Pharmaceutical Manufacturing Overview
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Questions and Answers

What is the purpose of a Disintegrant in a tablet?

  • To facilitate the breakup of a tablet in contact with an aqueous medium (correct)
  • To provide a pleasant taste to the drug
  • To help the tablet maintain its shape during compression
  • To reduce friction between the tablet and die wall during ejection

    • What does HLOA stand for?

    Heat Labile Organic Active

    What type of container provides protection from both photochemical degradation and moisture?

    Light-resistant Amber bottle

    Direct compression tablet processing is often preferred for crystalline substances due to their improved flowability and compressibility.

    <p>True (A)</p> Signup and view all the answers

    What is the primary function of a plasticizer in a film coating?

    <p>To increase the flexibility and elasticity of the coating film (B)</p> Signup and view all the answers

    In a clean room classified as Class 100, the maximum number of particles greater than 0.5 µm allowed per cubic foot is ______.

    <p>100</p> Signup and view all the answers

    The tip-seal method of ampoule sealing is considered a more robust and reliable method compared to the pull-seal method.

    <p>False (B)</p> Signup and view all the answers

    Which of the following is NOT a typical function or characteristic of a flocculating agent in liquid suspensions?

    <p>Promote the adherence of particles to the container walls (B)</p> Signup and view all the answers

    What is the purpose of a sterile production area?

    <p>To manufacture sterile dosage forms in a controlled environment with minimal risk of contamination.</p> Signup and view all the answers

    What is the purpose of a HEPA filter in a sterile production area?

    <p>To remove airborne particles, like dust and bacteria, from the air.</p> Signup and view all the answers

    Which sterilization method is most commonly used for heat-labile materials?

    <p>Filtration (D)</p> Signup and view all the answers

    In a gravity filling process, the filling operation is hand-operated.

    <p>True (A)</p> Signup and view all the answers

    Which of the following is NOT a common method used to preserve or stabilize liquid dosage forms?

    <p>Preservation by using anesthetics (B)</p> Signup and view all the answers

    The principle of simple solution involves dissolving the solute in a solvent and adjusting the volume to a desired concentration.

    <p>True (A)</p> Signup and view all the answers

    What is the main advantage of using solution by extraction as a preparative method for certain drug products?

    <p>It allows for the extraction of active ingredients from natural sources, like plants or animals.</p> Signup and view all the answers

    Filtration is often used to remove impurities from liquids during solution preparation.

    <p>True (A)</p> Signup and view all the answers

    Which of the following is NOT a common characteristic of a HMW alcohol used as an emulsifying agent?

    <p>Water-soluble (A)</p> Signup and view all the answers

    What is the main reason for using surfactants in pharmaceutical formulations?

    <p>Surfactants help to reduce surface tension and enhance the dispersion of ingredients in liquid or semi-solid formulations.</p> Signup and view all the answers

    The phase inversion of an emulsion refers to the irreversible conversion from an o/w emulsion to a w/o emulsion or vice versa?

    <p>False (B)</p> Signup and view all the answers

    Which of the following is NOT a commonly encountered problem during the tablet compression process?

    <p>Blooming (A)</p> Signup and view all the answers

    What is the primary purpose of sugar coating a tablet?

    <p>To protect the tablet core from moisture, provide a smooth surface, and mask unpleasant taste.</p> Signup and view all the answers

    Which of the following is NOT a typical component of a film coating formulation?

    <p>Antioxidant (D)</p> Signup and view all the answers

    What is the main advantage of using film coating over sugar coating?

    <p>Film coating provides a thinner, more efficient coating that results in less weight gain for the tablet.</p> Signup and view all the answers

    Mottling in coated tablets refers to the uneven distribution of color on the surface, often due to variations in the coating process or the use of multiple colorants.

    <p>True (A)</p> Signup and view all the answers

    What primary advantage does spray drying have over other methods for drying solids?

    <p>Spray drying allows for a more efficient and controlled drying of heat-sensitive materials, preserving their quality and minimizing degradation.</p> Signup and view all the answers

    Which of the following factors is NOT considered crucial for ensuring the stability of a liquid suspension?

    <p>Molecular weight of the suspending agent (C)</p> Signup and view all the answers

    Which of the following sterilization methods is most effective for sterilizing heat-labile solutions?

    <p>Filtration (B)</p> Signup and view all the answers

    An ampule seal that is considered bad is often called a tip-seal due to its vulnerability to contamination during handling.

    <p>True (A)</p> Signup and view all the answers

    In a cleanroom setting, the use of interlocked doors helps to prevent the entry of contaminants from neighboring areas.

    <p>True (A)</p> Signup and view all the answers

    The primary goal of a depyrogenation process is to remove endotoxins and other pyrogens from pharmaceutical products.

    <p>True (A)</p> Signup and view all the answers

    The Class 100 designation for a cleanroom refers to a maximum of 100 particles greater than 0.5 µm per cubic foot.

    <p>False (B)</p> Signup and view all the answers

    The pull-seal method for ampoule sealing involves heating the ampoule neck, pulling the tip, and then sealing the opening with a molten glass bead.

    <p>True (A)</p> Signup and view all the answers

    Overage in pharmaceutical manufacturing refers to the intentional addition of an excess amount of active pharmaceutical ingredient (API) to compensate for potential losses during processing.

    <p>True (A)</p> Signup and view all the answers

    The term Toll Manufacturing refers to an arrangement where a company contracts with another organization to manufacture specific products.

    <p>True (A)</p> Signup and view all the answers

    Which of the following is NOT a standard method used for granulating powders in pharmaceutical manufacturing?

    <p>Micronization (C)</p> Signup and view all the answers

    The secondary packaging of a pharmaceutical product is the outer packaging, which may not always be present for every product.

    <p>True (A)</p> Signup and view all the answers

    A child-resistant container is designed with safety features to prevent young children from accessing and potentially ingesting potentially harmful substances.

    <p>True (A)</p> Signup and view all the answers

    The quality assurance department in a pharmaceutical company is responsible for ensuring that all operations adhere to established standards.

    <p>True (A)</p> Signup and view all the answers

    Flashcards

    Manufacturing Activities

    All stages involved in creating a medication, including primary, secondary, tertiary, and toll manufacturing.

    Primary Manufacturing

    The initial stage, involving raw materials and active pharmaceutical ingredients (APIs).

    Secondary Manufacturing

    Creating the dosage form (e.g., tablets, capsules).

    Tertiary Manufacturing

    Packaging, labeling, and repacking of bulk finished products.

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    Toll Manufacturing

    Manufacturing products for another company based on a contract.

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    Batch

    A specific quantity of drug product manufactured at the same time.

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    Master Batch Record (MBR)

    A detailed document for a batch of drugs, containing all the procedures.

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    Lot

    A portion of a batch from the production process.

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    Quality Assurance

    Ensuring the drug meets safety and efficacy standards (chMP).

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    Overage

    Adding excess API to a preparation to account for loss during processing.

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    Quality Control

    Ensuring product quality and compliance to specifications.

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    Diluents

    Inert substances used to increase tablet size or fill capsules.

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    Disintegrants

    Substances that break up tablets when exposed to water.

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    Lubricants

    Reduces friction during tableting to ease ejection.

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    Glidants

    Reduces friction amongst particles to improve flow.

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    Colorants

    Substances to improve appearance by disguising off-color drugs.

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    Flavorants

    Substances to mask undesirable tastes of medications.

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    Sweeteners

    Substances that mask unpleasant tastes of medications.

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    Wet Granulation

    A common method of granulation involving adding liquid binders to powders to form agglomerates.

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    Dry Granulation

    Compacting powders into larger pieces and then crushing them into granules.

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    Tableting

    Compressing materials into solid dosage forms like tablets.

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    Direct Compression

    Tablet manufacturing without granulation.

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    Coating

    Applying a layer on tablets to improve appearance, taste, and stability.

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    Sugar Coating

    Adding layers of sucrose-based solutions to tablets.

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    Film Coating

    Applying a thin polymer film to tablets.

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    Hard Gelatin Capsules (HGC)

    Capsules made of gelatin shells used to contain medications.

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    Study Notes

    Manufacturing Activities

    • Production involves all stages of drug product manufacturing
    • Batch manufacturing records (BMRs) or master batch records (MBRs) document the process
    • A batch is a specific quantity of drug product with uniform character and quality
    • A lot is a portion of a batch
    • Batch/lot numbers provide identification and traceability
    • Warehouses store materials and finished products
    • Incoming components are held in a quarantine area (yellow label)
    • Purchasing and logistics are warehouse activities

    Departments in a Manufacturing Company

    • Research and development: formulates new products, improves existing products, and prepares the master formula (with overages)
    • Overage: addition of excess API, in an unstable preparation

    Quality Control

    • Tests for compliance with material specifications
    • Conducts sampling and testing
    • Performs in-process quality control and environmental testing

    Marketing

    • Studies current trends, consumer behavior, and product status
    • Advertisement and promotion activities

    Regulatory

    • Ensures compliance with pertinent laws and regulations
    • Licensing to operate (LTO) and certificate of product registration (CPR) are required

    Engineering

    • Installs, maintains, and repairs equipment
    • Conducts validation and qualification

    Solid Dosage Forms

    • Formulator Components
      • Diluents (fillers/bulking agents): inert substances increasing tablet size/filling capsule body
      • Other components:
        • Lactose: most common, anhydrous/spray dried
        • Sucrose and Dextrose: microcrystalline cellulose, starch
        • Multifunctional: Dibasic Calcium Phosphate, mannitol, xylitol
        • Starch paste, acacia, tragacanth, gelatin
        • Cellulose derivatives: methylcellulose, ethylcellulose, carboxymethylcellulose, hydroxypropylmethylcellulose
        • Disintegrants: facilitate tablet breakup in an aqueous medium ("double disintegration")
          • Examples: sodium starch glycolate (Primojel/Explotab), crospovidone, croscarmellose Na
        • Anti-frictional agents: reduce friction and improve flow.
          • Example: hydrophobic agents added at low concentrations prior to compression
        • Lubricants: reduce friction
        • Glidants: reduce friction between particles to enhance flow
        • Antiadherents: prevent sticking
        • Colorants: dyes to disguise off-color drugs and improve appearance.
        • Examples: synthetic organic colorants, lakes (dyes adsorbed on an inorganic oxide; iron oxide, aluminum oxide)
        • Stearates (Mg, Ca, Na): lubricant, anti-adherent, glidant, and stearic acid
        • Purified Talc: anti-adherent, lubricant
        • Colloidal Talc, Colloidal SiO2 (cab-o-sil), silicates (Ca,Mg): glidants
    • PEG & Lauryl Sulfate & Sodium Hydrophillic Lubricants

    Flavorants

    • Masks unpleasant tastes of drugs
    • Examples: Salty (cinnamon, orange, cherry, butterscotch), Bitter (chocolate, cherry, raspberry), Sour (fruity), Oily (mint, orange, lemon), Unpleasantly sweet (vanilla and fruity)

    Blending, Overshadowing, and Physical Properties

    • Blending: combines fruit flavors with sour tastes, and bitter, salty, sweet, sour tastes to reduce sourness and increase sweetness
    • Overshadowing: uses flavors whose intensities are stronger than the obvious flavor
    • Physical Properties: formation of insoluble compounds, emulsification of oils, effervescence, high viscosity of fluids, coating of tablets.
    • Chemical properties: adsorption of the drug on a substance, and formation of a complex of the drug

    Unit Processes (Tablets)

    • Dispensing: weighing and measuring materials
    • Milling: particle size reduction, (e.g. crushing, grinding)
    • Mixing: blending materials, achieving uniform mixing and removing color distribution issues (avoiding segregation)
    • Batch Type Mixer: All materials are loaded together, mixed for a long period, and discharged in a single batch.
    • Continuous Mixer: material continuously travels and moves through the equipment, mixing while traveling.
    • Granulation: involves powder size enlargement into granules
    • Dry Granulation: utilizes double compression to form large tablets, which are then crushed
    • Tableting: compression of materials within the die cavity by the pressure exerted by the punches

    Coating

    • Double Impression: Due to free rotation of the punches
    • Mottling: uneven color distribution
    • Sweating: oily film due to humidity conditions
    • Bridging: markings are obscured due to the coating pulling away within the logo
    • Logo-infilling: due to coating accumulated in the logo areas
    • Chipping: due to excessive moisture, causing adhesion of the material to the press punch, or lack of binder
    • Crackling, sticking: due to excipients and expansion of the tablets
    • Film Cracking: Due to thermal expansion of tablet cores during over-drying, or excessive moisture uptake
    • Delayed Dissolution: exposure to coating process conditions

    Capsules

    • Hard Gelatin Capsules (HGC): manufacture in separate operation (filling)
    • Soft Gelatin Capsules (SGS): formed, filled, and sealed in a single operation.

    Semisolid Dosage Forms

    • Ointments: incorporation of components, mix until uniform, may include fusion
    • Gels: substances with high viscosity increase is added
    • Other: homogenizers, ultrasonifiers, and chemicals (acids, esters, etc.)

    Stability Enhancers

    • Preservatives: prevent microbial growth
    • Antioxidants: prevent oxidation of ingredients (APIs, fats, and oils)

    Packaging and Storage

    • Packaging for protection from pollutants and environment.
    • Types: Primary Packaging (direct contact with the product) and Secondary Packaging (outer packaging)
    • Classification: Well-closed, tight, hermetic, light-resistant, child-resistant, tamper-resistant
    • Types of Containers -Bottles, Caps, Liners, Fillers, etc

    Sterilization Methods

    • Moist Heat: autoclaving (121 degrees, 15 psi, 15-20 minutes)
    • Dry Heat: oven sterilization (160°C - 170°C, 2-4 hours)
    • Filtration: using Membrane filters, 0.23 µm filters
    • Gas: using ethylene oxide, formaldehyde, B-propiolactone
    • Ionizing radiation: using Gamma or cathode rays

    Clean Rooms

    • Classification based on particle concentration (e.g., ISO Class 100, 1000, 10,000)
    • Cleanroom procedures for handling, storage, and preparation of sterile products.
    • Procedures for cleaning and sterilization of equipment in the preparation areas.

    Types of Polymers

    • Polyethylene, terephthalate, high-density polyethylene, polyvinyl chloride, low-density polyethylene, polypropylene
    • Metal, Foil, Films and laminates, Rubber, Paper.

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    Manufacturing Activities PDF

    Description

    Explore key concepts in pharmaceutical manufacturing, including production processes, batch and lot identification, and quality control measures. This quiz covers departmental roles, from research and development to marketing strategies. Test your understanding of the entire manufacturing lifecycle of drug products.

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