Pharmaceutical Manufacturing - Powders & Tablets
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Questions and Answers

What is the primary focus when considering raw materials for percolation?

  • Availability of materials in the market
  • Conformance to specifications (correct)
  • Cost-effectiveness of materials
  • Brand reputation of suppliers
  • Which method is NOT mentioned as a way to sterilize equipment?

  • Ultrasonic cleaning (correct)
  • Dry heat
  • Steam
  • Chemical disinfection
  • What is a critical requirement for water used in the manufacturing process?

  • Must be distilled
  • Must have a high mineral content
  • Needs to be sourced locally
  • Should meet USP requirements (correct)
  • Which of the following is essential for ensuring the cleanliness of mixing tanks?

    <p>Use of appropriate disinfectant dilutions</p> Signup and view all the answers

    Which statement best describes the importance of filtration systems in the manufacturing process?

    <p>They help in achieving and maintaining sterility by removing contaminants.</p> Signup and view all the answers

    Which of the following is classified for oral use?

    <p>Syrup</p> Signup and view all the answers

    What is the main purpose of an acidifying agent in liquid preparations?

    <p>To increase the stability by providing an acidic medium</p> Signup and view all the answers

    Which method is NOT used in the preparation of purified water?

    <p>Evaporation</p> Signup and view all the answers

    Which of the following is NOT a characteristic of solutions?

    <p>Stability with all types of active ingredients</p> Signup and view all the answers

    What role do humectants play in liquid preparations?

    <p>They preserve moisture content</p> Signup and view all the answers

    What is the primary function of a co-solvent in liquid preparations?

    <p>To extract and suspend other materials without chemical change</p> Signup and view all the answers

    Which of the following is an example of an alkalinizing agent?

    <p>Ammonia solution</p> Signup and view all the answers

    Which solvent is known for being used in most liquid preparations?

    <p>Water</p> Signup and view all the answers

    What is the primary purpose of diluents in tablet formulations?

    <p>To increase the bulk content of the dosage form</p> Signup and view all the answers

    Which of the following types of tablets is designed for ease of swallowing?

    <p>Caplets</p> Signup and view all the answers

    What role do binders play in tablet production?

    <p>They glue the tablet ingredients together</p> Signup and view all the answers

    Which of these tablet types is specifically formulated to dissolve slowly over time?

    <p>Sustained release tablets</p> Signup and view all the answers

    What is the primary function of lubricants in tablet manufacturing?

    <p>To reduce friction during compression</p> Signup and view all the answers

    Which of the following ingredients serves to break the tablet apart upon contact with liquid?

    <p>Disintegrants</p> Signup and view all the answers

    What type of tablet is designed for administration beneath the tongue?

    <p>Sublingual tablets</p> Signup and view all the answers

    Which of the following methods is NOT used for large scale preparation of medication?

    <p>Levigation with mortar and pestle</p> Signup and view all the answers

    Which of the following substances can be classified as an organic solvent?

    <p>Isopropyl alcohol</p> Signup and view all the answers

    What is the primary function of an antioxidant agent in pharmaceutical solutions?

    <p>To prevent chemical oxidation</p> Signup and view all the answers

    Which agent is primarily used to optimize the pH of pharmaceutical formulations?

    <p>Buffering agent</p> Signup and view all the answers

    Which of the following is an example of an anti-microbial agent?

    <p>Benzalkonium chloride</p> Signup and view all the answers

    What is the role of a thickening agent in pharmaceutical preparations?

    <p>To prevent sedimentation</p> Signup and view all the answers

    Which substance is widely recognized as a sweetening agent in pharmaceutical products?

    <p>No specific examples provided</p> Signup and view all the answers

    What is the main purpose of a wetting agent in pharmaceutical formulations?

    <p>To reduce interfacial tension</p> Signup and view all the answers

    Which of the following agents would be most effective at discouraging foam formation?

    <p>Ethylhexanol</p> Signup and view all the answers

    What are syrups that contain flavoring agents but no medicinal substances called?

    <p>Nonmedicated syrups</p> Signup and view all the answers

    Which ingredient is NOT typically found in elixirs?

    <p>Sucrose</p> Signup and view all the answers

    What is a primary characteristic that differentiates elixirs from syrups?

    <p>Elixirs are hydroalcoholic liquids.</p> Signup and view all the answers

    Which of the following statements about tinctures is true?

    <p>Tinctures generally require light-resistant containers.</p> Signup and view all the answers

    What can occur if tinctures are mixed with liquids that have diverse solvent characters?

    <p>The solute may precipitate from solution.</p> Signup and view all the answers

    Which component is often added to contribute to the stability of an elixir?

    <p>Preservatives</p> Signup and view all the answers

    What is the opium content in Tincture of Opium compared to Paregoric?

    <p>Tincture of Opium is significantly more potent than Paregoric.</p> Signup and view all the answers

    What characteristic distinguishes medicated syrups from nonmedicated syrups?

    <p>Medicated syrups contain therapeutic agents.</p> Signup and view all the answers

    What is the primary objective of using dry granulation methods?

    <p>To form granules from powders without using moisture</p> Signup and view all the answers

    Which of the following is a method used for dry granulation?

    <p>Slugging</p> Signup and view all the answers

    What is the role of the Ribbon Mixer Machine in granulation?

    <p>To efficiently blend dry powders and granules</p> Signup and view all the answers

    What happens during the 'screening of slugs' step in the dry granulation process?

    <p>Large tablets are broken down into smaller granules</p> Signup and view all the answers

    Which machine is specifically used to improve the compression characteristics of the mixture?

    <p>Rapid Mixer Granulator</p> Signup and view all the answers

    What characteristic makes the Fluid Bed Dryer Machine essential in the granulation process?

    <p>It controls the moisture content in tablet formulations</p> Signup and view all the answers

    How do Sigma type blades function in mixing powders?

    <p>They rotate in the same direction along a horizontal axis</p> Signup and view all the answers

    What is the purpose of using a V-Blender Machine?

    <p>To homogenously blend dry powders and granules</p> Signup and view all the answers

    Study Notes

    Pharmaceutical Manufacturing - Powders

    • Powders are solid or mixtures of solids, reduced to a finely divided state.
    • Used internally (oral, nasal, insufflation) and externally (topical).
    • Advantages: flexibility in compounding, dose adjustment, good chemical stability.
    • Disadvantages: time-consuming to prepare, potential for dosage inaccuracy, unpleasant taste.
    • Types include: topical, insufflated, medicated, bulk, divided.
    • Bulk powders are often mixed with other materials before administration (e.g., powder for suspension).
    • Small scale powder preparation methods: trituration/comminution, pulverization, levigation.
    • Large scale preparation methods: Fitzmill comminutor, tumbling, mixing/mixer, V-blender.

    Pharmaceutical Manufacturing - Tablets

    • Tablets are circular or disk-shaped, can resemble capsules (caplets).
    • Designed to be easier to swallow.
    • Types: compressed, sugar-coated, film-coated, enteric-coated, effervescent, chewable, dispersible, sustained-release, multiple, sublingual, buccal.
    • Excipients include: diluents (increase bulk), binders (glue ingredients), disintegrants (dissolve in water), lubricants (reduce friction).

    Pharmaceutical Manufacturing - Granulation

    • Wet granulation is the most common agglomeration process in the pharmaceutical industry.
    • Powder blend is mixed with a granulating liquid.
    • Important steps: weighing/blending, preparing dampened powder/mass, screening dampened powder/mass, drying the granulation, sizing the granulation.
    • Dry granulation: powder mixture is compressed without heat or solvents, least desirable method.
    • Two methods: slugging (repressing), milling.

    Pharmaceutical Manufacturing - Granulators & Mixers

    • Rapid Mixer Granulator: prevents segregation of ingredients, improves compression characteristics.
    • Fluid Bed Dryer Machine: granulation process for drying, correct moisture content.
    • Ribbon Mixer Machine: efficient and versatile for mixing dry granules and powders.
    • Double Cone Blender: sigma type blades rotate in the same direction.

    Pharmaceutical Manufacturing - Capsules

    • Capsules can be tasteless, odorless, easy to administer, and visually appealing.
    • Hard shell capsules: typically made of gelatin containing dry, powdered ingredients or miniature pellets.
    • Soft shell capsules: primarily for oils or ingredients dissolved/suspended in oils.
    • Ingredients include: gelatin, water, preservatives, colors, opacifiers, flavoring agents, sugars, acids, plasticizers.

    Pharmaceutical Manufacturing - Solutions

    • Solutions are liquid preparations with one or more chemical substances dissolved in a solvent.
    • Types include: aqueous (water-based) and non-aqueous (other solvents).
    • Classified by use for: oral, otic, ophthalmic, topical.
    • Classified by composition/use: syrups, elixirs, spirits, tinctures, injections.
    • Solvents: alcohols, glycerin, propylene glycol, water.
    • Ingredients used to increase stability or solubility: antioxidants, buffering agents, antimicrobials.

    Pharmaceutical Manufacturing - Manufacturing Considerations

    • Raw Materials: must conform to specifications (identity, potency, free from contaminants).
    • Water: extremely important, and must meet specific USP requirements (e.g., sterilization, quality control).
    • Processes: carefully consider techniques like sterilization, filtration, preventing contamination.

    Pharmaceutical Manufacturing - Filling & Packaging

    • Automatic machines: used for filling and sealing bottles, vials, ampoules with appropriate quality control and safety checks.
    • Volumetric filling: delivers premeasured volume to each container.
    • Timed flow filling: determines the fill volume by controlling the time.
    • Gravimetric filling: filling method for viscous products, ensuring consistent volume in each container.
    • Vacuum filling: uses vacuum to control the flow.

    Pharmaceutical Manufacturing - Blister Packing

    • Blister packing machines: automatic machines for packing small and regular shaped products like tablets, capsules.
    • Processes involved: blister forming, product feeding, sealing.

    Pharmaceutical Manufacturing - Other Equipment

    • Rotary Die Machine: for encapsulating flows by gravity; the process is for the gelatin sheets feeding to the die pocket of the die roll, then being continuously filled with liquid or paste and the sealed capsule cut by the mechanical.
    • Rotary Tablet Press Machines: presses powder to form tablets.
    • Capsule Filling Machine: fills the capsule shell with the desired substance efficiently.
    • High-Speed Automatic Bottle Filling & Cap Sealing Machines: for filling and capping bottles, with various filling capacities per minute.
    • Rotary Bottle Washing Machine: for cleaning and washing.
    • Bottle Unscramblers/Labelling Machines/Carton Machines: for final packaging processing stages, like unscrambling bottles, labeling, and cartonization.

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    Description

    Explore the fundamental aspects of pharmaceutical manufacturing regarding powders and tablets. This quiz covers the advantages and disadvantages of powders, their preparation methods, and the various types of tablets available. Test your knowledge on these critical components of drug formulation.

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