title: Comparative plasma and tissue distribution of Sun Pharma's generic doxorubicin HCl liposome injection versus Caelyx®(doxorubicin HCl liposome injection) in syngeneic fibrosarcoma-bearing BALB/c mice and Sprague-Dawley rats.
abstract: OBJECTIVE
  The liposomal formulation of doxorubicin [doxorubicin (DXR) hydrochloride (HCl) liposome injection, Caelyx®] alters the tissue distribution of DXR as compared with nonliposomal DXR, resulting in an improved benefit-risk profile. We conducted studies in murine models to compare the plasma and tissue distribution of a proposed generic DXR HCl liposome injection developed by Sun Pharmaceuticals Industries Limited (SPIL DXR HCl liposome injection) with Caelyx®.
  
  
  METHODS
  The plasma and tissue distributions of the SPIL and reference DXR HCl liposome injections were compared in syngeneic fibrosarcoma-bearing BALB/c mice and Sprague-Dawley rats. Different batches and different lots of the same batch of the reference product were also compared with each other.
  
  
  RESULTS
  The SPIL and reference DXR HCl liposome injections exhibited generally comparable plasma and tissue distribution profiles in both models. While minor differences were observed between the two products in some tissues, different batches and lots of the reference product also showed some differences in the distribution of various analytes in some tissues. The ratios of estimated free to encapsulated DXR for plasma and tissue were generally comparable between the SPIL and reference DXR HCl liposome injections in both models, indicating similar extents of absorption into the tissues and similar rates of drug release from liposomes.
  
  
  CONCLUSIONS
  The plasma and tissue distribution profiles of the SPIL and reference DXR HCl liposome injections were shown to be generally comparable. Inconsistencies between the products observed in some tissues were thought to be due to biological variation.
authors.affiliation: Sun Pharma Advanced Research Company Ltd., 17 B Mahal Industrial Estate, Mahakali Caves Road, Andheri (East), Mumbai, Maharashtra, 400 093, India. vinod.burade@sunpharma.com.
authors.forename: Vinod
authors.initials: V
authors.lastname: Burade
authors.affiliation: Sun Pharmaceutical Industries Ltd., Sun Pharma Advanced Research Centre (SPARC), Tandalja, Vadodara, Gujarat, 390 020, India.
authors.forename: Subhas
authors.initials: S
authors.lastname: Bhowmick
authors.affiliation: Sun Pharma Advanced Research Company Ltd., 17 B Mahal Industrial Estate, Mahakali Caves Road, Andheri (East), Mumbai, Maharashtra, 400 093, India.
authors.forename: Kuntal
authors.initials: K
authors.lastname: Maiti
authors.affiliation: Sun Pharma Advanced Research Company Ltd., 17 B Mahal Industrial Estate, Mahakali Caves Road, Andheri (East), Mumbai, Maharashtra, 400 093, India.
authors.forename: Rishit
authors.initials: R
authors.lastname: Zalawadia
authors.affiliation: Sun Pharmaceutical Industries Ltd., Sun Pharma Advanced Research Centre (SPARC), Tandalja, Vadodara, Gujarat, 390 020, India.
authors.forename: Deepak
authors.initials: D
authors.lastname: Jain
authors.affiliation: Sun Pharmaceutical Industries Ltd., Sun Pharma Advanced Research Centre (SPARC), Tandalja, Vadodara, Gujarat, 390 020, India.
authors.forename: Thennati
authors.initials: T
authors.lastname: Rajamannar
mesh_terms: D000818:Animals; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D045744:Cell Line, Tumor; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D004339:Drug Compounding; D016568:Drugs, Generic; D005354:Fibrosarcoma / Q000188:drug therapy*; D007267:Injections; D008081:Liposomes; D008297:Male; D051379:Mice; D008807:Mice, Inbred BALB C; D009368:Neoplasm Transplantation; D009374:Neoplasms, Experimental / Q000188:drug therapy; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use; D051381:Rats; D017207:Rats, Sprague-Dawley; D014018:Tissue Distribution
chemical_list: D000903:Antibiotics, Antineoplastic; D016568:Drugs, Generic; D008081:Liposomes; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin
keywords: Anthracycline; Doxorubicin HCl liposome injection; Pharmacokinetics; Plasma distribution; Preclinical; Tissue distribution