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Formulation and evaluation of liposomes of fenofibrate prepared by thin film hydration technique.

Record Type:	Language materials, manuscript : Monograph/item
Title/Author:	Formulation and evaluation of liposomes of fenofibrate prepared by thin film hydration technique./
Author:	Amin, Shivani G.
Description:	1 online resource (150 pages)
Notes:	Source: Masters Abstracts International, Volume: 78-11.
Contained By:	Masters Abstracts International78-11.
Subject:	Pharmaceutical sciences. -
Online resource:	click for full text (PQDT)
ISBN:	9781369708226

Formulation and evaluation of liposomes of fenofibrate prepared by thin film hydration technique.
Amin, Shivani G.

Formulation and evaluation of liposomes of fenofibrate prepared by thin film hydration technique. - 1 online resource (150 pages)

Source: Masters Abstracts International, Volume: 78-11.

Thesis (M.S.)--Long Island University, The Brooklyn Center, 2017.

Includes bibliographical references

Despite the enormous amount of effort spent during the past 44 years (greater than 114,000 scientific publications) and the well-formed consensus within the scientific community about the potential of liposomes as drug carriers, currently relatively few products (12 therapeutic products) are available on the market and all of these were approved between 1995 and 2004. Several factors may have contributed to the slow pace of commercialization of liposome drug products during the last decade: 1) the difficulties associated with identifying the formulation and process design critical quality attributes of these complex systems and 2) Higher manufacturing cost due to low preparation reproducibility and low entrapment of therapeutic active agents. Hence, there is a persistent need for the design and development of these complex systems. We have used central composite design (CCD) for the optimization of the liposomal formulation. The aim is to study the impact of process variables like Hydration volume, Hydration time, Sonication time and Drug: lecithin Ratio on quality attributes like Particle size, Peak shape, Polydispersity Index, Drug loading, Entrapment efficiency and Redispersion of the complex liposomal formulation system. A central composite design, 4 factor, face centered was employed to develop the liposomal suspension and identify the critical parameters and optimize the formulation components. Seventeen liposomal formulations were prepared with variable amounts of lecithin and drug (FBT) as per the CCD face centered design and their in-vitro dissolution studies, solid state characterization were performed. The particle sizes of all liposomal suspensions were between 99.5nm to 290 nm, however depending upon process parameters they have resulted in either monomodal, bi-modal and multimodal particle size distribution along with difference in PDI values. The entrapment efficiency greater than 70% was achieved with Drug: lecithin ratio 0.1: 3.5.The dissolution studies showed enhanced dissolution of liposomal formulation in comparison to pure FBT. The particle size distribution showed direct correlation with the dissolution profile The Drug to lecithin ratio and hydration media volume has significant impact on drug entrapment capacity of the formulation and in-vitro dissolution rate. All the formulations showed zeta potential ranging from -20.1mv to -28.3mv. DSC thermograms of FBT, showed sharp endothermic peak however, the FBT loaded liposomes showed disappearance of melting peak for FBT, indicating the molecularly dispersion of FBT in liposomes and significant physical interaction between FBT and lipid components. The FTIR spectrum showed distinctive peaks for FBT which were also observed in the liposomal formulation hence, the drug had no strong interaction with lecithin chemically. The study has created a successful design space to formulate optimized formulation for FBT liposomal system.

Electronic reproduction.
Ann Arbor, Mich. :
ProQuest,
2024

Mode of access: World Wide Web

ISBN: 9781369708226Subjects--Topical Terms:

1180569
Pharmaceutical sciences.
Subjects--Index Terms:

Central Composite DesignIndex Terms--Genre/Form:

554714
Electronic books.

Formulation and evaluation of liposomes of fenofibrate prepared by thin film hydration technique.
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504 $a Includes bibliographical references
520 $a Despite the enormous amount of effort spent during the past 44 years (greater than 114,000 scientific publications) and the well-formed consensus within the scientific community about the potential of liposomes as drug carriers, currently relatively few products (12 therapeutic products) are available on the market and all of these were approved between 1995 and 2004. Several factors may have contributed to the slow pace of commercialization of liposome drug products during the last decade: 1) the difficulties associated with identifying the formulation and process design critical quality attributes of these complex systems and 2) Higher manufacturing cost due to low preparation reproducibility and low entrapment of therapeutic active agents. Hence, there is a persistent need for the design and development of these complex systems. We have used central composite design (CCD) for the optimization of the liposomal formulation. The aim is to study the impact of process variables like Hydration volume, Hydration time, Sonication time and Drug: lecithin Ratio on quality attributes like Particle size, Peak shape, Polydispersity Index, Drug loading, Entrapment efficiency and Redispersion of the complex liposomal formulation system. A central composite design, 4 factor, face centered was employed to develop the liposomal suspension and identify the critical parameters and optimize the formulation components. Seventeen liposomal formulations were prepared with variable amounts of lecithin and drug (FBT) as per the CCD face centered design and their in-vitro dissolution studies, solid state characterization were performed. The particle sizes of all liposomal suspensions were between 99.5nm to 290 nm, however depending upon process parameters they have resulted in either monomodal, bi-modal and multimodal particle size distribution along with difference in PDI values. The entrapment efficiency greater than 70% was achieved with Drug: lecithin ratio 0.1: 3.5.The dissolution studies showed enhanced dissolution of liposomal formulation in comparison to pure FBT. The particle size distribution showed direct correlation with the dissolution profile The Drug to lecithin ratio and hydration media volume has significant impact on drug entrapment capacity of the formulation and in-vitro dissolution rate. All the formulations showed zeta potential ranging from -20.1mv to -28.3mv. DSC thermograms of FBT, showed sharp endothermic peak however, the FBT loaded liposomes showed disappearance of melting peak for FBT, indicating the molecularly dispersion of FBT in liposomes and significant physical interaction between FBT and lipid components. The FTIR spectrum showed distinctive peaks for FBT which were also observed in the liposomal formulation hence, the drug had no strong interaction with lecithin chemically. The study has created a successful design space to formulate optimized formulation for FBT liposomal system.
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