Pharmaceutical composition for anaemia
Inventors
SINGH, Ankit Shyam • MISHRA, Vedprakash • TONGRA, Neelima
Assignees
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Publication Number
US-12016906-B2
Publication Date
2024-06-25
Expiration Date
Abstract
The present invention relates to a pharmaceutical composition/formulation for use in treatment of Iron Deficiency Anaemia (IDA), Anaemia of Inflammation (AOI) and neuro-degenerative disorders. More particularly, the invention relates to a pharmaceutical composition/formulation comprising a synergistic combination of Lactoferrin and Guanosine Nucleotides or a pharmaceutically acceptable salt thereof. The application also provides various formulations and methods of preparing the same.
Core Innovation
The invention relates to a pharmaceutical composition for treating iron deficiency anaemia (IDA) and anaemia of inflammation (AOI), and potentially neuro-degenerative disorders, using a synergistic combination of lactoferrin (LF) with natural guanosine nucleotides (GMP/GDP/GTP) or pharmaceutically acceptable salts thereof. The composition comprises lactoferrin and one or more guanosine nucleotides, with lactoferrin present in a defined weight fraction of the composition.
The rationale is described in terms of iron homeostasis and regulation of the hepcidin–ferroportin axis and IL-6. The described mechanisms include hepcidin binding and/or effects on iron transport, including increased DMT1/TFR1 and ferroportin stabilization, which are presented as supporting the observed improvements in iron-related biomarkers.
Documented examples include pharmaceutical compositions and formulation options such as enteric-coated tablets and various excipients and coating systems. The document also describes comparison studies in iron-deficient diet-induced anaemia, where the combination of lactoferrin with guanosine nucleotides is reported to improve hemoglobin, hematocrit, and serum iron, while affecting ferroportin and reducing ferritin, hepcidin, and IL-6 in combination groups relative to single-agent groups and FeSO4 in several endpoints.
Claims Coverage
The document presents one independent claim covering a lactoferrin plus guanosine nucleotide pharmaceutical composition with a defined lactoferrin weight fraction, and multiple dependent claim refinements that further define nucleotide species, salt forms, nucleotide weight fraction, and formulation/ingredient constraints. The main inventive features are therefore centered on the LF + guanosine nucleotide combination and quantitative compositional constraints, with additional specification of which nucleotide/salt forms are encompassed.
Lactoferrin and guanosine nucleotide combination in a defined lactoferrin range
A pharmaceutical composition comprising a combination of lactoferrin and one or more guanosine nucleotide or a pharmaceutically acceptable salt thereof, wherein an amount of the lactoferrin ranges from 5 to 90% by wt. of the composition.
Selected guanosine nucleotide species
The guanosine nucleotide is selected from GMP, GDP, GTP, or a combination of them.
Selected pharmaceutically acceptable salt forms for guanosine nucleotide
A pharmaceutically acceptable salt of a guanosine nucleotide is selected from the listed salts including hydrochloride, sulfate, phosphate, acetate, lactate, citrate, and other specified salt forms, alone or in combination.
Defined guanosine nucleotide weight fraction
The guanosine nucleotide is present at 1 to 75 wt% of the composition.
Across the independent claim and its dependents, the coverage focuses on combining lactoferrin with one or more guanosine nucleotides (or pharmaceutically acceptable salts) and constraining lactoferrin to 5 to 90% by wt, with further constraints on which guanosine nucleotide species and salt forms are included and on the guanosine nucleotide weight fraction.
Stated Advantages
Improved hemoglobin (Hb)
Improved hematocrit
Improved serum iron
Increased ferroportin
Reduced ferritin
Reduced hepcidin
Reduced IL-6
Combination groups outperform single agents and comparator FeSO4 in several endpoints
Documented Applications
Treatment of iron deficiency anaemia (IDA)
Treatment of anaemia of inflammation (AOI)
Potential treatment of neuro-degenerative disorders
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