrence and potential impact of postapproval changes upon the safety and efficacy of a drug product. It suggested what a type of filling report should be submitted to the FDA for each level of change. Chemistry, manufacturing, and control tests to be executed were also recommended for each change level. The important tests specified in the guidance included batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. However, there have been strong demands on revising the current SUPAC-IR in order to resolve some issues and to improve its usefulness in evaluating postapproval changes to immediate release solid oral dosage forms. In particular, the rigorous requirement of case C dissolution test and the definition of batch size were challenged by both academia and the industry. A revision work was in progress to reflect these inputs and to expand the utility of SUPAC-IR. As a result of these concerted efforts, an updated 2nd version of SPAC-IR would be likely to be issued very soon to the public.
의약품 허가 후 발생하는 변경사항에 대한 EMEA 관리 지침
사홍기 이화여자대학교 약학연구소 2008 藥學硏究論文集 Vol.- No.17
The objective of this report is to introduce the European Union's variation rules governing medicinal products that are subject to post-approval changes. The EMEA outlines a variety of changes occurring to approved medicinal products. It also recommends a marketing authorisation holder to follow specific post-approval applications in various situations. For instance, the Commission Regulation (EC) No. 1085/2003 explains variation types and suggests post-authorisation procedures with which an applicant should comply, In all cases of minor and major variations the applicant has to investigate and validate whether or not the intended changes would have impact on the safety, efficacy and quality of a drug product. The applicant should then submit to the EMEA a variation application with adequate documentation in support of the notified changes. This procedure is implemented to ensure that changes to the approved medicinal product do not cause any public health concerns. In fact, the post-authorisation guidance categorizes postapproval changes into type IA/IB variations, type II variations, and extension applications. Such classifications determine administrative procedures to be followed in an efficient manner. Based on the type of a variation, the regulatory agency opts to reduce or extend the evaluation time-Same. The thrust of the EU's post- authorisation guidance is introduced in text with appropriate explanation. All these information will be likely to be helpful in updating a Korean regulatory guidance that could better deal with post-approval changes to generic drugs available in the market.
혈장시료 중 아세메타신과 인도메타신의 HPLC 동시 분석법 개발 및생체이용률 시험에의 응용
문희경,사홍기,조애리 대한약학회 2019 약학회지 Vol.63 No.3
Acemetacin is a new potent non-steroidal anti-inflammatory compound which is used for the treatment ofarthritis and rheumatic diseases. To establish an assay condition for bioavailability study of acemetacin, high-performanceliquid chromatographic (HPLC) method using UV detection for the determination of acemetacin and its metaboliteindometacin in blood has been developed. Samples were analysed with Luna C18 column (250×4.6 mm, 5 μm, Phenomenex)which maintained at 40oC. The mobile phase was composed of 0.02M phosphate buffer (pH 4.5):methanol=45:55. Theflow rate was 1.4 mL/min. UV absorbance was monitored at 254 nm. Typical retention times were 23, 31 and 34 min forflubiprofen (internal standard), acemetacin and indometacin, respectively. Calibration curves for the determination ofacemetacin and indometacin in plasma showed a good linearity at a concentration range from 100 to 3000 ng/mL(r2=0.999). Blood samples of eight human volunteers who had received 3 tablets of 60 mg of acemetacin orally wereanalysed with HPLC and pharmacokinetic parameters were evaluated. The developed analytical method afforded a simple,rapid and sensitive assay for the measurements of acemetacin
이중유제법에 근거한 미립자 제조 공정 중 단백질의 분산매로의 전이 양상
조미현,최수경,사홍기 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.5
₃ The objective of this study was to investigate the patterns of protein leaching to an external phase during an ethyl acetate-based, double emulsion microencapsulation process. An aqueous protein solution (lactoglobulin, lysozyme, or ribonuclease; W₁) was emulsified in ethyl acetate containing poly-d,l-lactide-co-glycolide 75:25. The W₁/O emulsion was transferred to a 0.5% polyvinyl alcohol solution saturated with ethyl acetate (W₂). After the double emulsion was stirred for 5, 15, 30, or 45 min, additional 0.5% polyvinyl alcohol (W₂) was quickly added into the emulsion. This so-called quenching step helped convert emulsion microdroplets into microspheres. After 2-hr stirring, microspheres were collected and dried. The degree of protein leaching to W₂ and/or W₃ phase was monitored during the microencapsulation process. In a separate, comparative experiment, the profile of protein leaching to an external phase was investigated during the conventional methylene chloride-based microencapsulation process. When ethyl acetate was used as a dispersed solvent, proteins continued diffusing to the W₂ phase, as stirring went on. Therefore, the timing of ethyl acetate quenching played an important role in determining the degree of protein microencapsulation efficiency. For example, when quenching was peformed after 5-min stirring of the primary W₁/O emulsion, the encapsulation efficiencies of lactoglobulin and ribonuclease were 55.1 ± 4.2 and 45.3 ± 7.6%, respectively. In contrast, when quenching was carried out in 45 min, their respective encapsulation efficiencies were 39.6 ± 3.2 and 29.9 ± 11.2%. By sharp contrast, different results were attained with the methylene-chloride based process: up to 2 hr-stirring of the primary and double emulsions, less than 5% of a protein appeared in W₂. Afterwards, it started to partition from W₁ to W₂/W₃, and such a tendency was affected by the amount of PLGA75:25 used to make microspheres. Different solvent properties (e.g., water miscibility) and their effect on microsphere hardening were to be held answerable for such marked differences observed with the two microencapsulation processes.