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AAPS PharmSciTech

, 20:14 | Cite as

Use of Risk Assessment and Plackett–Burman Design for Developing Resveratrol Spray-Dried Emulsions: a Quality-by-Design Approach

  • Pontip Benjasirimongkol
  • Suchada Piriyaprasarth
  • Kunikazu Moribe
  • Pornsak SriamornsakEmail author
Research Article
  • 85 Downloads

Abstract

In this study, the resveratrol spray-dried emulsions were developed using a quality-by-design approach. Further, the product and process factors that affected the quality of the spray-dried emulsions were analyzed and illustrated using an Ishikawa diagram. The product and process risks were prioritized using a risk-ranking system. The low methoxyl pectin (LMP) amount, caprylic/capric glyceride (CCG) amount, homogenization time, homogenization speed, inlet temperature, pump speed, drying airspeed, and de-blocking speed were observed to be the eight highest risk factors. Further, the criticality of these eight factors on the responses was determined using the Plackett–Burman design. Increasing the LMP amount increased the particle size, whereas increasing the CCG amount enhanced the drug-loading capacity and drug dissolution at 5-min intervals (Q5) and decreased the moisture content. Q5 was positively affected by the homogenization speed and pump speed; however, it was negatively affected by the LMP amount. The spraying efficiency was affected by the pump speed and the LMP amount. Further, the risk level of the homogenization time, inlet temperature, drying airspeed, and de-blocking speed were reduced. However, the LMP amount, CCG amount, homogenization speed, and pump speed were observed to remain at high risk and require further investigation. The risk assessment and Plackett–Burman design mitigated the risks and identified the critical factors that affected the quality of the resveratrol spray-dried emulsions and the spray-drying process.

KEY WORDS

quality-by-design risk assessment Plackett–Burman design resveratrol spray-dried emulsion 

Notes

Funding

The authors would like to thank the Faculty of Pharmacy, Silpakorn University, Thailand for providing partial financial support.

Compliance with Ethical Standards

Conflict of Interest

The authors report no conflict of interest. The authors alone are responsible for the content and writing of this article.

Supplementary material

12249_2018_1220_MOESM1_ESM.pdf (72 kb)
Fig. S1 (PDF 72 kb)

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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  • Pontip Benjasirimongkol
    • 1
    • 2
    • 3
  • Suchada Piriyaprasarth
    • 1
    • 2
  • Kunikazu Moribe
    • 3
  • Pornsak Sriamornsak
    • 1
    • 2
    • 4
    Email author
  1. 1.Department of Pharmaceutical Technology, Faculty of PharmacySilpakorn UniversityNakhon PathomThailand
  2. 2.Pharmaceutical Biopolymer Group (PBiG), Faculty of PharmacySilpakorn UniversityNakhon PathomThailand
  3. 3.Graduate School of Pharmaceutical SciencesChiba UniversityChibaJapan
  4. 4.Academy of ScienceRoyal Society of ThailandBangkokThailand

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