Injectable Biodegradable Silica Depot: Two Months of Sustained Release of the Blood Glucose Lowering Peptide, Pramlintide

Diabetes mellitus is a major healthcare challenge. Pramlintide, a peptide analogue of the hormone amylin, is currently used as an adjunct with insulin for patients who fail to achieve glycemic control with only insulin therapy. However, hypoglycemia is the dominant risk factor associated with such a...

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Published inPharmaceutics Vol. 14; no. 3; p. 553
Main Authors Tyagi, Puneet, Koskinen, Mika, Mikkola, Jari, Sarkhel, Sanjay, Leino, Lasse, Seth, Asha, Madalli, Shimona, Will, Sarah, Howard, Victor G, Brant, Helen, Corkill, Dominic
Format Journal Article
LanguageEnglish
Published Switzerland MDPI AG 02.03.2022
MDPI
Subjects
Acids
biologics
Diabetes
Drug delivery systems
Drug dosages
Glucagon
Glucose
Hormones
Insulin
long acting
Metabolism
Molybdenum
Patient compliance
Peptides
silica microparticles
sustained delivery
St Louis Missouri
United States > US
silica microparticles
biologics
sustained delivery
long acting
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Summary:Diabetes mellitus is a major healthcare challenge. Pramlintide, a peptide analogue of the hormone amylin, is currently used as an adjunct with insulin for patients who fail to achieve glycemic control with only insulin therapy. However, hypoglycemia is the dominant risk factor associated with such approaches and careful dosing of both drugs is needed. To mitigate this risk factor and compliance issues related to multiple dosing of different drugs, sustained delivery of Pramlintide from silica depot administered subcutaneously (SC) was investigated in a rat model. The pramlintide-silica microparticle hydrogel depot was formulated by spray drying of silica sol-gels. In vitro dissolution tests revealed an initial burst of pramlintide followed by controlled release due to the dissolution of the silica matrix. At higher dosing, pramlintide released from subcutaneously administered silica depot in rats showed a steady concentration of 500 pM in serum for 60 days. Released pramlintide retained its pharmacological activity in vivo, as evidenced by loss of weight. The biodegradable silica matrix offers a sustained release of pramlintide for at least two months in the rat model and shows potential for clinical applications.
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ISSN:1999-4923
1999-4923
DOI:10.3390/pharmaceutics14030553