Exam 1 - Phintern 2

The correct answer is "Quarantined." In this scenario, the raw materials are being held in quarantine because they need to undergo tests and assays by the QC department. Quarantining the materials ensures that they are not used or mixed with other materials until they have been tested and approved. This helps to prevent any potential contamination or quality issues from affecting the production process.

Compressibility refers to the ability of a material to be compressed and form a stable, compact mass when pressure is applied. In the context of tablet formulations, it is important for the material to have good compressibility as it ensures that the tablets maintain their shape and integrity during manufacturing processes such as compression. A material with high compressibility will result in tablets that are easy to handle, have uniform weight and thickness, and disintegrate properly when consumed. Therefore, compressibility is an ideal property for tablet formulations to ensure the production of high-quality tablets.

Spray-drying is the correct answer because it involves the process of producing finely divided particles by spraying a mist of liquid through a heated chamber. The liquid quickly dries in the hot air, leaving behind dried powders that are collected in a clean receptacle. This method is commonly used in various industries to create powdered products such as food ingredients, pharmaceuticals, and chemicals.

Intravenous administration is the correct answer because it involves injecting a solution directly into the veins. This route allows for immediate absorption of the medication into the bloodstream, bypassing the need for absorption through the gastrointestinal tract or other tissues. Intravenous administration is preferred when an instantaneous pharmacological effect is desired, as it allows for rapid and efficient delivery of the medication to the target site.

Oily liniments are milder than alcohol-based liniments.

Titanium dioxide is used as an opaquant in tablet coating. Opaquants are substances that provide opacity or whiteness to the coating, making it more visually appealing and masking the color of the tablet's core. Titanium dioxide is commonly used in pharmaceutical tablet coatings to achieve a solid, opaque, and uniform appearance. It helps to ensure that the tablet's color and any imperfections in the core are not visible, enhancing the overall aesthetic appeal of the tablet.

Mottling is a tablet production problem that refers to a defect where the color distribution is not uniform throughout the tablet. This means that there are variations in color intensity or patches of different colors on the surface of the tablet. This defect can occur due to issues with the mixing or distribution of the colorants during the tablet manufacturing process.

Hygroscopicity refers to the ability of a substance to absorb moisture from the surrounding environment. In the context of tablet fillers, a hygroscopic filler would absorb moisture from the formulation, leading to changes in the tablet's physical properties and potentially affecting its stability. Therefore, being hygroscopic is not an ideal property for tablet fillers as it can compromise the quality and performance of the tablets.

Generic name should have the highest point size, written in the same font as the brand name.

The correct answer is the Limulus method. This method is an in-vitro method of pyrogen testing that uses lysate from amoebocytes of the horseshoe crab. The lysate reacts with pyrogens, causing a color development that can be measured. The other options, qualitative fever response in rabbits and qualitative fever response in mice, are not in-vitro methods and do not involve the use of horseshoe crab lysate.

Content uniformity refers to the consistency of the distribution of active ingredients in a batch of finished tablets. It ensures that each tablet contains the same amount of active ingredient, allowing for consistent and accurate dosing. This parameter is important to ensure the effectiveness and safety of the medication, as variations in content can lead to inconsistent therapeutic effects or potential overdosing. Therefore, content uniformity is the correct answer for this question.

A torque tester is used to check the tightness of cap closures. It measures the amount of rotational force required to open or close a cap. By using a torque tester, manufacturers can ensure that caps are tightened to the correct level, preventing leaks or contamination. This is especially important in industries such as pharmaceuticals or food and beverage, where product integrity is crucial. The other apparatus listed (Crimper, pH meter, and Digital caliper) are not specifically designed for checking the tightness of cap closures.

Chewable tablets do not need to conform to USP disintegration time because they are designed to be chewed and dissolved in the mouth before swallowing. The disintegration time is not relevant for these tablets as they are intended to be broken down and absorbed in the oral cavity rather than in the stomach or intestines like other solid dosage forms.

Simple Syrup USP is fully self-preserving.

The correct answer is I, II, and III.

Gelatin is indeed obtained through the partial hydrolysis of collagen, which is derived from the skin, white connective tissue, and bones of animals. Gelatin is insoluble in cold water but can soften and absorb up to ten times its weight in water. It is also soluble in hot water and warm gastric fluid, which allows for rapid dissolution of gelatin capsules and exposure of their contents. Therefore, all three statements are true.

The primary display panel of medicinal preparations should include important information such as the pharmacologic category, name of the manufacturer, and whether it is for external use only. However, the formulation of the preparation does not need to be mentioned on the primary display panel. The formulation refers to the specific ingredients and composition of the medication, which is typically provided in the package insert or on the product label itself, but not on the primary display panel.

Pyrogens are substances that can cause fever when introduced into the body. In the manufacture of parenterals (products that are injected into the body), potential sources of pyrogens can include contaminated water and solutes, contaminated equipment, and even the manufacturing methods themselves. All three options (I, II, and III) are potential sources of pyrogens and can contribute to the presence of these fever-inducing substances in parenteral products.

I. Emulsions are thermodynamically unstable systems, and oil is the dispersed phase in O/W emulsions.

Lamination is the tablet processing problem that appears as the separation of the tablet into several distinct horizontal layers. This occurs when the tablet formulation does not bind properly, causing the layers to separate.

Multiple-layered compression is the best method to use for tablet formation when the tablet formulation contains two APIs that are chemically incompatible with each other. This method involves compressing multiple layers of different materials, allowing for the physical separation of the incompatible APIs. This prevents direct contact between the APIs, reducing the chances of chemical reactions or degradation. Dry granulation, wet granulation, and slugging methods may not provide the same level of physical separation and may lead to chemical interactions between the APIs.

The correct order of tablet sugarcoating is sealing, subcoating, smoothing, color coating, and polishing. The process begins with sealing the tablet to prevent moisture and other substances from entering. Then, a subcoating is applied to create a smooth surface for the color coating. After that, the tablet is smoothed to remove any imperfections. Next, a color coating is added to give the tablet its desired appearance. Finally, the tablet is polished to enhance its shine and overall aesthetic appeal.

Most commonly used fixed oils for injections: Mnemonic, CoCoPeSe

1. Cottonseed oil
2. Corn oil
3. Peanut oil
4. Sesame oil

UV radiation method is a non-thermal form of sterilization that uses mercury vapor lamps to reduce airborne microbes. UV radiation damages the DNA of microorganisms, preventing them from reproducing and causing infections. This method is commonly used in hospitals, laboratories, and other environments where a high level of cleanliness is required. It is effective against a wide range of pathogens and does not leave any residue or chemical by-products, making it a safe and environmentally friendly sterilization option.

Aspartame is the correct answer because it is a sweetening agent that is 200 times sweeter than sucrose (table sugar), has no aftertaste, and provides approximately 4 kcal per 1 g. Saccharin and cyclamate are also artificial sweeteners, but they do not meet all the given criteria. Sucralose is another artificial sweetener, but it is not 200 times sweeter than sucrose. Therefore, aspartame is the best fit for the given description.

Magnesium stearate is an antiadherent / lubricant.

The dissolution of a prednisone tablet in the body can be affected by several manufacturing variables. The amount and type of binder added can influence the rate at which the tablet disintegrates and releases the drug. Similarly, the amount and type of disintegrant added can also affect the tablet's ability to break down. Additionally, the force of compression used during tableting can impact the tablet's overall structure and disintegration properties. Therefore, all three variables (I, II, and III) are likely to affect the dissolution of a prednisone tablet in the body.

The ethanol content in tinctures & elixirs and the high concentration of sugar in syrup prevent microbial growth. Aqueous solutions are most susceptible to microbial growth, thus shortening shelf life.

Multi-directional movement between rooms increases the risk of cross-contamination and mix-ups.

A dilatant or shear-thickening substance is a Non-Newtonian fluid where the shear viscosity increases with applied shear stress.

Powders are intimate mixtures of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. Powders are commonly used in pharmaceuticals, cosmetics, and other industries for their ease of administration and versatility. They can be dissolved in liquids, applied topically, or taken orally. Powders are preferred for their ability to be accurately measured and their rapid dissolution or dispersion in the body. They can be formulated to have specific properties such as controlled release or improved bioavailability. Overall, powders are a widely used form of medication or substance delivery.

Multiple-dose parenterals have an increased risk for microbial contamination due to exposure of remaining product to the environment each time a dose is administered.

Sticking - adhesion of tablet particles to the die wall
Picking - adhesion of tablet particles to the punch

Most biological products are stored at temperatures between 2 - 8 °C. This temperature range is commonly used for storing vaccines, blood products, and other sensitive biological materials. It helps to maintain the stability and integrity of these products, preventing spoilage or degradation. The range of 2 - 8 °C is considered ideal for preserving the potency and efficacy of biological products, ensuring that they remain safe and effective for use.

Picking refers to the phenomenon where the granules in a tablet formulation stick to the surface of the tablet press and are pulled away during ejection, resulting in a rough or pitted appearance on the tablet surface. This issue is often caused by excessive moisture in the granulation. When the granulation is too wet, it can lead to poor binding and cohesion of the particles, causing them to stick to the tablet press surfaces instead of forming a solid tablet. Therefore, excessive moisture in the granulation is a likely explanation for picking in tablet manufacturing.

Leaching refers to the process of components moving from the packaging material into the contents it holds. This phenomenon can occur when there is a chemical interaction between the packaging material and the contents, causing the components to dissolve or be released into the product. Leaching can lead to contamination of the contents and potentially affect their quality or safety.

Manufacturing overage refers to the incorporation of excess materials in a pharmaceutical preparation to compensate for expected loss during manufacture. This allows for any potential loss or variation in the manufacturing process, ensuring that the final product meets the required specifications and quantities. By adding extra materials, the manufacturer can account for any potential losses and maintain the desired quantity and quality of the pharmaceutical preparation.

General Inspection Level I - Less stringent inspection level for trusted companies which consistently deliver quality materials
General Inspection Level II - Default inspection level
General Inspection Level III - Rigorous inspection level for companies which have delivered substandard materials

Film coating is the correct answer because it imparts the same general characteristics as sugar coating, such as improving the appearance, taste, and odor of the coated material. Additionally, film coating has the added advantage of reducing the time required for the coating operation compared to sugar coating. This makes film coating a more efficient and time-saving option.

Flocculating agents cause the solid particles to aggregate, which encourages settling of particles in suspension.

Parabens are a type of preservative commonly used in cosmetic and personal care products. They are considered broad-spectrum, meaning they are effective against a wide range of microorganisms, including bacteria and molds. Parabens work by inhibiting the growth and reproduction of these microorganisms, helping to extend the shelf life of products and prevent spoilage. However, it is important to note that there has been some controversy surrounding the safety of parabens, as studies have suggested a possible link to hormone disruption.

Silica-containing materials are used as lubricants in pharmaceutical formulations. Lubricants are substances that are added to improve the flowability of the powders during the manufacturing process. They reduce friction between particles and equipment surfaces, preventing sticking or clumping. Silica-containing materials have excellent lubricating properties and are commonly used in tablet and capsule formulations. They help in the smooth and efficient production of pharmaceutical products by ensuring uniform mixing and easy tablet compression.

Imbibition refers to the process in which a gel absorbs liquid without any significant change in its volume. This phenomenon occurs due to the capillary action, where the liquid is drawn into the gel's network of pores or spaces between its particles. As a result, the gel swells and takes up the liquid, but the overall volume remains relatively unchanged. This process is commonly observed in various natural and synthetic gels, such as hydrogels, where they can absorb large amounts of water without expanding significantly.

Heat-labile and volatile substances are added later, after the preparation has cooled, to avoid thermolysis or evaporation of substances.

Cornstarch can be used as a tablet diluent, disintegrant, and binder. As a diluent, it helps to increase the bulk of the tablet and facilitate the manufacturing process. As a disintegrant, it promotes the breakup of the tablet in the gastrointestinal tract, allowing for better absorption of the active ingredients. And as a binder, it helps to hold the tablet together and ensure its structural integrity. Avicel, lactose, and celutab may also be used as tablet diluents, but they do not serve as both disintegrants and binders.

Magnesium stearate is a lubricant, which prevents sticking of powder particles on processing equipment. Gelatin acts as a binder. Talc is a glidant. Sodium starch glycolate is a disintegrant.

As an excipient, lactose functions as a diluent or filler. Talc, starches, and silicious materials are all glidants. Starch, in particular, is a popular choice as it has the additional value of disintegrant.

Tinctures are alcoholic or hydroalcoholic solutions prepared from vegetable materials or chemical substances. This means that they are made by dissolving these substances in alcohol or a mixture of alcohol and water. Tinctures are commonly used in herbal medicine and homeopathy as a way to extract and preserve the active compounds from plants or other substances. They are often taken orally and are known for their concentrated and potent effects.