Implementation of Experimental Design Methodology in the Compatibility Study of Hydrocortisone With Selected Excipients Used in Solid Dosage Forms

Ronowicz-Pilarczyk, Joanna

doi:10.31925/farmacia.2021.5.6

Cited by 1 publication

(2 citation statements)

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“…The QbD approach is mainly applied in the pharmaceutical industry for which the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have issued regulatory guidelines providing directions to integrate the principles of QbD at product development stage. However, lately, the QbD concept is being more and more used in research and development [25,32]. A QbD-assisted approach for the development of liposomes for cancer therapy have been described previously [41].…”

Section: Quality By Design (Qbd) Approachmentioning

confidence: 99%

“…Although nanocarriers such as liposomes may offer potential therapeutic benefits, their manufacturing raises certain issues such as complex preparation process, low reproducibility, high variability, mainly due to a lack of understanding of the effect of raw materials and process parameters on the product's characteristics, and inadequate regulatory guidelines related to development and characterization. The QbD approach could help get around these critical issues and gain more knowledge and understanding about the product in a rational and scientific manner [22,24,25]. The main objectives of the QbD approach are to increase manufacturing efficiency and process capability, and to reduce product variability.…”

Section: Introductionmentioning

confidence: 99%

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Quality by Design Approach for the Development of Salinomycin and Gemcitabine Combination Therapy Liposomes for Colorectal Cancer

TEFAS¹

2022

FARMACIA

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An ideal cancer treatment would eradicate all types of malignant cells, both rapidly replicating and quiescent stem-like cancer cells. Therefore, a combination of drugs capable of targeting all subtypes of cancer cells could offer a better outcome in cancer. Nano-delivery systems for combination therapy represent more secure and efficient platforms for the delivery of anticancer drugs to tumours. Nanocarrier drug development is a complex process which requires careful design and evaluation at various levels to ensure their safety and efficacy. In this sense, the Quality by Design (QbD) approach could help develop a robust, highquality nanocarrier formulation by understanding the properties of the product and the manufacturing process. In this study, the QbD approach was used in the development of liposomes co-loaded with a combination of anticancer drugs, salinomycin (SAL) and gemcitabine (GEM) for colorectal cancer therapy. While GEM is a conventional anticancer drug, SAL has shown selectivity towards cancer stem cells. The implementation of the QbD approach involved the identification of the quality target product profile (QTPP) and critical quality attributes (CQAs) of the liposomes. Based on risk analysis, the Design of Experiments (DoE) methodology was employed to evaluate the impact of critical formulation factors on the liposomes' properties, in a time and cost-effective manner, in order to obtain SAL and GEM co-loaded liposomes with desired characteristics. RezumatTratamentul ideal al cancerului implică eradicarea atât a celulelor maligne care se multiplică rapid, cât și a celulelor stem pasive. De aceea, asocierea de substanțe care țintesc toate subtipurile de celule canceroase ar putea duce la efecte superioare în terapia cancerului. Nanosistemele pentru terapia combinată reprezintă sisteme mai sigure și mai eficiente pentru transportul substanțelor anticanceroase. Dezvoltarea nanosistemelor este un proces complex care necesită atenta formulare și evaluare pentru a conferi acestora siguranță și eficacitate. În acest sens, conceptul de Calitate prin Design (QbD) ar putea ajuta la dezvoltarea unei nanoformulări robuste și calitative prin înțelegerea proprietăților sistemelor de transport și a procesului de fabricație. În acest studiu, abordarea QbD a fost utilizată în dezvoltarea lipozomilor încărcați cu o asociere de substanțe anticanceroase, salinomicină (SAL) și gemcitabină (GEM) pentru terapia cancerului colorectal. În timp ce GEM este un agent anticanceros convențional, SAL a dovedit selectivitate față de celulele stem canceroase. Implementarea conceptului QbD a presupus identificarea profilului de calitate (QTPP) și a atributelor critice de calitate (CQA) ale lipozomilor. Pe baza analizei de risc, a fost utilizată metodologia planurilor experimentale (DoE) pentru a evalua impactul variabilelor critice de formulare asupra proprietăților lipozomilor, într-o manieră eficientă din punctul de vedere al timpului și al costurilor, pentru obținerea lipozomilor cu SAL și GEM care să posede caracteristicile d...

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Section: Quality By Design (Qbd) Approachmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%