Acetaminofen Estabilidad

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Scholars Research Library
Der Pharmacia Lettre, 2012, 4 (1):170-174
(http://scholarsresearchlibrary.com/archive.html)
ISSN 0975-5071
USA CODEN: DPLEB4

Formulation and Evaluation of Paracetamol Syrup Made by Mixed
Solvency Concept
R. K. Maheshwari and R. Rajagopalan*
Department of Pharmacy, Shri Govindram Seksaria Institute ofTechnology and Science,
Indore, Madhya Pradesh, India
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ABSTRACT
Based on the large number experiments on solubilization of poorly water- soluble drugs, the
author is of the opinion that hydrotropy is another type of cosolvency and all water soluble
substances whether solids, liquids or gases have solubilizing properties.Therefore, aqueous
solutions containing small quantities of several water-soluble excipients giving a concentrated
solution, may act as a solvent system for some poorly water-soluble drugs. This is one of the
concepts of mixed-solvency. This same concept has been explored to formulate the syrups
(solutions) of poorly water-soluble drug Paracetamol (as a model drug). For this, the blendscontaining solubilizers from the category of hydrotropes, co solvents and water soluble solids
were employed. The blends of randomly selected solubilizers were used for solubility studies.
Based on the solubility studies, few blends showing largest solubilities were employed to make
the syrup. This may reduce the individual concentration of solubilizers and so reduce their
potential of toxicities.The formulated syrups were subjected to accelerated stability studies and
they were found quite stable.
Keywords: Mixed solvency, syrup, Paracetamol.
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INTRODUCTION

The formulation development of oral liquid solutions presents many technical problems to the
industrial pharmacist. Special techniques are requiredto solubilize poorly water- soluble drugs.
Solubilization of poorly water-soluble drugs has been a very important issue in screening studies
of new chemical entities as well as in formulation research. Solubility prediction in
pharmaceutical area is still a challenging subject and requires further investigations from both
experimental and computational points of view.

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R. Rajagopalan et al
Der Pharmacia Lettre, 2012, 4 (1):170-174
_____________________________________________________________________________
Maheshwari has applied hydrotropic solubilization technique to quantitatively estimate a large
number of poorly water-soluble drugs. [1-26] He is of the opinion that hydrotropic solubilization
is just like co-solvency.
Maheshwari27-29 hasproposed the concept of mixed solvency. The aurhor is of the opinion that
all substances have solubilizing power and all soluble substances whether liquids, solids, or
gases may enhance the aqueous solubility of poorly water-soluble drugs. He has carried out
solubility studies on poorly water-soluble drug, salicylic acid (as model drug). Solubility studies
were carried in the solutions containinghydrotropic agents (urea and sodium citrate), co solvents
(glycerin, propylene glycol, PEG 300 and PEG 400) and water soluble solids (PEG 4000 and
PEG 6000) individually as well as in 10 randomly prepared blends employing solubilizers from
these categories keeping total concentration constant i.e. 40% w/v. Results showed that seven out
of ten blends produced synergistic effect on solubilityenhancement.
The application of the same principle has been employed in the present research work to develop
the syrup formulations (solutions) of the model poorly water-soluble drug, paracetmaol
employing the solubilizers from the category of hydrotropes ( sodium citrate, sodium acetate and
urea), co-solvents (PEG 200, PEG 300, PEG 400, PEG 600, propylene glycol and ethanol) and
water...