Quality by Design Approach for the Development of Liposome Carrying Ghrelin for Intranasal Administration

Autor(es):Mostrar menos -

de Barros, Cecilia ^[1] ; Aranha, Norberto ^[2] ; Severino, Patricia ^[3] ; Souto, Eliana B. ^[4] ; Zielinska, Aleksandra ^[5] ; Lopes, Andre ^[6] ; Rios, Alessandra ^[1] ; Batain, Fernando ^[1] ; Crescencio, Kessi ^[1] ; Chaud, Marco ^{[1, 2, 7]} ; Alves, Thais ^{[1, 8]}

Afiliação do(s) autor(es)

^[1] Univ Sorocaba, Lab Biomat & Nanotechnol LaBNUS, BR-18078005 Sorocaba, SP - Brazil

^[2] Univ Sorocaba, Technol & Environm Proc, BR-18078005 Sorocaba, SP - Brazil

^[3] Inst Technol & Res ITP, Nanomed & Nanotechnol Lab LNMed, Av Murilo Dantas 300, BR-49010390 Aracaju, Sergipe - Brazil

^[4] Univ Coimbra, Fac Pharm, Dept Pharmaceut Technol, Ciencias Saude, P-3000548 Coimbra - Portugal

^[5] Polish Acad Sci, Inst Human Genet, Strzeszynska 32, PL-60479 Poznan - Poland

^[6] Univ Estadual Campinas, Fac Pharmaceut Sci, BR-13083871 Campinas, SP - Brazil

^[7] Univ Sorocaba, Coll Bioproc & Biotechnol Engn, BR-18023000 Sorocaba, SP - Brazil

^[8] Technol Innovat Agcy Sorocaba, Sorocaba Technol Pk, Itavuvu Ave, BR-18078005 Sorocaba, SP - Brazil

• Tipo de documento: Artigo Científico
• Fonte: PHARMACEUTICS; v. 13, n. 5 MAY 2021.
• Citações Web of Science: 1

Resumo

The therapeutic use of peptides has increasingly recognized in the development of new therapies. However, the susceptible enzymatic cleavage is a barrier that needs to overcome. Nose-to-brain delivery associated with liposomes can protect peptides against biodegradation and improve the accessibility to brain targets. The aim was to develop a liposomal formulation as ghrelin carrier. The quality by design (QbD) approach was used as a strategy for method development. The initial risk assessments were carried out using a fishbone diagram. A screening design study was performed for the critical material attributes/critical process parameters (CMAs/CPPs) on critical quality attributes (CQAs). Liposomes were obtained by hydrating phospholipid films, followed by extrusion or homogenization, and coated with chitosan. The optimized liposome formulation was produced by high-pressure homogenization coated with chitosan, and the resulted were liposomes size 72.25 +/- 1.46 nm, PDI of 0.300 +/- 0.027, the zeta potential of 50.3 +/- 1.46 mV, and encapsulation efficiency of 53.2%. Moreover, chitosan coating improved performance in ex vivo permeation and mucoadhesion analyzes when compared to the uncoated liposome. In this context, chitosan coating is essential for the performance of the formulations in the ex vivo permeation and mucoadhesion analyzes. The intranasal administration of ghrelin liposomes coated with chitosan offers an innovative opportunity to treat cachexia. (AU)

• Processo FAPESP: 18/10799-0 - Terapia combinatória utilizando polimerossomos decorados com transferrina e incorporados em hidrogéis de quitosana como smart drug delivery systems para células tumorais de melanoma
• Beneficiário: André Moreni Lopes
• Modalidade de apoio: Bolsas no Brasil - Jovens Pesquisadores
• Processo FAPESP: 17/10789-1 - Terapia combinatória utilizando polimerossomos decorados com transferrina e incorporados em hidrogéis de quitosana como smart drug delivery systems para células tumorais de melanoma
• Beneficiário: André Moreni Lopes
• Modalidade de apoio: Auxílio à Pesquisa - Jovens Pesquisadores