Journal of the Korean Society of Food Science and Nutrition (한국식품영양과학회지)

The Korean Society of Food Science and Nutrition (한국식품영양과학회)
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Quality Properties of Enteric-Coated Soft Capsule Using PEG as a Plasticizer

PEG를 가소제로 사용한 장용성 연질캡슐의 코팅 품질 특성

  • Received : 2014.08.29
  • Accepted : 2015.01.09
  • Published : 2015.02.28
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Abstract

We investigated the applicability of polyethylene glycol (PEG) as a plasticizer in enteric-coated soft capsules based on determination of quality characteristics according to molecular weight and concentration of enteric-coating PEG solution. There was no difference according to molecular weight of PEG, whereas a low PEG concentration in the enteric-coating solution was associated with higher whiteness index and slower disintegration time in pH 6.8 media. Brittleness was observed in the coating film at seam areas in 5% PEG enteric-coating solution after 2 weeks of storage at room temperature. The enteric-coating properties of PEG were compared with those of acetylated monoglyceride (AMG) and triacetin, which are enteric-coating plasticizers. Enteric-coated soft capsule containing PEG as a plasticizer showed a lower whiteness index and faster dissolution profile than AMG and triacetin. Moreover, enteric-coated soft capsule containing AMG and triacetin as plasticizers showed coating film brittleness at seam areas after 2 months of accelerated storage [$40^{\circ}C$, relative humidity (RH) 75%] but no difference at room temperature storage ($25^{\circ}C$, RH 60%). The present study suggests that concentration of PEG is important to determine enteric-coating quality, regardless of the molecular weight of PEG. In conclusion, PEG has potential as a plasticizer due to its transparency and storage stability in enteric-coated soft capsules.

본 연구에서는 장용성 연질캡슐 코팅가소제로서 PEG(polyethylene glycol)의 활용가능성에 대하여 알아보고자 PEG의 분자량 및 첨가 농도에 따른 코팅 품질을 확인하였으며, 기존에 보고된 가소제인 AMG(acetylated monoglyceride)와 triacetin을 사용하여 코팅된 장용성 연질캡슐의 품질 특성을 비교하였다. PEG 분자량(400, 4,000, 6,000)에 따른 코팅 품질에는 큰 차이가 없었으나 PEG 첨가 농도의 경우 고형분 대비 5% PEG를 사용한 코팅에서는 연질캡슐 피막 접착부에서 코팅 필름 갈라짐이 발생하였으며, PEG 첨가량이 낮을수록 인공장액에서의 붕해시간이 연장되고 백색도가 증가하는 결과를 나타내었다. 용출시험에서 용출의 초기 구간(30~90분)에서는 PEG의 용출 속도가 상대적으로 빠른 모습을 나타내었으며, PEG, AMG 및 triacetin 간의 유의적 차이가 일부 시점에서 관찰되었으나 전체적인 용출 양상은 큰 차이를 보이지 않았다. 또한 PEG 코팅에 비해 AMG와 triacetin 코팅의 경우 백색도가 유의적으로 높았고 가속조건인 고온다습한 환경에서 2개월간 보관 후에 코팅 필름이 갈라졌으며, 붕해시험에서 부적합한 결과를 확인하였다. 결론적으로 우수한 물리 화학적 특성으로 의약품 등에 널리 사용되는 첨가제인 PEG는 장용성 연질캡슐 코팅 가소제로서 활용가능성이 충분하다고 판단하였다.

Keywords

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