Development of a Lyophilized Formulation of Pegaspargase and Comparability Versus Liquid Pegaspargase

Monoclonal antibodies (Mabs) have been useful for immunoscintigraphic applications in clinical diagnosis since they were introduced in the practice of nuclear medicine. The ior egf/r3 (Centis, Cuba) is a murine monoclonal antibody against epidermal growth factor receptor (EGF-R) and has been widely used in the radioimmunodiagnosis of tumors of epithelial origin. Labeled with 99mTc, its main application in Nuclear Medicine is the follow up, detection and evaluation of tumor recurrences. The objective of this work is to describe the preparation of a lyophilized formulation (kit) for radiolabeling the Mab ior egf/r3 with 99mTc for immunoscintigraphic applications. Radiolabeling efficiency, effects on immunoreactivity, image studies and stability of the formulation are reported. The study demonstrated that the kit formulation can be labeled with 99mTc at high yields and can be used to visualize in vivo human tumors of epithelial origin by immunoscintigraphy studies.

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Improvement of Stability and Dissolution of Prostaglandin E1 by Maltosyl-.BETA.-cyclodextrin in Lyophilized Formulation.

Chemical and Pharmaceutical Bulletin ◽

10.1248/cpb.40.747 ◽

1992 ◽

Vol 40 (3) ◽

pp. 747-751 ◽

Cited By ~ 24

Author(s):

Masanobu YAMAMOTO ◽

Fumitoshi HIRAYAMA ◽

Kaneto UEKAMA

Keyword(s):

Prostaglandin E1 ◽

Beta Cyclodextrin ◽

Lyophilized Formulation

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Stability characterization and appearance of particulates in a lyophilized formulation of a model peptide hormone-human secretin

International Journal of Pharmaceutics ◽

10.1016/j.ijpharm.2015.01.044 ◽

2015 ◽

Vol 481 (1-2) ◽

pp. 104-113 ◽

Cited By ~ 4

Author(s):

Charudharshini Srinivasan ◽

Akhtar Siddiqui ◽

Maxwell Korang-Yeboah ◽

Mansoor A. Khan

Keyword(s):

Peptide Hormone ◽

Model Peptide ◽

Lyophilized Formulation

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Randomized, Double-Blind Study of the Safety of the Liquid Versus Lyophilized Formulation of Palivizumab in Premature Infants and Children with Chronic Lung Disease of Prematurity

Infectious Diseases and Therapy ◽

10.1007/s40121-014-0033-y ◽

2014 ◽

Vol 3 (2) ◽

pp. 339-347 ◽

Cited By ~ 3

Author(s):

Doris Makari ◽

Kathryn M. Jensen ◽

Brian Harris ◽

Hasan S. Jafri

Keyword(s):

Lung Disease ◽

Premature Infants ◽

Chronic Lung Disease ◽

Infants And Children ◽

Blind Study ◽

Double Blind Study ◽

Double Blind ◽

Lyophilized Formulation

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Pharmaceutical development of a parenteral lyophilized formulation of the antimetastatic ruthenium complex NAMI-A

International Journal of Pharmaceutics ◽

10.1016/s0378-5173(02)00459-3 ◽

2002 ◽

Vol 248 (1-2) ◽

pp. 247-259 ◽

Cited By ~ 10

Author(s):

M Bouma ◽

B Nuijen ◽

G Sava ◽

A Perbellini ◽

A Flaibani ◽

...

Keyword(s):

Ruthenium Complex ◽

Pharmaceutical Development ◽

Lyophilized Formulation

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Lyophilized Symbiotic Mitigates Mucositis Induced by 5-Fluorouracil

Frontiers in Pharmacology ◽

10.3389/fphar.2021.755871 ◽

2021 ◽

Vol 12 ◽

Author(s):

Bruna Savassi ◽

Bárbara F. Cordeiro ◽

Sara H. Silva ◽

Emiliano R. Oliveira ◽

Giovanna Belo ◽

...

Keyword(s):

Weight Loss ◽

Adjuvant Treatment ◽

Protein Isolate ◽

Mucosal Inflammation ◽

Lyophilized Formulation ◽

Reduce Weight Loss ◽

Tnf Α ◽

Probiotic Strains ◽

Pro Inflammatory Cytokines

Mucositis is an adverse effect of cancer chemotherapies using 5-Fluorouracil (5-FU). It is characterized by mucosal inflammation, pain, diarrhea, and weight loss. Some studies reported promising healing effects of probiotic strains, when associated with prebiotics, as adjuvant treatment of mucositis. We developed a lyophilized symbiotic product, containing skimmed milk, supplemented with whey protein isolate (WPI) and with fructooligosaccharides (FOS), and fermented by Lactobacillus casei BL23, Lactiplantibacillus plantarum B7, and Lacticaseibacillus rhamnosus B1. In a mice 5-FU mucositis model, this symbiotic lyophilized formulation was able to reduce weight loss and intestinal permeability. This last was determined in vivo by quantifying blood radioactivity after oral administration of 99mTc-DTPA. Finally, histological damages caused by 5-FU-induced mucositis were monitored. Consumption of the symbiotic formulation caused a reduced score of inflammation in the duodenum, ileum, and colon. In addition, it decreased levels of pro-inflammatory cytokines IL-1β, IL-6, IL-17, and TNF-α in the mice ileum. The symbiotic product developed in this work thus represents a promising adjuvant treatment of mucositis.

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