Page 26 - 2021

Ph.D.
(Pharmacy)
FORMULATION, OPTIMIZATION AND CHARACTERIZATION OF
NANOFORMULATIONS OF AN ANTIBIOTIC

Ph.D. Scholar : Goswami Nilamgiri Dahyagiri
Research Supervisor : Dr. Rakesh P. Patel

Regi. No.: 16146021004
Abstract :
The research work shall emphasize the design, development, and characterization of the
nanoformulations of Nitrofurantoin (NFT) by formulating solid lipid nanoparticles,
nanostructured lipid carrier, nanosuspension, and nanocrystals for oral drug delivery of
Nitrofurantoin, a broad-spectrum bactericidal antibiotic.

The analytical method of NFT was developed by HPLC-UV technique. Various
characterization studies like FTIR, DSC, XRD were performed to check the compatibility
study with drug and excipients. SLN is prepared by hot homogenization Process using
glyceryl monostearate and Glyceryl behenate along with poloxamer 188 and purified
water. A nanostructured lipid carrier was prepared by using glyceryl monostearate and
miglyol 812 along with poloxamer 188 and purified water. Nanosuspension of NFT was
prepared by a high speed homogenization process using HPMC E3, poloxamer 188, and
purified water. Nanocrystals were formulated by using dichloromethane and HPMC E3
along with poloxamer 188 and purified water. The preliminary formulation of solid lipid
nanoparticles, nanostructured lipid carriers, nanosuspension, and nanocrystals was
tested for zeta potential, polydispersity index, and particle size. The formulations were
optimized following 32 factorial designs. Particle size, polydispersity index, zeta potential,
and entrapment efficiency were evaluated for the confirmation of nanoformulations. The
surface morphology of final formulations was confirmed with SEM and TEM studies. In-
vitro releases were studies of the above nanoformulations. Stability studies of final
nanoformulations were checked for 6 months as per the ICH guidelines. Finally, In-vivo
studies of these solid lipid nanoparticles, nanostructured lipid carrier, nanosuspension,
and nanocrystals were carried out for bioavailability study and compared with marketed
formulations. From the development, optimization, and characterization of NFT loaded
nanoformulations, it is concluded that solid lipid nanoparticles, nanostructured lipid
carrier, nanosuspension, and nanocrystals were showed satisfactory outcomes for drug
release profile and bioavailability. Among all the developed nanoformulations solid lipid
nanoparticles of NFT found a better release profile with increment in bioavailability.

Key words: Nitrofurantoin, Glyceryl Monostearate, Glyceryl Behenate, NFT, Miglyol 812,
Solid Lipid Nanoparticles, Nanostructured Lipid Carriers, Nanocrystals, Nanosuspension

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