ABSTRACT:
The BCS class II drug Atorvastatin calcium is an antihyperlipidemic agent with low aqueous solubility and high permeability. Poor water solubility and a slow dissolution rate are problems for the majority of new and existing biologically active compounds, solubility was improved in this work in a novel way. Through the use of Colloidal Nano particulate dispersion technology, the current study aimed to improve the oral bioavailability of the drug Atorvastatin calcium, a poorly water soluble drug, by speeding up its rate of dissolution. In the present work Colloidal Nano particulate dispersion is made by nanoprecipitation technique in the presence of Sodium lauryl sulfate as a surfactant, Poloxamer 188 as a wetting agent and HPMC E-15 as a stabilizer. Particle size, DSC, FTIR and XRD were used to analyse and characterize the prepared Colloidal Nano particulate dispersion. FTIR spectrum revealed that there are no interactions between drug and carriers. Drug content, entrapment effectiveness and in-vitro dissolution were all assessed for the formulations. Finally it was concluded that formulating poorly soluble drugs in the form of Colloidal Nano particulate dispersion would be a promising approach in delivery of poor water soluble drugs by oral route in a simple and effective way. It optimized Colloidal Nano particulate dispersion formulation containing Atorvastatin calcium showed higher in vitro drug release, as compared to marketed formulation. The stability study of Colloidal Nano particulate dispersion has shown suitable results. It revolves that there’s no change in drug content, redispersibility study and particle size.
Cite this article:
Pranali P. Patil, Harshal D. Mahajan, Vinod S. Ahire, Tanvirahmad J. Shaikh. Evaluation and in vitro assessment physical characterization of the oral Colloidal Nano particulate dispersion of Atorvastatin calcium and therapeutic efficacy by improving its solubility. IJRPAS, November 2025; 4(11): 91-100.DOI: https://doi.org/https://doi.org/10.71431/IJRPAS.2025.41109
1.
Seedher N, Bhatia S. Solubility
enhancement of Cox-2 inhibitors using various solvent systems.AAPS
PharmSciTech.2003; 4(3):1–8
2.
LipinskiC.PoorAqueousSolubility-
AnIndustry Wide Problem in Drug Discovery. Am.Pharm.Rev.2002;5: 82
3.
Kipp J, Wong JCT, Dotty MJ and Rebbech
Cl.Microprecipitation MethodofPreparing Submicron Suspension. U.S.PATENT;2003.
4.
HassanMA,SuleimanMS,Najib NM.Improvement
of the In-Vitro Dissolution Charracteristics of Famotidine by Inclusive in
B-Cyclodextrine. IntJPharm. 1990;58:19– 24.
5.
RaniaHF,MohammedAK.Enhancement of
famotidine dissolution rate through liquisolid tablets. Formulation. In vitro
and in vivo evaluation. EurJ PharmBiopharm. 2008;69:993–1003
6.
Mahajan D. Harshal *, Wagh D. Rajendra ,
Baviskar T. Dheeraj , Mahajan S. Hitendra and Mali J. Bhushan.Development and
evaluation of moxifloxacin hydrochloride loaded poly lactic-co-glycolic acid
nanoparticles for ocular drug delivery.International Journal of Pharmaceutical Sciences and
Research.2020;11(11): 5685-5693.
7.
Mahajan Harshal. D., Wagh Rajendra. D.,
Baviskar Dheeraj. T., Moxifloxacin Hydrochloride loaded polymeric nanoparticles
for ocular drug delivery: In-Vitro and Ex- Vivo Studies, Indian journal of
novel drug delivery 11(4), oct-dec;2019;211-219.
8.
Gupta P., Pandit J., Ajay
P., Swaroop P. and Gupta S., Pharmaceutical Nanotechnology Novel
Nanoemulsion-High Energy Emulsification Preparation, Evaluation and Aplication.
The Pharma Research, 2010; 3; 117-138.
9.
S.A. Abdel Halim*, S. Salah: Development
of nanoparticulate formulations for ocular delivery of prednisolone acetate:
preparation and characterization,J. DRUG DEL. SCI. TECH., 2014;24 (2) ;159-165.
10.
V.Viswanath, B. Narasimha Rao, K. Gnana
Prakash, S. Rahath Fatima, G. Krishnaveni, Formulation and evaluation of
Terbulatine sulphate loaded inhalation nanoparticles for pulmonary drug
delivery system. Int. Journal Pharmacy Sci. Rev.Res.2017, 42 (1), 256- 260
11.
Pignatello R, Bueolo C, Spedalieri G,
Maltese A, PuglisFlurbiprofen-loaded aerylate polymer Colloidal Nano
particulate dispersionBiomaterials. 2002; 23: 3247-3255.
12.
Pore YV, Shinde VR, Rao JV. Physical
stabilization of amorphous itraconazole in solid dispersions for improved
dissolution profile. Journal of Applied Pharmaceutical Science. 2016
Oct;6(10):037-44.
13.
Junise V, R. Sarawasati, Development and
characterization of chitosan nanoparticles loaded with isoniazid, Journal
Pharma Sci.2015, 4(3)190-195.
14.
Roya Yadollahi, Krasimir Vasilev, Clive A. Prestidge and Spomenka Simovic, Polymeric Colloidal Nano
particulate dispersions for Enhanced Dissolution of Water Insoluble Drugsournal of Nanomaterials. 2013, Article ID 170201,
1-10.
15.
Yan G. Preparation, characterization,
pharmacokinetics, and tissue distribution of curcumin Colloidal Nano
particulate dispersion with TPGS as a stabilizer. Drug Dev Ind Pharm 2010;36:1225–34
16.
Rupali LS, Nilesh K. Formulation and
evaluation of a Colloidal Nano particulate dispersion delivery system for
simvastatin. Int J Pharm Sci Nanotech 2014;7:2459-76.
17.
Higuchi T.-Rate of release of medicaments
from ointment bases containing drugs in suspension, J. Pharma
Sci.,1961,50(10),874-875.
18.
Drug Stability: Principle and Practices,
third edition, revised and expanded edited by
Jens T. Carstensen and C.T. Rhodes, Drug and Pharmaceutical Science,
Vol.107, Marcel Dekker New Work.