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PRINCIPLES OF COMPOUNDING

PRINCIPLES OF COMPOUNDING. Terrick Andey College of Pharmacy & Pharmaceutical Sciences Florida A&M University. February 2013. SYRUPS. Definition: concentrated solutions of sugar in water or other aqueous liquid Sugar typically used is sucrose

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PRINCIPLES OF COMPOUNDING

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  1. PRINCIPLES OF COMPOUNDING TerrickAndey College of Pharmacy & Pharmaceutical Sciences Florida A&M University February 2013

  2. SYRUPS • Definition: concentrated solutions of sugar in water or other aqueous liquid • Sugar typically used is sucrose • Syrup/Simple Syrup: concentrated (but not saturated) sucrose solution in Purified Water • Other ingredients: glycerin, sorbitol, alcohol • Medicated Syrup: when preparation contains added medicinal substances • Flavored Syrup: non-medicated syrup containing aromatic or flavored ingredients (for preparations for children)

  3. SYRUPS • Properties: • Mask bitter or unpleasant taste of drugs • Examples: Glycyrrhiza syrup, Acacia Syrup USP, Raspberry Syrup USP • Syrup with sucrose concentration of 65 %w/w is bacteriostatic • When syrup or sucrose is overheated, it caramelizes

  4. SYRUPS – Preparation • Solution with heat • Agitation without heat • Percolation

  5. SYRUPS – Solution with Heat • Solution with Heat: method of choice for: • Non-volatile medications • Thermostable ingredients • Rapid preparation • E.g.: Syrup USP • Excessive heating of syrup results in formation of caramel • Caramelization: evidenced by yellow-to-brown coloring of syrup due to burning of sucrose

  6. SYRUPS - Solution with Heat Syrup USP Rx: Sucrose 85 gm Purified Water q.s. ad to 100 ml Procedure: • Heat approx. 60 ml of distilled water to boiling • Add sucrose in small amounts to hot water while stirring • Continue adding sucrose (in small portions) allowing each batch to dissolve before adding the next • Filter syrup into a graduate cylinder; rinse the beaker with hot distilled water, pass solution through filter to obtain desired volume

  7. SYRUPS – Agitation without Heat • Agitation without Heat: • Useful were volatile agents are in formulation • Preparation is done in a bottle with a stopper twice the volume of syrup desired • Examples: Guaifenesin Syrup USP, Codeine Linctus

  8. SYRUPS – Agitation without Heat • CodeinLinctus: • Rx: Codeine Phosphate 3 gm Compound Tartrazine Solution 10 ml Benzoic Acid Solution 20 ml chloroform Spirit 20 ml Purified Water 20 ml Lemon Syrup 200 ml syrup q.s. ad to 1000 ml • Procedure: • Dissolve the codeine phosphate in the purified water • Add 500 ml of the syrup and mix • Add the other ingredients and sufficient syrup to produce 1000 ml

  9. SYRUPS – Percolation • Percolation: purified water is passed slowly through a bed of sucrose • Percolator is plugged at the neck with cotton ball or glass wool with sucrose on top • Flow of percolate is regulated by a suitable stopper • Syrup devoid of particles of sucrose is ensured by recycling percolate • Method of choice for Syrup USP & Wild Cherry Syrup

  10. SYRUPS – Percolation • Percolation: • Rx: Sucrose 85 gm Purified Water, q.s. ad to 100 ml • Procedure: • Place sucrose in a suitable percolator, the neck of which is nearly filled with packed glass wool or cotton, moistened with distilled water • Pour carefully a portion of distilled water over sucrose and regulate the outflow to a steady drip • Return the flow from the drip back over the sucrose untill all the sucrose has dissolved • Use sufficient amounts of distilled water to bring the volume to 100 ml

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  12. Preserving Syrups • Syrup, USP is protected from bacterial contamination by virtue of its high solute concentration. More dilute syrups are good media for microbial growth and require the addition of preservatives. Industrially formulated syrups often contain ingredients to improve solubility, stability, taste or appearance which also contribute to product preservation. It is necessary, from an economic standpoint, to consider the additive preservative effects of such ingredients as alcohol, glycerin, propylene glycol, and other dissolve solids. Syrup USP, having a specific gravity of 1.313 and a concentration of 85% w/v is a 65% w/w solution. This 65% by weight is the minimum amount of sucrose which will preserve neutral syrup. If one wants to formulate a syrup containing less sucrose, the quantity of alcohol, or other preservatives, may be estimated by considering the USP Syrup equivalent and the free water equivalent. One may assume that free water is preserved by 18% alcohol. • To calculate the free water equivalent, the volume occupied by the sucrose, the volume preserved by the sucrose, and the volume occupied and/or preserved by other additives must be subtracted from the total volume of the preparation. In Syrup, USP 850 g sucrose occupies an apparent volume of 550 ml; so each gram of sucrose will occupy 550/850 or 0.647 ml. If the 850 g sucrose preserves 450 ml of water, then each gram of sucrose will preserve 450/850 = 0.53 ml of water. • e.g. How much Alcohol USP is required to preserve 1L of syrup containing 500 g sucrose? • If other dissolved solids are present, their volume (often estimated) is subtracted from the free water volume. If glycerin is present, its volume preserves an equal volume of free water. If propylene glycol is present, it is considered equivalent to ethanol.

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