Study on usage and evaluation of stevioside as sweetening agent in salbutamol sulphate and Bromhexine hydrochloride syrups

摘要

Stevioside is an intense sweetener ideally suited for liquid oral dosage forms such as Syrups, Dry syrups and suspensions. In the study syrups were prepared using stevioside as sweetener in 0.5 and 1% w/v concentration, salbutamol sulphate and Bromhexine hydrochloride in combination as model drugs. The usage of stevioside can offer many advantages to patients suffering from Diabetes, Phenylketonurea and calorie conscious, ranging from pediatrics to geriatrics. If the sweetener is soluble in the solvent, concentration of stevioside required is less i.e. up to 0.5% w/v. Formulated liquid oral dosage forms were stable at room temperature and showed good sweetness and palatability and were evaluated for drug content, viscosity, pH, and compatibility studies. Evaluation of the sweeteners and palatability was done using a panel of trained volunteers and it was observed that concentration of 0.5% w/v of Stevioside showed good sweetness and palatability. Introduction Salbutamol sulphate and Bromhexine hydrochloride is an orally administered Bronchodilator and Mucolytic agent respectively. Preferably given in sinusitis, productive cough and other allergic conditions in combination therapy to overcome the symptoms related. Salbutamol sulphate and Bromhexine hydrochloride can be administered to all range of patients ranging from pediatrics to geriatrics in liquid oral dosages 1,2 .The syrups which are available in the market either they are made up synthetic or semisynhtetic origin and have reported to cause many causalities in patients, and the syrups of sucrose may contraindicated in patients suffering from diabetes, phenylketonurea and calorie conscious. So usage of these types of sweetening agents in formulations have made their use restricted to a narrow range of patients on the basis of their above mentioned pathological conditions 3 . Though many types of syrup of Salbutamol sulphate and Bromhexine hydrochloride are available commercially, no work was reported on the pharmaceutical formulations aspects using stevioside as sweetener. Among the various methods of preparations of syrups, making Solutions of ingredients with the aid of heat is an industrially accepted method and it is well practiced in laboratory scale also. Among the various sweeteners available, stevioside can also be used as an alternative for sucrose and synthetics. Stevioside has to receive increased acceptability and application in pharmaceutical formulations in coming years due to approval by various regulatory agencies. Stevioside is a Diterpine glycoside extracted from the plant Stevia reboudiana 4 , it is white or creamy-white coloured free flowing powder with intense sweet taste. Soluble in cold water, ethanol, methanol and ether. It is generally regarded as a non-toxic and non-irritant material .It has been accepted by WHO and it is added in Generally Recognized as Safe (GRAS) class. It has not shown any interaction with the drug and analyzed for the results of drug content, viscosity, stability and palatability and are in acceptable range. In the present work syrups of Salbutamol sulphate and Bromhexine hydrochloride were formulated and evaluated with an objective of enhancing the sweetness and palatability. Materials Salbutamol sulphate and Bromhexine hydrochloride were gift sample from M/s Crystal Pharmaceutical Ltd, Hubli and Elvina Pharmaceutical Ltd. Kotur. Propylene glycol, Menthol was gift samples from S.D. Fine Chem. Ltd, were gift samples from S.D. Fine Chem. Ltd; Sodium hydroxide was gift sample from Ranbaxy fine chem. Ltd; Colour Erythrosine was gift sample from M/s Elvina Pharmaceutical Ltd; Banana flavour and Saffron essence were gift samples from DFF Ltd, Bangalore. Chloroform water was in-house preparation, Stevioside was gift sample from M/s Qufu haigan stevia pvt.ltd Quingado, China. Method Salbutamol sulphate and Bromhexine hydrochloride Preparation of syrup 5 :( f1 and f2)Add about 40mL of D.M water to the beaker and heat it to about 70