Learn More About Pharmaceutics - Pharmaceutics Review Quiz

The statement is true because Clarithromycin for Oral Suspension comes in a powder form that needs to be mixed with a specific amount of water before it can be taken by the patient. This reconstitution process ensures that the medication is properly prepared and the correct concentration is achieved. The pharmacist is responsible for accurately measuring and mixing the powder and water to create the suspension, which can then be dispensed to the patient.

Amorphous forms of a compound lack a regular, ordered structure, which allows for greater molecular mobility and increased contact between the compound and the solvent. This increased contact leads to a higher solubility and faster dissolution rate compared to crystalline forms, which have a more rigid and organized structure. Therefore, the statement that amorphous forms of a compound are typically more soluble and have a faster dissolution rate than crystalline forms is true.

The explanation for the given correct answer is that the statement is true because it states that Diazepam, the active pharmaceutical ingredient in Valium Injection 5mg/mL, is "insoluble" in water at 25°C. This means that it requires more than 10,000ml of water to dissolve 1g of diazepam at that temperature. Therefore, the statement is accurate and the answer is true.

Soft gelatin capsules are commonly used to encapsulate drugs that are dissolved in oily solutions. The gelatin shell of the capsule is designed to dissolve in the gastrointestinal (GI) fluid, allowing the drug to be released and dissolved in the fluid as well. This dissolution is necessary for the drug to be absorbed into the bloodstream from the tablet dosage form. Therefore, the statement that a drug must first dissolve in the GI fluid before absorption from a soft gelatin capsule can occur is true.

The statement is true because HPMCAS is indeed the enteric polymer used on both Strattera and Cymbalta. Enteric polymers are used in pharmaceutical formulations to protect drugs from degradation in the acidic environment of the stomach and to ensure targeted release in the intestine. HPMCAS (hydroxypropyl methylcellulose acetate succinate) is a commonly used enteric polymer that provides delayed release properties. Therefore, it is plausible that both Strattera and Cymbalta, which are oral medications, would utilize HPMCAS as the enteric polymer for controlled release in the gastrointestinal tract.

The statement is true because the Hatch-Waxman Act indeed establishes the procedure for generic drug manufacturers to submit abbreviated new drug applications (ANDAs) to the FDA and obtain approval for their generic products. This act was enacted in 1984 to encourage the production of affordable generic drugs while still protecting the rights of innovator drug companies. It created a streamlined process for generic drug approval, allowing for faster market entry and competition, ultimately benefiting consumers by providing more affordable medication options.

The anhydrous form of drugs such as ampicillin is more soluble and dissolves at a faster rate compared to the trihydrate form. This means that the anhydrous form is more easily absorbed by the body and has a higher bioavailability. Therefore, the statement is true.

Dry powder inhalers (DPIs) require patients to inhale forcefully to effectively deliver the medication. However, the effectiveness of DPIs is highly dependent on the patient's inspiratory flow rate. If the flow rate is too low, the medication may not be properly dispersed and may not reach the lungs. This can result in inadequate dosing and reduced therapeutic efficacy. Therefore, it is true that one of the disadvantages of dry powder inhalers is the dependence of dose delivery on patient inspiratory flow rates.

Plastic flowing liquids exhibit a yield value when shear stress is plotted on the Y-axis and shear rate is plotted on the X-axis. This means that there is a minimum amount of stress required for the liquid to start flowing. Additionally, plastic flowing liquids are elastic below the yield value, which means they can return to their original shape after being deformed as long as the stress applied is below the yield value. Therefore, the statement is true.

The given statement suggests that Vibramysicn Oral Suspension contains doxycycline calcium and sodium carboxymethylcellulose as an excipient. It further states that sodium carboxymethylcellulose is employed as a suspending agent and thickening agent in the suspension. Therefore, the statement is true as it indicates the purpose of sodium carboxymethylcellulose in the oral suspension.

The slugging or recompression method of tablet manufacture involves compressing a mixture of drug and excipients into large tablets, which are then crushed into granules and compressed again into smaller tablets. This method is suitable for drugs that are unstable in the presence of moisture because it allows for the incorporation of moisture-sensitive drugs into the tablet formulation without exposing them to excessive moisture during the manufacturing process. Therefore, the statement "The slugging or recompression method of tablet manufacture can be used to make tablets containing drugs that are unstable in the presence of moisture" is true.

Granules are formed when small particles come together and agglomerate, creating irregular shapes. Despite their irregularity, granules often behave as a single large particle due to the cohesive forces between the small particles. This behavior is observed in various industries, such as pharmaceuticals and food processing, where granules are commonly used. Therefore, the statement "Granules are irregular agglomerates of small particles which behave as a single large particle" is true.

Hydrochloride salts are commonly used in commercial drug products due to their stability and solubility properties. They are formed by combining an active pharmaceutical ingredient with hydrochloric acid, resulting in a salt form that is easier to handle and administer. This salt form enhances the drug's bioavailability and allows for better control of dosage. Therefore, it is true that hydrochloride salts are the most common salts found in commercial drug products.

The statement is true because buccal delivery of fentanyl citrate through Actiq bypasses first pass metabolism. First pass metabolism refers to the breakdown and alteration of a drug by the liver before it enters the systemic circulation. When a drug is administered orally, it passes through the gastrointestinal tract and is metabolized by the liver before reaching the bloodstream. However, when fentanyl citrate is delivered buccally through Actiq, it is absorbed directly into the bloodstream through the buccal mucosa, bypassing the liver and thus avoiding first pass metabolism. This results in a higher bioavailability of the drug compared to oral administration.

The rate of settling of a dispersed drug in an aqueous vehicle is increased as the diameter of the drug is increased. This is because larger drug particles have a greater mass and therefore experience a higher gravitational force, causing them to settle more quickly. Additionally, larger particles have a higher surface area, which allows for more interactions with the surrounding liquid and aids in the settling process. Therefore, it is true that the rate of settling is increased as the diameter of the drug is increased.

Thermogravimetric analysis (TGA) is a reliable technique used to analyze the thermal stability and composition of a substance. It measures the change in weight of a sample as it is heated, providing information about the presence of water or other volatile components. By subjecting a compound to TGA, it is possible to differentiate between the dihydrate form (containing water molecules) and the anhydrous form (without water molecules). Therefore, the statement that TGA is an excellent method to determine if a compound is in the dihydrate form or the anhydrous form is true.

The given answer is true because when the contents of Alprazolam capsules are mixed with Simple Syrup NF, the resulting product is a suspension. This is because Alprazolam has a low solubility in water (45 mcg/mL) and a higher solubility in ethanol (>20 mg/mL), indicating that it does not dissolve completely in water. Therefore, when mixed with Simple Syrup NF, the Alprazolam particles will remain suspended in the liquid, creating a suspension rather than a solution.

The given statement is true because when fenofibrate was administered orally as an aqueous suspension using the DissoCube method, it resulted in the formation of 338nm diameter particles of fenofibrate. These particles had a higher dissolution rate and bioavailability compared to fenofibrate formulated as a microsuspension in a vehicle containing 0.4% HEC 400 in NS. Therefore, the DissoCube method proved to be more effective in improving the dissolution and bioavailability of fenofibrate.

Absorption ointment bases like Hydrophilic Petrolatum are anhydrous, meaning they do not contain water, and are not soluble in water. However, they have the ability to absorb water and form an emulsion. This means that when these ointment bases come into contact with water, they can absorb the water molecules and create a mixture where the water is dispersed throughout the ointment. Therefore, the statement "Absorption ointment bases, such as Hydrophilic Petrolatum, are anhydrous and not soluble in water, but can absorb water to form an emulsion" is true.

Buffering agents are substances that help maintain a stable pH in a solution by resisting changes in acidity or alkalinity. Citric acid is commonly used as a buffering agent in aqueous suspension vehicles because it can effectively control and maintain the pH of the suspension. Therefore, the statement that typical buffering agents used to control the pH of an aqueous suspension vehicle include citric acid is true.

The rate of dissolution of a drug that is classified as "insoluble" in water is dependent on the agitation conditions being used to dissolve the drug. Agitation helps to increase the contact between the drug particles and the water, allowing for a faster dissolution process. Without agitation, the drug particles would remain suspended in the water, resulting in a slower dissolution rate. Therefore, the statement is true.

Glycerin and propylene glycol are both miscible with water and ethanol at room temperature because they have similar polarities and intermolecular forces. Miscibility refers to the ability of two substances to mix together in any proportion to form a homogeneous solution. Glycerin and propylene glycol have polar functional groups, which allow them to form hydrogen bonds with water and ethanol molecules. This enables them to dissolve and mix well with these substances, resulting in a homogeneous solution at room temperature.

Patients should not take an antacid product along with an enteric coated tablet because antacids can neutralize the stomach acid, which is necessary for the enteric coating to dissolve and release the medication properly. Enteric coated tablets are designed to pass through the stomach and dissolve in the intestines, where they can be absorbed. Taking an antacid along with an enteric coated tablet can interfere with the intended release and absorption of the medication, reducing its effectiveness. Therefore, it is recommended to avoid taking antacids at the same time as enteric coated tablets to ensure proper drug delivery.

The explanation for the given correct answer is that Sporanox capsules do not have a sustained release formulation for the active ingredient, Itraconazole. This means that the coated beads in the capsules do not release the active ingredient slowly over time, but instead release it all at once. Therefore, the statement "Sporanox capsules contain coated beads that are not formulated to sustain the release of the active ingredient (Itraconazole)" is true.

The explanation for the given correct answer is that the Streisand Study showed that the nonionized fraction of fentanyl citrate absorbed buccally (through the cheek) increased with higher pH levels. This means that when the pH is higher, more of the fentanyl citrate is absorbed. Fentora and Actiq are both buccal drug delivery systems used to deliver fentanyl citrate. Therefore, it is true that Fentora and Actiq are both buccal drug delivery systems for fentanyl citrate.

Deliquescent drugs are substances that have a tendency to absorb moisture from the air and dissolve in it. Formulating these drugs into hard gelatin capsules can lead to the capsules becoming soft, deformed, or even dissolving completely due to the moisture absorption. Therefore, it is not recommended to use hard gelatin capsules for deliquescent drugs.

Drugs are typically less stable in aqueous solution than when stored in the dry state.

Omeprazole is unstable in acid media because it is a proton pump inhibitor that works by reducing the production of stomach acid. It is designed to be stable in the neutral pH of the bloodstream, but in the acidic environment of the stomach, it can degrade and lose its effectiveness. This is why omeprazole is typically formulated in enteric-coated tablets, which protect it from the acidic conditions of the stomach and allow it to reach the intestines where it can be absorbed and work effectively.

Soft gelatin capsules are designed to deliver drugs that are poorly soluble in water. The gelatin shell of the capsule is permeable to lipid-based vehicles, such as Miglyol 812, peanut oil, and castor oil, which can dissolve the drug and facilitate its absorption. Polyethylene glycol can also be used as a vehicle in soft gelatin capsules. However, purified water cannot be used as a vehicle in soft gelatin capsules as it is highly soluble in water and would cause the gelatin shell to dissolve, resulting in the leakage of the drug and loss of its therapeutic effect.

Comminution is actually a process that involves reducing the size of solid materials into smaller particles. It is commonly used in the pharmaceutical industry to enhance the dissolution rate and bioavailability of drugs. It does not protect the drug from being degraded in the presence of light and moisture. Therefore, the given statement is false.

Formulating drugs into granules for reconstitution by the pharmacist is not primarily done to decrease costs by eliminating water from the product. The main reason for this formulation is to increase the stability and shelf life of the drug, as well as to improve its dissolution and absorption in the body. By formulating drugs into granules, they can be stored in a more stable and compact form, and then reconstituted with water when needed. This allows for easier storage, transportation, and administration of the drug.

Protein and peptide drugs are typically more stable when stored in a refrigerator at 5°C rather than at room temperature. Cold temperatures help to slow down the degradation and decomposition processes that can occur in these drugs, thereby preserving their stability and efficacy. Storing them at room temperature may lead to a faster breakdown of the drugs, reducing their effectiveness. Therefore, the statement that protein and peptide drugs are more stable at room temperature is incorrect.

The Noyes-Whitney equation does not describe the relationship between shear stress and shear rate. It is actually used to calculate the rate of dissolution of a solid in a solvent. Additionally, the viscosity of a Newtonian liquid is not constant at a given temperature. It can vary depending on factors such as pressure and composition. Therefore, the correct answer is False.

The statement suggests that the Pellicle effect is not a problem with HPMC, which implies that HPMC capsules do not experience the formation of a thin film on their surface. However, the answer states that the statement is false, indicating that the Pellicle effect can indeed occur with HPMC capsules. Additionally, the explanation mentions that drugs are generally more stable in aqueous solution than in the dry state, which is unrelated to the Pellicle effect and does not provide a clear explanation for the correct answer.

A ball mill is a type of grinder that is used to reduce the size of solid materials. By grinding the solid drug substance in a ball mill, it can be broken down into smaller particles, thereby increasing its surface area. This increased surface area can enhance the dissolution rate of the drug substance, as it allows for more efficient interaction with the surrounding medium. This is particularly useful for drugs that have poor solubility, as increasing the surface area can improve their bioavailability and therapeutic effectiveness.

The Noyes-Whitney equation is not used to determine the particle size of a drug as a function of temperature. Instead, it is an equation that relates the rate of dissolution of a solid drug in a solvent to various factors such as surface area, diffusion coefficient, and concentration gradient. It is commonly used in pharmaceutical sciences to study drug dissolution kinetics. Therefore, the statement that the Noyes-Whitney equation is a very effective method to determine the particle size of the drug as a function of temperature is false.

The statement is false because a major difference between ANDA (Abbreviated New Drug Application) and NDA (New Drug Application) is that ANDA does not require stability data on the finished product, while NDA does. Stability data is crucial in assessing the shelf life and quality of a drug product, so it is a requirement for NDA submissions but not for ANDA submissions.

Aspirin is the most stable drug in gastric juice. This is because aspirin is an acid-stable drug, meaning it can withstand the acidic environment of the stomach without breaking down or losing its potency. On the other hand, drugs like omeprazole, pantoprazole, and lansoprazole are proton pump inhibitors that work by reducing the production of gastric acid, while insulin is a protein-based drug that can be denatured and lose its effectiveness in the acidic environment of the stomach. Therefore, aspirin is the most stable option in gastric juice.

The solubility of fentanyl citrate in purified water at 37°C is greater than the solubility of fentanyl.

Sodium lauryl sulfate is a surfactant that is commonly used in pharmaceutical formulations to enhance drug dissolution rate. It acts by reducing the surface tension between the drug particles and the dissolution medium, thereby promoting the breakup of agglomerates and increasing the rate at which the drug dissolves. Additionally, sodium lauryl sulfate can offset the hydrophobic effects of lubricants, which can otherwise hinder drug dissolution. Therefore, the presence of sodium lauryl sulfate in a capsule formulation can help improve the dissolution properties of the drug.

Direct compression CAN"T be used for potent or low dose drugs

Eutectic formation occurs when two or more substances mix together to form a new compound with a lower melting point than any of the individual components. It is not related to the absorption of water into an excipient or the increase in the number of water molecules in a crystal. Therefore, the statement is false.

The rate of dissolution of 150 micron sized particles of Phenobarbital is actually greater than the rate of dissolution of 710 micron sized particles of Phenobarbital in water at 37°C.

The statement is false because the rate of dissolution of fentanyl citrate in a 50:50 v/v water:ethanol co-solvent at 25°C cannot be mathematically described by the Stokes Equation. The Stokes Equation is used to describe the settling velocity of particles in a viscous fluid, and it is not applicable to the dissolution rate of a substance in a solvent.

The statement is false because the organoleptic properties of a New Chemical Entity do not include solubility and stability. Organoleptic properties refer to the sensory properties of a substance, such as taste, smell, color, and texture. Solubility and stability are physical and chemical properties, respectively, and are not considered organoleptic properties.

Thermogravimetric analysis (TGA) is a technique used to measure the change in weight of a sample as it is heated or cooled. It is not specifically used to predict the solubility of drugs in GI fluid. Therefore, the statement is false.

Particles administered nasally are not cleared very slowly. Instead, they are cleared relatively quickly by mucociliary transport, usually within about 300 to 360 minutes. Therefore, the correct answer is false.

Enteric coated tablets are designed to bypass the stomach and dissolve in the small intestine. This allows the drug to be absorbed directly into the bloodstream from the small intestine, rather than being exposed to the acidic environment of the stomach. Therefore, the drug present in an enteric coated tablet is primarily absorbed in the small intestine, not the stomach.

Mucoadhesive agents are actually used in nasal spray formulations to increase the residence time of the drug in the nasal passageways, not to increase nasal clearance. These agents help the drug to adhere to the nasal mucosa, allowing for better absorption and prolonged drug release. Therefore, the statement is false.

The explanation for the answer "False" is that the ICH guidelines for stability testing of a new pharmaceutical product do not specifically require accelerated testing to be conducted at 40°C and 75% RH for a minimum of two years. While accelerated testing is commonly conducted at these conditions, the specific duration and conditions for stability testing may vary depending on the product and regulatory requirements. Therefore, the statement in the question is not entirely accurate.

Norvasc contains the salt form of amlodipine known as besylate. The besylate salt is commonly used in pharmaceutical formulations due to its stability and bioavailability. It helps in improving the solubility and absorption of amlodipine, making it an effective treatment for high blood pressure and angina.

Merck is not a generic pharmaceutical company because it primarily focuses on the development and manufacturing of branded prescription drugs. Unlike generic pharmaceutical companies that produce cheaper versions of brand-name drugs once the patent expires, Merck is known for its innovative and patented drugs. Therefore, Merck does not fall under the category of generic pharmaceutical companies.

The explanation for the answer "False" is that the statement claims that Fenofibrate formulated as a nanosuspension had equivalent dissolution and bioavailability compared to Fenofibrate formulated as a microsuspension. However, the answer is false because the statement does not provide any evidence or data to support this claim. Without any supporting information, it is not possible to conclude that the two formulations have equivalent dissolution and bioavailability.

Emulsions are thermodynamically unstable liquid preparations that require emulsifying agents, such as Tween 80, to decrease the interfacial tension between the two immiscible liquids and prevent them from separating. Therefore, the given statement is false.

Ethylcellulose is not an enteric polymer and does not begin to dissolve in the GI tract at pH 5.5. Enteric polymers are designed to withstand the acidic environment of the stomach and only dissolve in the more alkaline conditions of the small intestine. Ethylcellulose, on the other hand, is a non-enteric polymer that does not have this property. Therefore, the statement is false.

Ac-Di-Sol is not a superdisintegrant for tablets. It is actually a binder used in tablet formulations to improve the cohesion and strength of the tablets. It does not release carbon dioxide during the dissolution process. Therefore, the statement is false.

At the end of the clinical trials an NDA is submitted.

Enteric coating on NSAID protects patient in this case.

Drug dissolved in an aqueous vehicle is not susceptible to particle growth due to Ostwald ripening. Ostwald ripening is a process where larger particles grow at the expense of smaller particles in a solution. However, in an aqueous vehicle, the drug is typically in a dissolved form, meaning it is in molecular or ionized form and not as particles. Therefore, Ostwald ripening does not apply in this case, and the statement is false.

lactose and methylcrystal cellulose are the top 2 diluents

should be effervescent.

The given statement is false. Carbopol, carnuba wax, and hydroxypropyl cellulose are not hydrophilic materials that swell in the GI tract to release drugs from matrix tablets over an extended period of time. These materials are commonly used as excipients in pharmaceutical formulations, but they do not have the property of swelling in the GI tract. Instead, they are used for their binding, emulsifying, and stabilizing properties in tablet formulations.

drugs with a LOW therapeutic index will have a low Minimum toxicity concentration and a high Minimum effective concentration

The absorption of doxycycline hyclate is not significantly higher in the colon than in the upper small intestine.

A pharmacist who wishes to open a "Compounding Pharmacy" does not need to obtain an additional license from the State Board of Pharmacy before operating such a pharmacy. This means that the statement is false.

Flocculating agents are actually used in drug suspensions to prevent the drug particles from aggregating and forming cakes that are difficult to break apart. These agents help to disperse the drug particles evenly throughout the suspension, allowing for better stability and uniform dosing.

The statement suggests that CONI-Snap capsules have advantages over traditional hard gelatin capsules in dealing with deliquescence-related issues. However, the correct answer is false, indicating that CONI-Snap capsules do not offer significant advantages in overcoming these problems.

Peppermint Water USP is not a clear alcoholic solution saturated with volatile peppermint oil. It is actually a clear, colorless, and odorless liquid that contains purified water and peppermint oil. It is used as a pharmaceutical product for its medicinal properties, such as relieving gastrointestinal discomfort and reducing flatulence. Therefore, the correct answer is False.

Active dry powder inhalers do not rely solely on the inspiratory effort of the patient to generate the energy for powder entrainment and aerosolization. These inhalers typically contain a mechanism, such as a propellant or a device that creates a fine powder dispersion, to aid in the delivery of the medication. Therefore, the correct answer is False.

The answer is Diprivan (propofol) is an intravenous emulsion product because it is the only statement that provides specific information about a product. The other statements either provide general information about a substance (e.g. glycolic acid is a biodegradable polymer) or describe a drug or device without specifying its form or composition (e.g. Lacrisert is a drug delivery device).

Shear thinning materials, such as hydroxypropyl methylcellulose dissolved in water at room temperature, do not exhibit a yield value. Yield value refers to the minimum stress required to initiate flow in a material, and shear thinning materials do not have this property. Instead, they exhibit a decrease in viscosity with increasing shear rate. Therefore, the correct answer is false.

The explanation for the given correct answer is that the statement is false because the Diskhaler does not employ the propellant HFA 134a as the high vapor pressure propellant.

Engeric polymers have not been used to prepare liposomes for targeting drug delivery to the lung. The statement in the question is incorrect.

Oleaginous ointment bases, such as White Petrolatum USP, are hydrophobic and do not contain water. They are made up of oils and fats, which do not readily mix with water. Therefore, they do not absorb water easily. Hence, the given statement is false.

The explanation for the given correct answer, False, is that the statement claims that the Pari LC Plus air-jet nebulizer uses an open vent system that is inefficient at delivering the dose of the drug to the patient with more waste. However, this statement is not supported by any evidence or reasoning. Without any further information, it is not possible to determine the efficiency or wastage of the Pari LC Plus air-jet nebulizer. Therefore, the correct answer cannot be determined based on the given information.

The given answer "none of the above" is correct because the formulation challenges mentioned in the question do not include all the possible challenges associated with poorly water-soluble compounds. While the challenges mentioned in the question are valid, there could be other challenges as well, such as instability, limited stability, or poor physical and chemical compatibility with excipients. Therefore, the correct answer is "none of the above" as it does not encompass all the potential formulation challenges.

The statement is false because recompression or slugging does not involve more compression and drying steps than direct compression in tablet manufacturing. In fact, direct compression involves fewer steps as it eliminates the need for additional compression and drying processes. Recompression or slugging is a technique where the active ingredients are compressed into tablets after being mixed and dried, whereas direct compression involves directly compressing the blend of active ingredients and excipients into tablets without any prior processing steps.

The given statement is false. Aquatcoat does not consist of pseudolatex of an enteric polymer.