QbD guided early pharmaceutical development study: Production of lipid nanoparticles by high pressure homogenization for skin cancer treatment

AMASYA G., Aksu B., BADILLI F. U., BEŞİKCİ A., Tarimci N.

INTERNATIONAL JOURNAL OF PHARMACEUTICS, cilt.563, ss.110-121, 2019 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 563
  • Basım Tarihi: 2019
  • Doi Numarası: 10.1016/j.ijpharm.2019.03.056
  • Dergi Adı: INTERNATIONAL JOURNAL OF PHARMACEUTICS
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.110-121
  • Anahtar Kelimeler: Quality by design (QbD), Artificial neural networks, Solid lipid nanoparticles, Nanostructured lipid carriers, High pressure homogenization, 5-Fluorouracil (5-FU), Skin penetration/permeation, QUALITY-BY-DESIGN, DRUG-DELIVERY, TRANSDERMAL DELIVERY, STRATUM-CORNEUM, 5-FLUOROURACIL, FORMULATION, OPTIMIZATION, SLN, PENETRATION, CARRIERS
  • Ankara Üniversitesi Adresli: Evet

Özet

This research attempts to bring together the positive aspects of lipid nanoparticles and Quality by Design (QbD) approach for developing a novel drug delivery system for skin cancers and aktinic keratosis. Lipid nanoparticles which is one of the most efficacious options for topical treatment of skin diseases were prepared due to their ability to overcome the complex structure of skin barrier and to enhance the skin penetration. Since the formulation development contains complex variables of active ingredients, raw materials or production method; all the variables of the product should be elaborated. QbD approach which refers to design and develop formulations and manufacturing processes to maintain the prescribed product quality was also successfully adopted to achieve a time- and cost-saving process ensuring a high-quality product.