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Questions and Answers
What is the primary purpose of Purified Water, USP?
What is the primary purpose of Purified Water, USP?
- To prepare aqueous dosage forms (correct)
- To provide drinking water for pharmaceutical staff
- To disinfect tools used in pharmaceutical manufacturing
- To be used in parenteral injections
Which of the following methods of purification results in water that is considered demineralized or deionized?
Which of the following methods of purification results in water that is considered demineralized or deionized?
- Chlorination
- Ultraviolet light treatment
- Reverse osmosis (correct)
- Simple filtration
What distinguishes Water for Injection, USP from Purified Water, USP?
What distinguishes Water for Injection, USP from Purified Water, USP?
- Water for Injection contains added substances
- Water for Injection must be sterile (correct)
- Water for Injection requires no processing
- Water for Injection is derived from tap water
What is the maximum permissible concentration of total solids in Water for Injection, USP?
What is the maximum permissible concentration of total solids in Water for Injection, USP?
Which component is specifically removed by the reverse osmosis process?
Which component is specifically removed by the reverse osmosis process?
Which of the following statements correctly describes the solubility behavior of weak bases in acidic solutions?
Which of the following statements correctly describes the solubility behavior of weak bases in acidic solutions?
What happens to weak acids when the pH of their solution is decreased?
What happens to weak acids when the pH of their solution is decreased?
Which ionic compound is likely to be insoluble in water based on the solubility rules?
Which ionic compound is likely to be insoluble in water based on the solubility rules?
According to the general rules of solubility, which of the following compounds is an exception to the solubility of sulfates?
According to the general rules of solubility, which of the following compounds is an exception to the solubility of sulfates?
Which compound would typically be classified as water soluble?
Which compound would typically be classified as water soluble?
Which statement about the solubility of hydroxides is true?
Which statement about the solubility of hydroxides is true?
Which category of compounds is generally not soluble in water according to the provided solubility rules?
Which category of compounds is generally not soluble in water according to the provided solubility rules?
What effect does increasing the pH have on the solubility of weak bases?
What effect does increasing the pH have on the solubility of weak bases?
Which of the following pairs contains compounds that are both generally water soluble?
Which of the following pairs contains compounds that are both generally water soluble?
What is the primary purpose of pharmaceutical excipients in dosage forms?
What is the primary purpose of pharmaceutical excipients in dosage forms?
Which of the following is NOT classified as a solid dosage form?
Which of the following is NOT classified as a solid dosage form?
Enteric-coated tablets are specifically designed to:
Enteric-coated tablets are specifically designed to:
Which of the following is an example of a biphasic liquid dosage form?
Which of the following is an example of a biphasic liquid dosage form?
What role do stabilizers serve in pharmaceutical formulations?
What role do stabilizers serve in pharmaceutical formulations?
Which of the following dosage forms is classified as one unit solid?
Which of the following dosage forms is classified as one unit solid?
Why are flavored syrups often used in oral dosage forms?
Why are flavored syrups often used in oral dosage forms?
What is a liquid dosage form that is characterized as monophasic?
What is a liquid dosage form that is characterized as monophasic?
Which solubility factor suggests that molecules with branched chains are more soluble than their straight-chain counterparts?
Which solubility factor suggests that molecules with branched chains are more soluble than their straight-chain counterparts?
Which solvent, when combined with water, creates a hydroalcoholic mixture capable of dissolving both alcohol-soluble and water-soluble substances?
Which solvent, when combined with water, creates a hydroalcoholic mixture capable of dissolving both alcohol-soluble and water-soluble substances?
What property of water makes it the preferred solvent in many pharmaceutical preparations?
What property of water makes it the preferred solvent in many pharmaceutical preparations?
What effect does an increase in molecular weight generally have on the solubility of organic compounds?
What effect does an increase in molecular weight generally have on the solubility of organic compounds?
Which of the following solvents is considered toxic for internal pharmaceutical preparations?
Which of the following solvents is considered toxic for internal pharmaceutical preparations?
What is the primary use of Isopropyl Rubbing Alcohol in pharmaceutical applications?
What is the primary use of Isopropyl Rubbing Alcohol in pharmaceutical applications?
Which of the following characteristics should a suitable solvent possess for pharmaceutical formulations?
Which of the following characteristics should a suitable solvent possess for pharmaceutical formulations?
Which of these is a characteristic of Glycerin as a solvent?
Which of these is a characteristic of Glycerin as a solvent?
Which alkali metal salts are typically exceptions in terms of the solubility of phosphates?
Which alkali metal salts are typically exceptions in terms of the solubility of phosphates?
In the context of organic molecules, how does structural similarity between the solute and solvent influence solubility?
In the context of organic molecules, how does structural similarity between the solute and solvent influence solubility?
What is the main purpose of using suspensions in pharmaceutical preparations?
What is the main purpose of using suspensions in pharmaceutical preparations?
How are the attractive forces in molecules described when they reach a stable state?
How are the attractive forces in molecules described when they reach a stable state?
What characterizes a saturated solution at a given temperature?
What characterizes a saturated solution at a given temperature?
Which type of dosage form provides an optimal drug action through inhalation therapy?
Which type of dosage form provides an optimal drug action through inhalation therapy?
What distinguishes potassium iodide oral solution from calcium hydroxide topical solution in terms of solute concentration?
What distinguishes potassium iodide oral solution from calcium hydroxide topical solution in terms of solute concentration?
Which term describes the forces that must be overcome when a solute dissolves in a solvent?
Which term describes the forces that must be overcome when a solute dissolves in a solvent?
Which of the following is NOT a form of drug administration mentioned?
Which of the following is NOT a form of drug administration mentioned?
What is the effect of dipole-dipole forces in molecular interactions?
What is the effect of dipole-dipole forces in molecular interactions?
Which method of drug delivery involves placing drugs directly in the bloodstream?
Which method of drug delivery involves placing drugs directly in the bloodstream?
What process occurs when solid solute is shaken with solvent until no more can dissolve?
What process occurs when solid solute is shaken with solvent until no more can dissolve?
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Study Notes
Pharmaceutical Dosage Forms
- Pharmaceutical dosage forms are combinations of drug substances and non-medicinal agents, known as excipients.
- Excipients enhance the properties of drugs, aiding in solubilization, suspension, thickening, dilution, emulsification, stabilization, preservation, and aesthetic appeal.
Types of Dosage Forms
- Liquid Dosage Forms
- Monophasic (single phase):
- Solutions — homogenous mixtures of solute(s) dissolved in a solvent.
- Syrups — concentrated aqueous solutions of sugar, often used for oral administration.
- Biphasic (two phases):
- Suspensions — solid particles dispersed within a liquid.
- Emulsions — liquid droplets dispersed within another liquid.
- Monophasic (single phase):
- Solid Dosage Forms
- One Unit:
- Tablets — compressed solid dosage forms containing drug and excipients.
- Capsules — solid dosage forms where the drug is enclosed in a shell, usually made of gelatin.
- Bulk:
- Powder — finely divided solid particles that are typically mixed with a liquid before administration.
- Granules — small, irregular particles of drug and excipients.
- Dusting Powder — finely divided powder applied topically.
- One Unit:
- Semisolid Dosage Forms
- Gel — homogenous mixture of drug dispersed in a semi-solid matrix.
- Paste — thick semisolid formulation containing a high concentration of solid particles.
- Cream — emulsion of oil and water, containing a drug.
- Ointment — thick, greasy preparation for topical application.
- Gas Dosage Forms
- Inhaler — device delivering a drug in the form of a gas or fine mist.
- Aerosols — pressurized containers releasing a drug in the form of a fine mist.
Why Are Drugs Formulated as Dosage Forms
- To provide safe and convenient administration of accurate dosages.
- To protect drugs from environmental factors like oxygen and humidity.
- To protect drugs from degradation in the stomach.
- To mask unpleasant tastes or odors.
- To enable liquid preparations of poorly soluble drugs.
- To create clear liquid dosage forms.
- To control the rate of drug release.
- To optimize drug action from topical applications.
- To administer drugs into body cavities like the rectum or vagina.
- To administer drugs directly into the bloodstream or tissues.
- To optimize drug action through inhalation therapy.
Solubility
- Solubility refers to the ability of a solute to dissolve in a solvent.
- Saturated solution: a solution where the solvent has dissolved the maximum amount of solute at a given temperature.
- Factors influencing solubility include:
- Attractive forces between molecules (dipole-dipole, Van der Waals forces, hydrogen bonding)
- The balance between solute-solute, solute-solvent, and solvent-solvent interactions.
- Example:
- Calcium hydroxide is poorly soluble in water (140 mg/100 mL at 25°C), while potassium iodide is highly soluble (100 g/100 mL).
General Rules of Solubility
Inorganic Molecules
- Monovaelnt ions (e.g., NaCl, KI): generally water soluble.
- One monovalent and one multivalent ion (e.g., BaCl2, Na2SO4): generally water soluble.
- Multivalent ions (e.g., CaSO4, BaSO4): generally poorly water soluble.
- Alkali metal salts (Na, K, Li, Cs, Rb): usually water soluble (except Li2CO3).
- Ammonium and quaternary ammonium salts: water soluble.
- Nitrates, nitrites, acetates, chlorates, and lactates: generally water soluble (exceptions: silver and mercurous acetate).
- Sulfates, sulfites, and thiosulfates: generally water soluble (exceptions: calcium and barium salts).
- Chlorides, bromides, and iodides: water soluble (exceptions: salts of silver and mercurous ions).
- Acid salts: more water soluble than their corresponding insoluble salts.
- Hydroxides and oxides: generally water insoluble except for alkali metal cations and ammonium.
- Sulfides: water insoluble except for alkali metal salts.
- Phosphates, carbonates, silicates, borates, and hypochlorites: water insoluble except for alkali metal and ammonium salts.
Organic Molecules
- One polar functional group: generally soluble up to a chain length of five carbons.
- Branched chains: more soluble than straight chains.
- Solubility decreases with increasing molecular weight.
- Similar structures between solute and solvent: increase solubility.
Official Solvents
- Alcohol, USP (Ethyl Alcohol, Ethanol): a primary solvent for many organic compounds.
- Diluted Alcohol, NF: mixture of alcohol and purified water.
- Alcohol, Rubbing: contains approximately 70% ethyl alcohol, used externally as a rubefacient.
- Glycerin, USP (Glycerol): thick, syrupy liquid, used as a stabilizer, preservative, and auxiliary solvent.
- Propylene Glycol, USP: viscous liquid frequently substituted for glycerin.
- Isopropyl Rubbing Alcohol: used externally for its rubefacient and soothing properties.
- Purified Water, USP: purified water, mainly used for aqueous dosage forms excluding those for parenteral administration.
- Methods of preparation:
- Distillation: heating water to vapor and collecting condensate.
- Ion Exchange: passing water through columns of cation and anion exchangers.
- Reverse Osmosis (RO): forcing water through a membrane to remove impurities.
- Methods of preparation:
Solvents and Vehicles For Injections
- Water for Injection, USP: the most commonly used solvent for injections. Must be pyrogen-free.
- Bacteriostatic Water for Injection, USP: sterile water containing a bacteriostatic agent.
- Sterile Water for Injection, USP: sterilized water for injection but does not contain additives.
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