capsule question and answer

capsule question and answer

Q.1 Which guidelines are commonly referred for capsule filling in pharmaceutical industry?

  1. Good Manufacturing Practices (GMP): GMP ensures that capsule filling facilities meet quality standards in areas like equipment, personnel, and documentation, maintaining product safety and efficacy.
  2. United States Pharmacopeia (USP): USP provides standards for capsule ingredients, manufacturing processes, and quality control tests to ensure capsules meet quality and purity requirements.
  3. International Conference on Harmonisation (ICH) Guidelines: ICH guidelines harmonize global regulations on stability testing, analytical procedures validation, and quality risk management, crucial for capsule manufacturing.
  4. Food and Drug Administration (FDA) Regulations: FDA regulations in the US mandate compliance with cGMP, quality systems, and validation requirements specific to capsule filling processes.
  5. European Medicines Agency (EMA) Guidelines: EMA guidelines in the EU cover manufacturing process validation, quality control, and registration requirements tailored to capsule products.

 

Q.2 Explain about some important tests done for Gelatin used for capsule shell in pharmaceutical industry?

 

Test

 

 

Acceptance Criteria

 

 

ReferenceSignificance

 

Bloom Test

 

 

 

Bloom strength > 200 g (for hard gelatin capsules)

 

USP/NF, Ph. Eur., JPMeasures the gel strength and elasticity of gelatin. Higher Bloom strength indicates greater gel strength, crucial for capsule integrity.

 

 

Viscosity

 

 

 

40-48 mm (for Type A gelatin, 6.67% solution, 60°C)

 

Ph. Eur., JP

 

Evaluates the viscosity of gelatin solutions, ensuring proper coating or encapsulation during manufacturing.

 

 

Iron Content

 

≤ 0.0015% (15 ppm)

 

USP/NF, Ph. Eur., JP

 

Determines the presence of iron impurities, which can cause discoloration or degradation of gelatin capsules and pose safety

 

 

 

 

Q.3 How gelatin is manufactured and what are the major two types of gelatin?

Gelatin is prepared from collagen (Collagen is a type of protein found in the bodies of animals, including humans. It’s found in our skin, bones, muscles, tendons, and ligaments.) Through a process involving extraction from animal tissues, followed by hydrolysis, filtration, concentration, drying, grading, and packaging.

  1. Type A Gelatin: This type of gelatin is derived by acid processing. It has an isoelectric point between pH 7 and 9.
  2. Type B Gelatin: Derived by alkaline processing, type B gelatin has an isoelectric point between pH 4.8 and 5.2.

 

  1. 4 How do you address issues such as powder segregation and capsule weight variation during capsule filling?
  2. Use uniform and properly blended powder formulations. 2. Optimize the powder flow characteristics to minimize segregation.
  3. Regularly monitor and adjust the machine settings to maintain consistent capsule weights.
  4. Implement in-process controls such as weight checks and visual inspections to detect and correct variations promptly.
  5. 5 What are the commonly used material for polishing of filled capsule in pharmaceutical industry?

Hard gelatin capsules are polished before final packaging to remove any adhering particles and make them glossy.

  1. Microcrystalline Cellulose (MCC)
  2. Talc
  3. Magnesium Stearate
  4. Silicon Dioxide (Silica)
  5. Polyethylene Glycol (PEG)
  6. Glycerin
  7. 6 Why polishing of filled capsule is done in pharmaceutical industry?
  8. Aesthetic Appeal: Polishing gives capsules a smoother, more attractive look, crucial for consumer perception. 2. Removal of Imperfections: It eliminates dust particles and uneven surfaces, ensuring uniformity and quality.
  9. Enhanced Lubrication: Polishing with lubricants reduces friction, improving capsule flow and dispensing.
  10. Quality Assurance: By visually inspecting and polishing, manufacturers identify and remove defective capsules, maintaining high standards.

 

  1. 7 Who are the major suppliers for Capsule Filling machine in pharmaceutical industry?

Top 5 Suppliers for capsule filling machine in India

  1. ACG Worldwide 2. NKP Pharma
  2. IMA Pharma 4. SaintyCo
  3. Pharma Technologies

Top 5 Suppliers for capsule filling machine in World

  1. Bosch Packaging Technology (now part of Syntegon Technology)
  2. IMA Pharma
  3. Capsugel (now part of Lonza)
  4. MG America
  5. ACG Worldwide

 

  1. 8 Who are the leading suppliers of Gelatin for capsule shell in pharmaceutical industry?

Worldwide

  1. Capsugel (now Lonza Capsules)
  2. CapsCanada Corporation
  3. ACG Worldwide
  4. Qualicaps.
  5. Roxlor LLC

India

  1. Suheg Pharma Pvt. Ltd.
  2. Healthcaps India Ltd.
  3. Sunil Healthcare Ltd.
  4. Nectar Lifesciences Ltd.
  5. Medgel Pvt. Ltd.

 

 

Q.9 What is typical moisture content in hard gelatin capsule?

The typical moisture content in hard gelatin capsules ranges from 12% to 16%, measured in percentage (%).

 

Q.10 What are the advantages and disadvantages of capsule dosage form?

Advantages

  1. Ease of Swallowing: Capsules are easier to swallow than tablets, beneficial for individuals with swallowing difficulties.
  2. Taste Masking: Capsules effectively mask unpleasant tastes of drugs, enhancing patient compliance.
  3. Flexible Formulation: Capsules accommodate various formulations, offering flexibility in drug delivery. 4. Reduced Drug Interactions: Capsules may have fewer drug interactions compared to tablets.

Disadvantages

  1. Limited Dose Uniformity: Variability in capsule content can lead to inconsistent dosing.
  2. Digestive Variability: Capsule dissolution rates may vary, impacting drug absorption.
  3. Hygroscopic Sensitivity: Capsule materials can absorb moisture, affecting stability.
  4. Specialized Equipment Required: Capsule manufacturing needs specialized equipment, increasing costs.

 

  1. 11 What are the major parts of capsule filling machine?
  2. Hopper/feeder: This is where the empty capsules

are stored before they are filled.

  1. Capsule Orientation Station: This part ensures that the capsules are properly oriented before filling. 3. Dosing Disk: It’s responsible for precisely metering the amount of powder or granules to be filled into each capsule.
  2. Tamping Pins or Tamping Plate: These components compress the filled powder or granules to ensure uniformity and proper filling density.
  3. Closing Station: This part seals the filled capsules, usually by joining the capsule halves together. 6. Ejection System: It removes the filled and sealed capsules from the machine, ready for further processing or packaging.
  4. Control Panel: This allows operators to monitor and adjust various parameters such as filling speed, dosage, and machine operation

 

 

Q.12 What are the different parts of Hard gelatine capsule ?

body

cap

 

Q.13 What is difference between body part and cap part of empty gelatin capsule ?

AspectBody part of capsuleCap part of capsule
Size

 

Typically larger in size

 

Smaller in size

 

Shape

 

Usually longer and cylindrical

 

Shorter and hemispherical

 

Compatibility

 

Holds more filling material

 

Holds less filling material

 

FunctionEncloses the majority of the filling

 

Encloses a smaller portion of filling

 

Assembly

 

Attached to the cap during filling

 

Separately filled and then joined

 

 

 

Q.14 What is basic difference between hard gelatin capsule and Soft gelatin capsule ?

AspectHard gelatin capsuleSoft gelatin capsule
Composition

 

It is madeof 2 pieces

 

Made of single pieces of hard gelatin

 

Shell flexibilityRigid and firm

 

Flexible and elastic
ContentsTypically contain dry powders or granules

 

Contain liquid or semi-solid formulations

 

Manufacturing Process

 

Require higher compression force during manufacturing

 

Formed through encapsulation in a mold and drying process

 

ApplicationSuitable for non-aqueous, solid or dry and for drugs with poor solubility or

Applications

 

Ideal for liquid or semi-solid formulations,

and for drugs with poor solubility or

Applications