Design of Medicines Manufacturing Considerations 25
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Questions and Answers

What is the main focus of the MPharm Design of Medicines?

  • Why design of medicines is important (correct)
  • Small scale manufacture
  • Examples of pharmaceutical formulations
  • The method of manufacturing drugs

    • What does formulation in pharmaceuticals involve?

  • Ensuring biological and physical performance of the drug (correct)
  • Conversion of medicine into drugs
  • Manufacturing ingredients
  • Small scale vs large scale manufacturing

    • Why are small scale products (extemporaneous dispensing or compounding) used?

  • They have a longer shelf life
  • They are more cost-effective
  • They are used when medicinal products are not available (correct)
  • They are better controlled

    • What is the purpose of formulating a drug?

    <p>To achieve bioavailability, stability, and efficacy</p> Signup and view all the answers

    When are extemporaneous preparations used?

    <p>When a specific patient requests it</p> Signup and view all the answers

    What does pharmaceutical formulations involve?

    <p>Method of manufacture, ingredients, excipients, appearance, colour, and taste</p> Signup and view all the answers

    What is the recommended method for dispensing divided powders (Chartula)?

    <p>Dispensing in small cellophane or polyethylene envelops</p> Signup and view all the answers

    How should the zinc, starch, and talc dusting powder BPC be stored?

    <p>In a cool and dry place</p> Signup and view all the answers

    What should the labels for the zinc, starch, and talc dusting powder BPC indicate?

    <p>For external use only</p> Signup and view all the answers

    What is the advised application method for the zinc, starch, and talc dusting powder BPC?

    <p>Lightly dust onto the affected area</p> Signup and view all the answers

    What is used as an inert diluent for the trituration of digoxin in the example of powders to be taken orally?

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

    What balance class is recommended to be used for the example of powders to be taken orally?

    <p>Balance class B (100mg)</p> Signup and view all the answers

    What type of dilution will be produced for the example of powders to be taken orally?

    <p>1 in 10 dilution</p> Signup and view all the answers

    Which method will be applied for mixing powders in the example of powders to be taken orally?

    <p>Geometric method</p> Signup and view all the answers

    What is the recommended shelf-life for the example of powders to be taken orally?

    <p>2-4 weeks</p> Signup and view all the answers

    How should the storage of hygroscopic powders be managed?

    <p>Storage should be moisture proof and airtight</p> Signup and view all the answers

    Which of the following is a key consideration for manufacturing medicines in glass or plastic containers?

    <p>Containers must not interact with the product and cause a change in quality.</p> Signup and view all the answers

    What information must appear on the label of a dispensed medicine?

    <p>The quantity and instructions for the patient</p> Signup and view all the answers

    What is a requirement for the storage of the 15% Chalk mixture?

    <p>The expiry date must not exceed 2 weeks.</p> Signup and view all the answers

    What is the dilution factor used to prepare 200mL of peppermint water?

    <p>1+39</p> Signup and view all the answers

    What is a disadvantage of using powders as a dosage form?

    <p>They are problematic in masking unpleasant tastes.</p> Signup and view all the answers

    What method is used to reduce particle size by grinding with a mortar and pestle?

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

    What kind of powders should be handled with care and double wrapping is recommended for protection?

    <p>'Hygroscopic and deliquescent powders'</p> Signup and view all the answers

    Which of the following is NOT a requirement for labeling additional information on a dispensed medicine?

    <p>The color of the medicine</p> Signup and view all the answers

    What is an advantage of using powders as a dosage form?

    <p>They are more stable than liquid formulations.</p> Signup and view all the answers

    What is a key consideration for manufacturing medicines in glass or plastic containers?

    <p>Caps should be closed tightly to avoid premature degradation.</p> Signup and view all the answers

    What is required to prepare 100 mL of 15% Chalk mixture?

    <p>Chalk 15g, Powdered tragacanth 0.2g, Concentrated Cinnamon Water 2.5mL, Double strength chloroform water 50mL, Water to 100mL</p> Signup and view all the answers

    What is the main focus of the MPharm Design of Medicines?

    <p>Preparing powders as a dosage form</p> Signup and view all the answers

    What is one of the unique roles of pharmacists and formulation scientists?

    <p>They have knowledge of physical, chemical, and biopharmaceutics</p> Signup and view all the answers

    What does the Medicines Act 1968 control?

    <p>Manufacture, Distribution, and Introduction of medicinal products</p> Signup and view all the answers

    What are the factors that affect the safety of medicines?

    <p>Correct drug, correct dose, correct method of delivery</p> Signup and view all the answers

    What is important for the quality of medicines?

    <p>Operation of a Quality Assurance (QA) program</p> Signup and view all the answers

    What is dependent on various factors when formulating a drug?

    <p>How a drug is formulated</p> Signup and view all the answers

    What are some examples of dosage forms?

    <p>Suspensions, solutions, tablets</p> Signup and view all the answers

    What is the shelf life of extemporaneous preparations (small scale manufacture)?

    <p>Does not exceed one month</p> Signup and view all the answers

    What are suspensions?

    <p>Preparations containing fine drug particles distributed uniformly throughout a vehicle</p> Signup and view all the answers

    What is important in the preparation of suspensions to prevent clumping and uneven suspension?

    <p>Familiarity with properties of the dispersed phase and dispersed medium</p> Signup and view all the answers

    What are shelf-life expiration dates calculated from?

    <p>Shelf-life at the time of preparation</p> Signup and view all the answers

    Pharmaceutical formulations involve the design of dosage forms to ensure the biological and physical performance of the drug are met.

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

    Small scale products, such as extemporaneous dispensing or compounding, are always well-controlled.

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

    The formulation of a drug includes only the method of manufacture and the ingredients used.

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

    Most medicines are manufactured under uncontrolled conditions.

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

    Extemporaneous preparations are medicines prepared without a legal prescription from a prescriber for a specific patient.

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

    The purpose of formulating a drug is to achieve bioavailability, stability, and efficacy.

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

    Divided powders (Chartula) are typically dispensed in cellophane or polyethylene envelops.

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

    Zinc, starch, and talc dusting powder BPC should not be applied to broken skin or large raw areas.

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

    Lactose is used as an inert diluent for the trituration of digoxin in the example of powders to be taken orally.

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

    The geometric method will be applied for mixing powders in the example of powders to be taken orally.

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

    The shelf-life of powders to be taken orally is typically 2-4 months.

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

    Hygroscopic powders should be stored in a cool and dry place.

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

    Small scale products are used for centralized manufacturing.

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

    The storage of the 15% Chalk mixture requires protection from light.

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

    The Medicines Act 1968 does not control the dispensing of medicines.

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

    Powders and granules are discussed in the book 'Pharmaceutical Practice, 4th Edition' authored by Winfield, A.J., Rees, J.A., and Smith, I.

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

    Glass or plastic containers must be clean before they are filled.

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

    Chalk mixture should be stored in a clear bottle.

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

    The label of a dispensed medicine must include the patient's age.

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

    Powders are more stable than liquid formulations.

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

    Powders and granules have slower dissolution rates than tablets or capsules.

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

    Mortar and pestle are used for levigation in powder preparation.

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

    Effervescent powders are suitable for drugs that are inactivated in the stomach.

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

    Powders may be dispensed to a patient and used in a bulk form only.

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

    The dilution factor 1+39 is used to prepare concentrated peppermint water.

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

    Chalk mixture should be stored in a clear bottle.

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

    Magnesium Trisilicate Mixture should be stored in a clear bottle.

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

    Peppermint water is available as concentrated peppermint water only.

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

    Pharmacists have knowledge of physical, chemical, and biopharmaceutics.

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

    Medicines have only one function: to prevent and cure diseases.

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

    The Medicines Act 1968 controls the distribution and introduction of medicinal products.

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

    The safety of medicines is affected by the correct drug, correct dose, and correct label.

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

    All pharmaceutical manufactures must follow Standard Operation Procedures (SOPs) for producing medicines.

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

    The same drug will always be presented in the same dosage form.

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

    Shelf-lives for extemporaneous preparations (small scale manufacture) do not exceed one month.

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

    Suspensions are preparations that contain large drug particles distributed uniformly throughout a vehicle.

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

    Adding a flocculating agent creates a deflocculated suspension.

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

    Powders in liquid form decompose faster than those in solid forms.

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

    Adding a preservative to a pharmaceutical product is not necessary to protect against bacterial contamination.

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

    Extemporaneous compounding of suspensions involves adding the required prescribed drug into a mortar or crushing tablets containing the drug using a mortar with a pestle.

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

    What is the purpose of formulating a drug in pharmaceuticals?

    <p>To achieve bioavailability, stability, and efficacy.</p> Signup and view all the answers

    When are extemporaneous preparations used?

    <p>When medicinal products are not available.</p> Signup and view all the answers

    What are the factors that affect the safety of medicines?

    <p>Correct drug, correct dose, and correct label.</p> Signup and view all the answers

    What are some examples of dosage forms?

    <p>Tablets, capsules, powders, suspensions, emulsions, and ointments.</p> Signup and view all the answers

    What method is used to reduce particle size by grinding with a mortar and pestle?

    <p>Levigation.</p> Signup and view all the answers

    What is important in the preparation of suspensions to prevent clumping and uneven suspension?

    <p>Proper mixing techniques and use of suitable suspending agents.</p> Signup and view all the answers

    What are the three areas of knowledge that pharmacists and formulation scientists possess?

    <p>Physical pharmaceutics, chemical pharmaceutics, and biopharmaceutics</p> Signup and view all the answers

    What does the Medicines Act 1968 control?

    <p>Manufacture, Distribution, and Introduction of medicinal products</p> Signup and view all the answers

    What are the factors that affect the safety of medicines?

    <p>Correct drug, correct dose, correct method of delivery (correct label)</p> Signup and view all the answers

    What is the purpose of formulating a drug?

    <p>To ensure quality and safety</p> Signup and view all the answers

    What are the types of degradation that affect the shelf life of pharmaceutical products?

    <p>Chemical degradation, physical degradation, microbiological degradation</p> Signup and view all the answers

    What is the key consideration for manufacturing medicines in glass or plastic containers?

    <p>Cleanliness of the containers</p> Signup and view all the answers

    What is important in the preparation of suspensions to prevent clumping and uneven suspension?

    <p>Use of wetting agent</p> Signup and view all the answers

    What does formulation in pharmaceuticals involve?

    <p>Designing dosage forms to ensure biological and physical performance of the drug are met</p> Signup and view all the answers

    What is a disadvantage of using powders as a dosage form?

    <p>Faster decomposition compared to those in solid forms</p> Signup and view all the answers

    What method is used to reduce particle size by grinding with a mortar and pestle?

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

    What are the dosage forms mentioned in the text?

    <p>Suspensions, solutions, tablets, capsules, emulsions, powders, inhalers, linctus, injections, lotions, creams, suppositories, ointments</p> Signup and view all the answers

    What are the two types of suspensions mentioned in the text?

    <p>Flocculated suspension, deflocculated suspension</p> Signup and view all the answers

    What are the specific details that must appear on the label of a dispensed medicine according to the text?

    <p>The name of the preparation, The quantity, Instructions for the patient, The patient’s name, The date of dispensing, The name and address of the pharmacy, Warning or advisory labels, Batch or product number, Expiry date</p> Signup and view all the answers

    What is the preparation method for the 15% Chalk mixture requested for a specific patient?

    <ol> <li>Lightly mix 15g Chalk and 0.2g tragacanth in a porcelain mortar. 2. Add 50mL of double strength chloroform water gradually with mixing. 3. Pipette in 2.5mL of concentrated cinnamon water. 4. Caliber an amber bottle. 5. Rinse the mixture into the bottle with water. 6. Shake well.</li> </ol> Signup and view all the answers

    What is the expiry date and storage recommendation for the 15% Chalk mixture?

    <p>Expiry date of 2 weeks, Store in an amber bottle</p> Signup and view all the answers

    What is the dilution factor used to prepare 200 mL of peppermint water?

    <p>1+39</p> Signup and view all the answers

    What are the advantages of using powders as a dosage form according to the text?

    <p>Solid preparations are more stable than liquid formulations, Powders and granules are convenient forms for dispensing large doses, Powders have faster dissolution rates than tablets or capsules, Easy for compounding solids</p> Signup and view all the answers

    What are the disadvantages of using powders as a dosage form according to the text?

    <p>Less convenient for patients to carry, Problematic in masking unpleasant tastes, Unsuitable for potent drugs, Unsuitable for drugs inactivated in the stomach, Unsuitable for hygroscopic drugs</p> Signup and view all the answers

    What are the specific steps involved in the weighing preparation of powders according to the text?

    <p>Measuring, Sifting, Mixing, Reducing particle size by grinding with a mortar and pestle (trituration), Levigation, Uniform distribution using geometric dilution</p> Signup and view all the answers

    What is the specific method for handling hygroscopic and deliquescent powders as mentioned in the text?

    <p>Double wrapping for protection</p> Signup and view all the answers

    What are the key considerations for manufacturing medicines in glass or plastic containers according to the text?

    <p>Containers must be clean, Must not physically or chemically interact with the product, Caps should be closed tightly, Storage conditions should be mentioned</p> Signup and view all the answers

    What are the details that must appear on the label of a dispensed medicine according to the text?

    <p>The name of the preparation, The quantity, Instructions for the patient, The patient’s name, The date of dispensing, The name and address of the pharmacy, Warning or advisory labels, Batch or product number, Expiry date</p> Signup and view all the answers

    What are the specific details that must appear on the label of a dispensed medicine according to the text?

    <p>The name of the preparation, The quantity, Instructions for the patient, The patient’s name, The date of dispensing, The name and address of the pharmacy, Warning or advisory labels, Batch or product number, Expiry date</p> Signup and view all the answers

    What is the specific method for handling hygroscopic and deliquescent powders as mentioned in the text?

    <p>Double wrapping for protection</p> Signup and view all the answers

    What is the recommended shelf-life for the example of powders to be taken orally?

    <p>2-4 weeks</p> Signup and view all the answers

    What is the inert diluent used for the trituration of digoxin in the example of powders to be taken orally?

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

    What is the dilution factor used to prepare 10 powders each containing 200 micrograms of digoxin?

    <p>1 in 10</p> Signup and view all the answers

    Which method will be applied for mixing powders in the example of powders to be taken orally?

    <p>The geometric method</p> Signup and view all the answers

    What type of balance class will be used in the example of powders to be taken orally?

    <p>Balance class B (100mg)</p> Signup and view all the answers

    What is the advised application method for the zinc, starch, and talc dusting powder BPC?

    <p>Lightly dust the powder onto the affected area</p> Signup and view all the answers

    What are the points to be considered when formulating the example of powders to be taken orally?

    <p>Balance class B, 1 in 10 dilutions, geometric method for mixing powders</p> Signup and view all the answers

    What is the storage requirement for hygroscopic powders, if applicable?

    <p>Moisture proof and airtight</p> Signup and view all the answers

    What are the components of the Zinc, starch, and talc dusting powder BPC?

    <p>Zinc oxide, Starch, Sterilized purified talc</p> Signup and view all the answers

    What are the labels that should be used for the example of powders to be applied externally?

    <p>&quot;For external use only&quot;, &quot;Store in a cool and dry place&quot;</p> Signup and view all the answers

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