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IRON SUPPLEMENTATION • • • • • Iron is an essential constituent of the body; necessary for hemoglobin formation and oxidative processes of living tissues. Iron deficiency is the most common nutritional disorder in the world. Approximately 25% of the world’s population is iron deficient. Studies have indicated that iron supplementation may increase cognitive skills in children and adolescents with iron deficiency. The major activity of supplemental iron is in the prevention and treatment of iron deficiency anemia. A number of ferrous and ferric salts are available for the same. However, the compliance with iron salts is poor, mainly because of the associated metallic taste. Iron in ferrous state is more readily absorbed by the body than in ferric state. COMPLIANCE OF MEDICINES IN PEDIATRICS Taste is a major consideration when designing a pediatric compliant dosage form. ‘Melt in Mouth’ solid dosage forms encompass the advantages of solid and liquid dosage forms. ‘Melt in Mouth’ pellets or ‘Meltlets’ are : A novel and an innovative extension of ‘Melt in mouth’ solid dosage forms Fast dissolving; when placed in mouth Pleasant tasting, flavored Unit dosage form, packed in sachets and can be directly emptied in the child’s mouth Can be used for administering high dose drugs ‘MELT IN MOUTH’ DOSAGE FORMS ARE A NOVEL AND AN INNOVATIVE DOSAGE FORM AND ARE EXPECTED TO IMPROVE THE ACCEPTANCE OF MEDICINES BY PEDIATRIC POPULATION OBJECTIVES OF THE INVESTIGATION Formulation of palatable ‘Melt in Mouth’ pellets of Ferrous fumarate that would improve the compliance of the same in pediatrics. Development of analytical technique for Ferrous fumarate Exploiting ‘Extrusion – Spheronization’, as a technique for formulating the Melt in mouth pellets. This technique has been explored only for the formulation of immediate and controlled release pellets. MATERIALS USED IN THE STUDY Ferrous fumarate Sweetener Novel channelizing agent Instacoat Flavor * Lemon Lime Flavor Novel Disintegrant Diluents Spheronization aid Flow enhancer * Instacoat Flavor is a blend of color, flavor and a cellulosic polymer. This is added as an excipient to mask the metallic taste of iron salt and to increase the palatibility and aesthetic appeal of the formulation. EQUIPMENTS USED IN THE STUDY : • • • Extruder E – 65 (R. R. Enterprises) Spheronizer S – 120 (R. R. Enterprises) Drying Oven (Expo, EIC – IA) IN – VITRO DISSOLUTION STUDIES: USP Type II, 75 rpm, 900 ml Dissolution Medium Dissolution Medium : USP pH 1.2 Hydrochloride Acid Buffer containing 0.5% w/v Sodium Lauryl Sulfate OPTIMIZATION OF EXTRUSION - SPHERONIZATION Extrusion was optimized for : Extruder speed Extruder screen size Spheronization was optimised for : Spheronization speed Spheronization dwell time Formulation optimization : Ratio of Diluents Quantity of granulating medium Drying Time Quantity of Instacoat Flavor, Lemon flavor and disintegrant FORMULATION OF THE ‘MELT IN MOUTH’ PELLETS Drug Sweetener Disintegrant Channelizing Agent Flavour (I) Instacoat Flavour (II) Cellulose Derivative POWDER BLEND Diluent Granulation Extrude (Extrude E – 65) Spheronize (Spheronizer S – 160) Dry in oven for 4 hours at 60C and fractionate (16/20 #), Add Talc Fill in sachets The formulated pellets were evaluated by a panel of 10 human volunteers and the results are as indicated : MELT IN MOUTH PELLETS (I) Volunteers I II III IV V VI VII VIII IX X +++ ++ +++ +++ ++ +++ +++ +++ +++ +++ Mouthfeel ++ + +++ ++ ++ ++ +++ ++ ++ ++ Sweetness +++ +++ ++ +++ +++ +++ +++ ++ ++ ++ Flavor +++ ++ ++ +++ ++ +++ +++ ++ +++ ++ Disintegration +++ ++ ++ +++ ++ +++ +++ +++ ++ ++ - - Slight - - - - - - Slight Parameter Taste Aftertaste ++ None Good + +++ Ok Excellent The formulated pellets were evaluated by a panel of 10 human volunteers and the results are as indicated : MELT IN MOUTH PELLETS (II) Volunteers I II III IV V VI VII VIII IX X +++ +++ +++ +++ +++ +++ +++ +++ +++ +++ Mouthfeel ++ + + ++ +++ +++ ++ +++ +++ ++ Sweetness +++ +++ +++ +++ +++ +++ +++ ++ ++ +++ Flavor +++ ++ ++ +++ +++ ++ ++ ++ +++ ++ Disintegration +++ ++ ++ +++ ++ +++ +++ +++ ++ ++ - - - - - - - - - Parameter Taste Aftertaste ++ None Good + +++ Ok Excellent - ANALYTICAL METHOD DEVELOPMENT TITRIMETRY : (As per Indian Pharmacopoeia 1996) For drug content as well as stability indicating assay. Analysis of Ferrous Iron : Analysis of Ferric iron: Titrant : Ceric Ammonium Sulfate VS Indicator : Ferroin End Point : Red to pale blue Standardized against : Sodium Thiosulphate Titrant : Sodium Thiosulphate VS Indicator : Starch solution End Point : Blue to colourless Standardized against : Potassium bromate COLORIMETRY: For drug content and analysis of drug in an in vitro release study. Principle : Iron forms a red colored complex with Thioglycollic acid in the presence of citric acid and at an alkaline pH.
