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126 Cards in this Set
- Front
- Back
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How would you basically define an antioxidant?
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As an excipient added to a pharmaceutical product intended to retard or prevent the oxidation of the active ingredient.
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What are the four main types of antioxidants?
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Oxygen Scavengers, Chain Terminators, Reducing agents, and chelating agents
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How do oxygen scavengers serve as antioxidants?
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They are more easily oxidized when compared to the active ingredient,
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Provide some examples of oxygen scavengers.
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Ascorbic Acid, sulfites, monothioglycerol
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How do chain terminators serve as antioxidants?
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They provide a hydrogen ion or an electron.
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Provide some examples of chain terminators.
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BHA, BHT, Tocopherols (VitE)
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How do reducing agents serve as antioxidants?
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They will reverse the oxidation of the AI compound.
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What are some environmental factors that we want to control so that our antioxidants aren't working in vain?
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Control the temperature, exposure of the drug to light, and control the pH.
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Why would we want to control the temperature, light exposure, or pH of a product?
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Since high temperatures, light exposure, and low pH will encourage oxidation, we would like do prevent these from encouraging oxidation by limiting the drugs exposure to these elements.
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What are some ideal properties of antioxidants?
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Effective at low, non-pharmacologically active concentrations, Stable and effective over wide pH and temperature ranges, be compatible with a variety of drugs and containers, be free from objectionable taste, odor, and irritation, and finally, to be colorless in the original and oxidized states.
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What are some examples of Aqeous system antioxidants?
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Ascorbic Acid, Sodium Bisulfite, and Sodium Thiosulfate
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What are some examples of Oil system antioxidants?
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Ascorbyl Palmitate, Butylated Hydroxyanisole (BHA), Butylated Hydroxytoluene (BHT), Propyl Gallate, and a-Tocopherol (VitE).
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What are some examples of Chelating agent antioxidants?
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Edtic Acid and Disodium Edetate (EDTA).
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What are some examples of Adjunctive agent antioxidants?
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Citric Acid & Tartaric Acid
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How do chelating agents serve as antioxidants?
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They bind transitional metals that catalyze oxidative processes.
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What are some characteristics of Ascorbic Acid (VitC) as an antioxidant?
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Soluble in water and alcohol, non-toxic, effective at low concentrations, practically insoluble in vegetable oils, has a sour/acid taste, solutions have a pH 2-3, and it darkens as it oxidizes.
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Where is ascorbic acid commonly used as an antioxidant?
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In food and pharmaceuticals where an acidic pH is not a problem.
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What are some characteristics of sodium bisulfite as an antioxidant?
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Soluble in water and alcohol, effective at low concentrations, has a foul odor and a disagreeable taste, solutions have an acidic pH, oxidezes as it is exposed to air realeasing SO2, caution for sulfite allergies.
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Where is sodium bisulfite commonly used as an antioxidant?
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Commonly used in foods, especially wine, but the products must be labled with a warning for those who are hypersensitive or may have asthma. Warning not required on pharmaceuticals, but...
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What are some characteristics of sodium thiosulfate as an antioxidant?
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Very soluble in water, insoluble in ethanol, effective at low concentrations, colorless, odorless, tasteless, solutions have a pH 6.5-7, not a sulfite, may release or absorb water.
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Is sodium thiosulfate commonly used in foods and pharmaceuticals?
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Yes
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What are some characteristics of ascorbyl palmitate as an antioxidant?
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Effective at low concentrations, slightly soluble in water and oils, but soluble in ethanol, slightly sour taste, is a fusion of ascorbic acid and palmitic acid
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Is ascorbyl palmitate commonly used in foods and pharmaceuticals?
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No, it is a prototype only since it is not effectively soluble in common vehicles.
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What are some characteristics of BHA/BHT as antioxidants?
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Insoluble in water, but soluble in fats,oils, etc., effective at low concentrations, faint odor, tasteless, BHA listed as potential carcinogen.
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Where are BHA/BHT commonly used as an antioxidant?
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In foods and cosmetics.
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What are some characteristics of propyl gallate as an antioxidant?
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Soluble in alcohol and oils, only lightly soluble in water, effective at low concentrations, solutions have a pH of 6.5-7, has only a slight odor, tasteless, may have possible antimicrobial activity.
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Where is propyl gallate commonly used as an antioxidant?
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In foods and cosmetics. Is synergistic with BHA/BHT.
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What are some characteristics of a-Tocopherol (VitE) as an antioxidant?
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Miscible with alcohol and oils, effective at low concentrations, odorless, tasteless, thermodynamically stable, but sensitive to light.
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Where is a-Tocopherol (VitE) commonly used as an antioxidant?
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Due to its public popularity, it is frequently used in foods and cosmetics.
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What are some characteristics of Edetic Acid as an antioxidant?
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It is not too soluble in water, effective at low concentrations, solutions have a pH of 2.2.
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Blending of powders by pharmaceutical manufacturers is:
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Usually achieved by sifting and layering of powders in a large tumbler.
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Bulk powders for external use:
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Commonly use diluents such as corn starch and talc.
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Bulk powders for internal use are compounded infrequently because:
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The pharmacist must calibrate the dosing utensil (spoon, scoop) to properly dispense the product.
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What is the maximum length for beyond use date of a repackaged prescription drug product dispensed by a pharmacist (in months)?
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12
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What is the maximum length for beyond use date of a compounded non-aqueous liquid or powder dosage form (in months)?
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6
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To verify your accuracy in preparing this Rx, your pharmacist-supervisor wants you to prove you meet USP compounding standards. You will meet these standards for capsules if:
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The capsule weights are within 15% of the calculated weight and the RSD is less than or equal to 6%.
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Which of the following ingredients would be considered a "glidant" in a tablet formation:
Magnesium stearate Mannitol Talc |
Talc
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A final step in the tabletting process is tablet coating. Tablet coating:
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is often used to prevent tablet cracking or breaking during the packaging process.
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Tablet performance evaluation includes parameters for content uniformity that:
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Evaluate tablet weight if the active ingredients are more than 50% of the total tablet content.
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What is the maximum number of capsules in a sample batch that can exceed 25% of the calculated weight using USP guidelines?
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0
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Tonicity adjustment is frequently necessary for solution dosage forms intended for use in which of the following:
Nasally Orally Otically |
Nasally
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Which of the following statements is true?
Surfactants may be used for opthalmic solutions. Viscosity enhancers are often used for otic preparations. Sterile purified water should be used by pharmacists when preparing IV admixtures. |
Viscosity enhancers are often used for otic preparations.
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Dehydrated alcohol for injection:
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Must meet additional standards for pyrogen and particulate content.
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Glycerin and propylene glycol have many similar, yet important unique properties that provide pharmacists flexibility in preparing pharmaceutical products. For example:
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Propylene glycol has the ability to dissolve volatile oils.
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Barriers to achieving true "24 hour drug delivery" using an oral dosage form include:
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Varying composition of the GI tract fluids.
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What are some common characteristics of 2Na EDTA?
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It is soluble in water, effective at low concentrations, solutions have a pH of 5.
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Where are Edetic Acid/2Na EDTA commonly used as antioxidants?
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They are used in pharmaceuticals and in foods.
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What are some common characteristics of Citric Acid & Tartaric acid as antioxidants?
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Very soluble in water and in ethanol, effective in very low concentrations, strong acid/tart taste.
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Where are Citric Acid & Tartaric acid used as antioxidants?
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They are not. They are most commonly used as buffers.
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What defines a preservative?
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They are antimicrobial agents added to pharmaceuticals to protect the product from microbial growth that may inadvertantly be added to a product during manufacturing or compounding.
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What are preservatives not good substitutes for?
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They are not substitutes for good manufacturing processes.
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Do preservatives render a product sterile?
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No.
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Preservatives are required for dosage forms that contain _______ and are intended to deliver (a) ________ dose(s) of medication.
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water; multiple
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Which type of dosage form requires a preservative whether it is aqueous or not?
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Opthalmalic ointments.
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When are preservatives not required?
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If the dosage form is single use, intended to be used immediately, if no water is present, if the pH is less than 3 or greater than 9, or if the AI itself is an antimicrobial agent.
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When do you specifically NOT use preservativis?
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Preparations for neonates, opthalmalic solutions used during eye surgery, or parenteral products with a volume greater than 30mL.
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What are some ideal properties of preservatives?
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Effective at low, non-pharmacologically active concentrations, Stable and effective over pH range of 3-9, stable and effective over wide temperature ranges, be soluble in common vehicles at effective concentrations, be compatible with a variety of drugs and containers, be free from objectionable taste, odor, and color, and finally, to be non-sensitizing
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What are some examples of preservatives?
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Ethanol, propylene glycol, glycerin, benzyl alcohol, benzoic acid, sorbic acid, parabens, mercurials, and quaternary amines.
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How would you basically define a buffer?
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Compounds, especially mixtures of compounds, added to a pharmaceutical product to resist changes in pH when small quantities of acid or base are added to the solution.
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Especially in pharmaceutical products, what is our focus with buffers?
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Our focus is to render the product more compatible with tissue, to retard oxidation, to gain a solubility advantage, and to influence the products absorption.
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What are the three major buffer systems used in pharmaceuticals?
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Acid buffers, Physiological buffers, and Alkaline buffers
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What are two examples of an acid buffer?
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The citric acid --> sodium citrate system (pH range: 2.1-5.8)
The acetic acid --> sodium acetate system (pH range: 3.6-5.8) |
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What is an example of a physiological buffer?
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The H2PO4 --> HPO4 system (pH range: 5.6-8.0)
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What is an example of an alkaline buffer?
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The NH4OH --> NH4Cl system (pH range: 8-10.5)
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What is the Henderson-Hasselbach equation?
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pH = pKa + log [conjugate base]/[conjugate acid]
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When the buffer is a weak acid, which is the un-ionized portion and which is the salt? (Conjugate acid, conjugate base)
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The acid is un-ionized, the conjugate base is the salt
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When the buffer is a weak base, which is the un-ionized portion and which is the salt? (Conjugate acid, conjugate base)
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The base is unionized, the conjugate acid is the salt
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When you are calculating the amount of acid/base to use in a buffer, you find your answer in terms of a ratio, or in a number of parts. How much exactly is a part?
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Depending on the buffering capacity necessary, we would like the total buffer concentration to be 1/2 the concentration of the AI, but no less than 0.05M.
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When do you use coloring in a pharmaceutical preparation?
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To match a flavor used in an oral product, or in topical preparations to match skin tones.
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Why are colors not to be used?
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To mask poor quality products.
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Why do you use a coloring agent in a pharmaceutical preparation?
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To improve patient compliance (adherance), to complement flavors, to appeal to consumers, or to disguise topical products.
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What are some natural dyes?
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Ferric Oxide, Titanium dioxide, carbon, indigo, saffron, beta-carotene
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What are synthetic dyes made from?
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Chromophores.
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Where do chromophores come from?
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Pi bonds and/or metal complexes.
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How are synthetic dyes historically synthesized?
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From aniline, a coal tar extract.
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What are the rules to follow when using coloring agents?
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They should be non-toxic, non pharmacological, and should follow the FDAs regulations for use.
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What legal statuses of coloring agents exist?
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FD&C, D&C, External D&C
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What things about a product may effect a dye's stability?
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pH, Oxidizers, and light exposure
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About how much dye is required to color a pharmaceutical product?
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Liquids require about 0.0001% concentration of dye, while pastes require about 0.1% concentration of dye.
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What is a 'taste' composed of?
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Smell, sight, touch, and flavor
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What are the main taste sensations?
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Sweet, sour, salty, and bitter.
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Which one of the taste sensations are most objectionable?
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Bitter
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What is the newest taste sensation that is just now sweeping the nation?
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UMAMI, or savoriness
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What is savoriness the perception of?
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L-glutamate
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Why do we add flavors to a product?
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To improve patient compliance (adherance), to mask unpleasant tastes, to appeal to the consumer, to make products more palatable for animals.
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What are the three major types of flavoring?
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Natural flavoring, Artificial flavoring, and spices
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What are natural flavors?
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The substance of a natural source whose significant function is flavor rather than nutrition.
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What are artificial flavors?
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Usually synthetic flavors, not from a natural source.
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What are spices?
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An aromatic vegetable substance.
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What are some commercial flavor designations?
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Natural flavor, Natural & Artificial Flavors, With other natural flavors, or Artificial Flavors
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What chemical compounds are sweet? Give some examples.
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Low molecular weight polyhydroxyls. Sucrose, sorbitol, mannitol
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What chemical compounds are sour? Give some examples.
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Free H+ ions. Acids, phenols, tannins, and lactones.
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What chemical compounds are salty? Give some examples.
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Inorganic low molecular weight salts. Ammonium chloride, and K+-gluconate.
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What chemical compounds are bitter? Give some examples.
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Free OH- ions. Diphenhydramine, caffeine, codeine
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What is blending?
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The use of a couple complementary flavors to improve palatability, like as in chocolate-orange combination.
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What is flavor masking?
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The covering of the active ingredient taste with an intense and long lasting taste like wintergreen or peppermint.
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What are some physical methods of flavoring?
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Making an oil-in-water emulsion and flavor the aqueous phase, use effervescent additives, or increase the viscosity.
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What type of flavors would you use to mask sour tastes?
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Cherry, pineapple, raspberry, citrus
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What type of flavors would you use to mask sweet tastes?
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Berry, vanilla, fruity
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What type of flavors would you use to mask salty tastes?
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Citrus, cinnamon, chocolate
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What type of flavors would you use to mask bitter tastes?
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Chocolate, raspberry, licorice, cherry
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What type of flavors would you use to mask acidic tastes?
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Citrus
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What type of flavors would you use to mask an aftertaste?
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Peppermint, wintergreen, licorice, vanilla, marshmallow
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Why add sweeteners to a product?
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To improve patient compliance (adherance), to enhance flavors, and to appeal to consumers
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What are some desirable properties of sweeteners?
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Colorless, odorless, water soluble, pleasant taste, no aftertaste, thermally stable, pH stable, Non-carcinogenic, non-toxic
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What are some examples of sweeteners?
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Sucrose, sorbitol, mannitol, saccharin, aspartame,
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What are some characteristics of sucrose?
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Very soluble in water, has caloric load, affects blood sugar, may result in dental cavities.
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What are some characteristics of sorbitol?
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Not as sweet as sugar, very soluble in water, may result in diarrhea, is hygroscopic.
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What are some characteristics of mannitol?
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Not as sweet as sugar, isomer of sorbitol, non-hygroscopic, may result in diarrhea, is an osmotic diuretic.
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What are some characteristics of saccharin?
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Very much sweeter than sugar, not as soluble in water, but the sodium form is water soluble, has a bitter aftertaste, may be carcinogenic.
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What are some characteristics of aspartame?
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Much sweeter than sugar, is a combination of two amino acids (L-aspartic acid, and L-phenylalanine) in a methyl ester form. Not thermodynamically stable, not suitable for phenylketonuriacs.
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An increase in viscosity has what effect on overall taste?
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A decrease.
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A decreased temperature (increases or decreases) tasting.
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Decreases
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Does on effervescent sensation mask tastes?
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Yes
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Does sweetening bring out flavoring?
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Yes
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Small amount of anesthetizing agents in a product may do what?
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They may mask some taste.
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What is tonicity?
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A colligative property describing the number of solute particles in solution.
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What is the significance of tonicity?
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The movement of fluid in or out of cells is dependent upon the number of solute particles on either side of the cell membrane.
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What happens when you place a hypotonic solution on tissue/cells?
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Fluid will move into the tissues and cause swelling.
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What happens when you place a hypertonic solution on tissue/cells?
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Fluid will move out of the tissues and cause shrinking.
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In pharmaceutical products, how do we focus on tonicity?
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We want to render the products compatabile with tissue, especially the opthalmalic, parenteral, and irrigative products.
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What concentrations of a saline or dextrose solution are considered isotonic?
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0.9% saline, or 5% dextrose.
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What are the three primary techniques in predicting isotonicity needs?
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NaCl equivalent method, Freezing point depression method, or the White & Vincent (USP) system
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What is the NaCl equivalent method?
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0.9% Saline is defined as isotonic, and all other solutes are referenced by the degree to which they dissociate to NaCl.
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What is the Freezing Point depression method?
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0.9% Saline is defined as depressing the freezing point by 0.52 degrees celcius, and all other solutes are referenced by the degree to which they depress the freezing point.
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What is is the White & Vincent (USP) method?
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A variant of the NaCl equivalent method, but it focuses on the amount of water to add to qs the total preparations volume.
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