Design of Medicines Manufacturing Considerations 25

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118 Questions

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

Why design of medicines is important

What does formulation in pharmaceuticals involve?

Ensuring biological and physical performance of the drug

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

They are used when medicinal products are not available

What is the purpose of formulating a drug?

To achieve bioavailability, stability, and efficacy

When are extemporaneous preparations used?

When a specific patient requests it

What does pharmaceutical formulations involve?

Method of manufacture, ingredients, excipients, appearance, colour, and taste

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

Dispensing in small cellophane or polyethylene envelops

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

In a cool and dry place

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

For external use only

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

Lightly dust onto the affected area

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

Lactose

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

Balance class B (100mg)

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

1 in 10 dilution

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

Geometric method

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

2-4 weeks

How should the storage of hygroscopic powders be managed?

Storage should be moisture proof and airtight

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

Containers must not interact with the product and cause a change in quality.

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

The quantity and instructions for the patient

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

The expiry date must not exceed 2 weeks.

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

1+39

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

They are problematic in masking unpleasant tastes.

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

Levigation

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

'Hygroscopic and deliquescent powders'

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

The color of the medicine

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

They are more stable than liquid formulations.

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

Caps should be closed tightly to avoid premature degradation.

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

Chalk 15g, Powdered tragacanth 0.2g, Concentrated Cinnamon Water 2.5mL, Double strength chloroform water 50mL, Water to 100mL

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

Preparing powders as a dosage form

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

They have knowledge of physical, chemical, and biopharmaceutics

What does the Medicines Act 1968 control?

Manufacture, Distribution, and Introduction of medicinal products

What are the factors that affect the safety of medicines?

Correct drug, correct dose, correct method of delivery

What is important for the quality of medicines?

Operation of a Quality Assurance (QA) program

What is dependent on various factors when formulating a drug?

How a drug is formulated

What are some examples of dosage forms?

Suspensions, solutions, tablets

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

Does not exceed one month

What are suspensions?

Preparations containing fine drug particles distributed uniformly throughout a vehicle

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

Familiarity with properties of the dispersed phase and dispersed medium

What are shelf-life expiration dates calculated from?

Shelf-life at the time of preparation

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

True

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

False

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

False

Most medicines are manufactured under uncontrolled conditions.

False

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

False

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

True

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

True

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

True

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

False

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

True

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

False

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

False

Small scale products are used for centralized manufacturing.

False

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

False

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

False

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

True

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

True

Chalk mixture should be stored in a clear bottle.

False

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

False

Powders are more stable than liquid formulations.

True

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

False

Mortar and pestle are used for levigation in powder preparation.

True

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

False

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

False

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

True

Chalk mixture should be stored in a clear bottle.

False

Magnesium Trisilicate Mixture should be stored in a clear bottle.

False

Peppermint water is available as concentrated peppermint water only.

True

Pharmacists have knowledge of physical, chemical, and biopharmaceutics.

True

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

False

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

True

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

True

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

True

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

False

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

True

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

False

Adding a flocculating agent creates a deflocculated suspension.

False

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

True

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

False

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.

True

What is the purpose of formulating a drug in pharmaceuticals?

To achieve bioavailability, stability, and efficacy.

When are extemporaneous preparations used?

When medicinal products are not available.

What are the factors that affect the safety of medicines?

Correct drug, correct dose, and correct label.

What are some examples of dosage forms?

Tablets, capsules, powders, suspensions, emulsions, and ointments.

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

Levigation.

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

Proper mixing techniques and use of suitable suspending agents.

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

Physical pharmaceutics, chemical pharmaceutics, and biopharmaceutics

What does the Medicines Act 1968 control?

Manufacture, Distribution, and Introduction of medicinal products

What are the factors that affect the safety of medicines?

Correct drug, correct dose, correct method of delivery (correct label)

What is the purpose of formulating a drug?

To ensure quality and safety

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

Chemical degradation, physical degradation, microbiological degradation

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

Cleanliness of the containers

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

Use of wetting agent

What does formulation in pharmaceuticals involve?

Designing dosage forms to ensure biological and physical performance of the drug are met

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

Faster decomposition compared to those in solid forms

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

Levigation

What are the dosage forms mentioned in the text?

Suspensions, solutions, tablets, capsules, emulsions, powders, inhalers, linctus, injections, lotions, creams, suppositories, ointments

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

Flocculated suspension, deflocculated suspension

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

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

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

  1. 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.

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

Expiry date of 2 weeks, Store in an amber bottle

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

1+39

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

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

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

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

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

Measuring, Sifting, Mixing, Reducing particle size by grinding with a mortar and pestle (trituration), Levigation, Uniform distribution using geometric dilution

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

Double wrapping for protection

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

Containers must be clean, Must not physically or chemically interact with the product, Caps should be closed tightly, Storage conditions should be mentioned

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

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

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

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

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

Double wrapping for protection

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

2-4 weeks

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

Lactose

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

1 in 10

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

The geometric method

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

Balance class B (100mg)

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

Lightly dust the powder onto the affected area

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

Balance class B, 1 in 10 dilutions, geometric method for mixing powders

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

Moisture proof and airtight

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

Zinc oxide, Starch, Sterilized purified talc

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

"For external use only", "Store in a cool and dry place"

Test your knowledge of pharmaceutical manufacturing considerations including container material, cleanliness, interaction with products, sealing caps, and storage conditions for medicines. This quiz covers important aspects of pharmaceutical production processes.

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