Abstract
The development of a generic liposomal doxorubicin product requires the study of critical physicochemical properties of the formulation. Food and Drug Administration (FDA) draft guideline has suggested few parameters to be tested for in vitro bioequivalence study which include liposomal composition, state of encapsulated drug, internal environment, liposomal morphology and number of lamellae, lipid bilayer phase transition, liposomal size distribution, grafted Polyethylene Glycol (PEG) at liposomal surface, electric surface potential or charge and in vitro leakage under multiple conditions. Characteristic features of components of liposomal doxorubicin formulation and detail of parameters to be studied have been discussed. This review compile specific, current and historical research outcomes on in vitro analysis of liposomal doxorubicin and highlights the important features that have a critical impact on properties of liposomal doxorubicin formulation. It will provide a better insight to the generic manufacturers and will help them to identify the critical quality attributes during the formulation development phase.
Highlights
Doxorubicin is a member of the anthracycline class of antineoplastic drugs and is effective in a variety of solid tumours and hematological malignancies [1]
Maryam et al (2019) have made attempts to reduce the toxicity of doxorubicin by co-administering it with PEGylated liposomal galbanic acid (PLGba) as it could improve the outcome of the chemotherapy even with a reduced dose of PEGylated liposomal doxorubicin (PLD) [6]
DOXIL/Caelyx has a longer circulation lifetime which is due to the steric barrier provided by the surface-grafted Polyethylene Glycol (PEG), which leads to large changes in bio-distribution and increased amounts of drug being delivered to the skin
Summary
Doxorubicin is a member of the anthracycline class of antineoplastic drugs and is effective in a variety of solid tumours and hematological malignancies [1]. Doxorubicin (Dox) hydrochloride (C27H29NO4) is a high molecular weight compound (579.98 gm/mol) and is isolated from Streptomyces peucetius It was first introduced in the 1970s, and since it has become one of the most commonly used drugs for the treatment of both hematological and solid tumors [2]. DOXIL/Caelyx has a longer circulation lifetime which is due to the steric barrier provided by the surface-grafted PEG, which leads to large changes in bio-distribution and increased amounts of drug being delivered to the skin. This has advantages for the treatment of skin localized cancers such as Kaposi’s sarcoma but disadvantages in the observation of new dose-limiting toxicities such as hand and foot syndrome [9].
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