Pharmaceutical Technology

1. What do you mean by Pharmaceutical Technology ?

Answer:

Pharmaceutical Technology is the part or branch of pharmacy that focused on the formulation of medicine and drug delivery for the best quality of the treatment and management of disease.

Pharmaceutical Technology is the application of scientific knowledge or technology to pharmacy, pharmacology, and the pharmaceutical industry. It includes methods, techniques, and instrumentation in the manufacture, preparation, compounding, dispensing, packaging, and storing of drugs and other preparations used in diagnostic and determinative procedures and in the treatment of patients.

2. Define tablet, capsule, gelatin and collagen.

Answer:

• Tablet: a compressed solid substance, typically a measured amount of a medicine or drug.
• Capsule: a solid dosage forms made from gelatin or other suitable material which is filled with medicines to produce a unit dose.
• Gelatin: a substance of natural origin that prepared by the hydrolysis of collagen.
• Collagen: the main protein constituents of connective tissue (Main source of collagen: Animal skin, bone, connective tissue).

3. Mention the capsule size for humans and animals.

For humans:

Size - Body volume (ml)
0 - 0.67
1 - 0.48
2 - 0.37
3 - 0.28
4 - 0.20
5 - 0.10

For animals:

Size - Body volume (ml)
000 - 1.37
00 - 1.02


4. Define dryer. Mention different types of dryer.

Answer:
Dryer: is an equipment that is used for drying wet materials.

Different types of dryer:

• Static bed dryers [no relative movement among the solid particles being dried]
• Moving bed dryer [flow over each other]
• Fluidized bed dryer [solid particles are partially suspended in an upward moving gas stream]
• Special drying methods [ Freeze dryer, Microwave drying]

5. What is the importance of drying ?

Answer:

• Preparation of bulk drugs
• Preservation of drug products
• Improved characteristics
• Improved handling

6. What is the principle of Fluidized Bed Dryer ?

Answer:
Systems in which the solid particles are partially suspended in an upward moving gas stream. In this dryer hot air (gas) is passed at high pressure through a perforated bottom of the container containing granules to be dried. The granules are suspended in the stream of air. This condition is called fluidized state.


7. What do you mean by freeze drying ? Mention the steps of freeze drying process.

Answer:
Freeze drying: is a conduction drying method that is operated under vacuum followed by heat transfer in the dryers.

Freeze drying process:

Freezing 

↓

Vacuum

↓

 Primary drying/Sublimation phase 

↓

Secondary drying/Ordinary vacuum drying 

↓

Packaging 

↓

Storage

↓

 Reconstitution phase

8. Mention the steps of tablet formulation.

Answer:

1.  Dispensing of Raw materials 
2. Granulation 
3. Compression

9. Mention the parts of tablet compression machine.

Answer:

1. Hopper (for holding and feeding granulation)
2. Dies (to define the size and shape of the tablet)
3. Punch - (upper and lower punches compress the granules) 
4. Feeder housing 
5. Feed paddles (for moving granules)
6. Cam track (for guiding the movement of the punches)
7. Compression roller 
8. Discharge chute 
9. Ejection cam

10. What do you mean by mill ? What are the actions & uses of Cutter, Revolving, Hammer, Rolar, Attrition & Fluid energy mills?

Answer:
Mill: Equipment used to reduce the particle size of solids. Solid particles present in semisolids and suspensions can be reduced by using specially designed machine (Mills).

Characteristics of various types of mills are given below:

1. Cutter

• Action: cutting
• Used for: Fibrous, crude animal and vegetable drugs.

2. Revolving

• Action: Attrition and impact
• Used for: Fine grinding of abrasive material

3. Hammer

• Action: Impact
• Used for: Almost all drugs

4. Rolar

• Action: Pressure
• Used for: Soft materials

5. Attrition

• Action: Attrition
• Used for: Soft and fibrous material

6. Fluid-energy

• Action: Attrition and impact
• Used for: Moderately hard and friable material.

11. Describe compression machine tooling.

Answer:

1. 'B' tooling (Maximum tablet size 16 mm)
2. 'D' tooling (Maximum tablet size 25 mm)
3. 'BB' tooling (Maximum tablet size 13 mm)
4. 'DB' tooling (Maximum tablet size 19 mm)

12. What are the process equipments of coating ?

Answer:
Most coating processes use one of three general types of equipment:

1. The standard coating pan
2. The perforated coating pan
3. The fluidized bed coater

13. Define microcapsulation. Mention the application of microcapsulation.

Answer:
Microcapsulation: is a process by which solids, liquids, or even gases may be enclosed in microscopic particles by formation of thin coatings of wall material around the substance. A capsule with a size range about 200µ is termed as microcapsule.

Applications:
Encapsulation is a fairly standard practice in the food, consumer product, and cosmetics industries because this process can protect and enhance stability as in the foods and vitamins.


14. Mention the process of microencapsulation.

Answer:

• Air suspension: consists of the dispersing of solid, particulate core materials in a supporting air steam and the spray-coating of the air suspended particles.
• Pan coating: with respect to microencapsulation, solid particles greater than 600 micrometer in size are generally considered essential for effective coating, and the process has been extensively employed for the preparation of controlled-release beds.
• Spray drying and spray congealing: are similar in that both involve dispersing the core material in a liquefied coating substance and spraying or introducing the core-coating mixture into some environmental condition.
• Solvent evaporation: the microcapsule coating is dissolved in volatile solvent. The mixture is then heated to evaporate the solvent for the polymer.

15. Define clearly: Solution, Suspension, Emulsion, Multi-emulsion, Micro-emulsion, Tinctures, Syrups and Elixir.

Answer:

• Solution: is a homogenous mixture prepared by dissolving a solid, liquid or gas in another liquid. (Molecule in size)
• Suspension: may be defined as a biphasic system comprising of a solid phase uniformly dispersed in a liquid phase. (Larger than 10,000 Angstroms)
• Emulsion: may be defined as a biphasic system comprising of two immiscible liquids usually water and oil, one of which is finely subdivided and uniformly dispersed as droplets throughout the other.
• Multi-emulsion: in which oil in water or water in oil emulsion are dispersed in another liquid medium.
• Micro-emulsion: contains globules having diameters of less than 0.1 micrometer.
• Tinctures: are alcoholic or hydro alcoholic solutions of chemicals or soluble constituent of crude drugs.
• Syrups: are viscous sweet concentration solutions of sugar such as sucrose in water. Syrup BP is 66.7% solution of sucrose.
• Elixir: Clear, sweetened, hydro alcoholic liquid intended for oral use.

16. What do you mean by semi-solid preparation ? Define: Ointment, Cream, Lotion, Liniment, Paste, Gels, Gullies and Poultices.

Answer:

• Semi-solids: are neither solid nor liquid. They are in between the two. They should be smooth, uniform mixture, easily washable, non irritant and not be sticky.
• Ointments: are hydrophobic type of preparation and are mainly composed of hydrocarbons, mineral oils or petrolatum.
• Creams: are semisolid preparations. They are used externally and contain one or more medicinal agents dissolved or dispersed in either a w/o or o/w emulsion base or in a water washable base.
• Lotions: are similar to solution but are thicker and tend to be emollient in nature than solution.They are usually oil mixed with water.
• Liniment: is a medicated topical preparation for application to the skin.
• Pastes: are dilute preparations. Where insoluble solids are dispersed in the continuous phase in large extent. These are less viscous, less sticky and slurry type.
• Gels: are at least two component mixtures where one component is constrained within a three dimensional polymeric matrix of the other which is in general is the vehicle.
• Gullies: are transparent or translucent non greasy semisolid gel.
• Poultices: are the ready-made home made preparations that are still in use today.

17. What is aerosol ? Mention the components of aerosol.

Answer:
Aerosol: Aero means air, Sol means solution. Aerosol is a solution of air. It can be defined as the system that depends on the power of compressed to expel the content from the container.

• Aerosol have site specific (local) action.
• It has less side effects.
• Rapid onset of action.

Components of Aerosol:

• Active ingredient
• Propellant
• Container
• Valve and Actuator
• Product concentrate

Propellant: regarded as the heart of the aerosol package. Because propellant is responsible for developing the proper pressure within the container.


18. What do you mean by DPI ? Describe the formulation of DPI ?

Answer:
DPI: is a device that delivers medication to the lungs in the form of a dry powder. DPIs are commonly used to treat respiratory diseases such as asthma, bronchitis, emphysema and COPD.

Formulation design:

• Low aerodynamic diameters.
• Low inter-particulate forces.
• Dry powder particles of suitable size range, generally considered between 1 and 6 micrometer.

19. What do you mean by MDI? Write down the uses of MDI.

Answer:
MDI: A metered-dose inhaler (MDI) is a device that delivers a specific amount of medication to the lungs, in the form of a short burst of aerosolized medicine.

Uses: It is the most commonly used delivery system for treating asthma, COPD and other respiratory diseases.


20. What is parenteral product? Which factors must be considered for the preparation of parenteral products?

Answer:
Parenteral products: are sterile solutions or suspensions of drugs in aqueous or oily vehicles that are injected through the skin or mucous membrane into internal body compartment. They may produce immediate responses.

The following factors must be considered for the preparation of parenteral products:

• Volume of injection
• Adjustment of pH
• Stabilizer
• Preservatives
• Adjustment of specific gravity
• Adjustment of isotonicity
• Vehicles

21. Mention the aqueous vehicles that are used for the preparations of parenteral products.

Answer:
Water for injection U.S.P

• This water is purified by distillation or reverse osmosis or diamination.
• It is well tolerated by the body.
• It is not required to be sterile but must be pyrogens free.

Sterile water for Injections U.S.P

• This water has been sterilized and packaged in single-dose containers of not more than 1 liter size.
• It must be pyrogens free.

Bacteriostatic Water for Injections U.S.P

• This water is sterilized water for injection containing one or more suitable anti-microbial agents.
• It is packaged in vials containing not more than 30 ml of the water.

Sodium Chloride (NaCl) Injections U.S.P

• It is sterile and isotonic solution of NaCl in water for injections.

22. Classify parenteral product according to the volume.

Answer:
Parenteral product can be divides into two general classes according to the volume:

1. Small volume parenteral (usually 100 ml or less)
2. Large volume parenteral (more than 100 ml)

23. What is opthalmic product? Mention the different types of opthalmic preparation.

Answer:
Opthalmic preparations: are the solid, semi-solid or liquid specialized dosage form designed to be installed onto the external surface of the eye.

Types of opthalmic preparation:

• Eye drops
• Eye lotions
• Eye ointments
• Contact lenses solutions
• Opthalmic inserts

24. What do you mean by blood? Write down the name of blood product.

Answer:
Blood: is a red, thick and slightly alkaline (pH 7.46-7.48) fluid connective tissue. In blood cell components (RBC, WBC, Platelets) are suspended in liquid substance (plasma). An adult human contains about five liters of blood. The composition of blood is - Cell compound (45%) & Plasma (55%).

Types of blood products:

• Blood
• Blood plasma
• Plasma fraction
• Artificially synthesized blood products

25. What do you mean by implant & Suppository.

Answer:
Implants: are drug bearing polymeric device which are implanted subcutaneously or in various body cavities. Examples include: Insulin for diabetes, Contraceptive steroids, Narcotic antagonists.

There are four types of implantable devices based on the site of implantation:

• Subcutaneous devices
• Intravaginal devices
• Intrauterine devices
• Intraocular devices

Suppository: is a solid dosage forms intended for insertion into body orifices where they melt, softer or dissolve and exert localized or systemic effects. Suppositories are commonly used in -

• Rectally
• Vaginally
• Occasionally Urethrally

26. Write down the chemical name of the followings.

Answer:

Name of the material [Chemical name]

• Iso-propyl alcohol [Propan 2-ol]
• Alcohol [Ethanol]
• Acetone [2-Propanone]
• Calcium carbonate [Carbonic acid]
• Dextrose [D-(+)-Glucose monohydrate]
• Fructose [D-Fructose]
• Glycerin [Propane 1,2,3 -triol]
• Methyl paraben [Methyl 4-hydroxy benzoate]
• Propyl paraben [Propyl 4-hydroxy benzoate]
• Kaolin [Hydrate aluminum silicate]
• Sorbitol [D-Glucitol]
• HPMC [Cellulose hydroxy propyl methyl ether]
• Propylene glycol [1,2 -Dihydroxypropane]
• Stearic acid [Octadecanoic acid]
• Sucrose [B-D-fructosefuranosyl-a-D-glucopyranoside]

27. Define preformulation. What are the purpose of preformulation.

Answer:
Preformulation: Before the formulation of a new drug substance into a dosage form, it is essential to ascertain certain fundamental physical and chemical properties of the drug powder.

Purpose of the preformulation studies

• To study the physicochemical properties of the drug.
• To provide a rationale for formulation design.
• To support the need for molecular modification.

28. What do you mean by ware house? What are the functions of ware house ?

Answer:
Ware house is the department where the raw and packaging materials are store which comes from the supplier, dispensed in the production area and finished products are deliver through this area.

Functions of ware house

1. Storage of raw & packaging materials.
2. Temporary storage of finished product before going central depot.
3. Storage of rejected materials before disposals.
4. Maintain proper quality during the storage of material.

29. What do you mean by packaging ? 

Answer:
Packaging: is the process by which the pharmaceuticals are suitably packed so that they should retain their therapeutic effectiveness from the time of their packaging till they are consumed.

Packaging materials

• Container (Glass, Plastic, Metals)
• Closure (Glass, Plastic, Rubber, Cork)
• Carton
• Box

Aim of packaging

• Protection
• Identification
• Presentation

30. What do you mean by container ? Classify Container.

Answer:
Container: may be defined as a device in which the drug is enclosed and is in direct contact with the drug.

Classification:

• Well closed container
• Air-tight container
• Hermetically-sealed container
• Light resistant container
• Single dose container
• Multi-dose container
• Aerosol container

31. Describe different glass compounds.

Answer:
Glass compounds: is the first preferred materials of container for parenteral products. Glass is composed principally of the silicon-dioxide (SiO2) tetrahedron.

Classification:

1. Type I glass (Borosilicate glass)
2. Type II glass (Treated soda lime glass)
3. Type III glass (Regular soda-lime glass)
4. NP glass (Non parenteral glass)

32. What do you mean by Plastic, Closure, Strip pack and Blister pack.

Answer:
Plastic: is a material that contains as an essential ingredient one or more polymeric organic substances of large molecular weight. They are sensitive to heat and may melt or soften at below 100ºC.

Closure: is normally most vulnerable and critical component of a container. An effective closure must prevent the contents from escaping and allow no substance to enter the container.

Strip pack: one or more sealed pockets of materials, each of which contains a single dose of the product.

Blister pack: consists of a base layer, which contains cavities containing pharmaceutical products and a lid that is sealed by heat, pressure or both. Composition: Aluminum, PVC/PVDC, Polypropylene.

33. What are the responsibilities of Production Executive.

Answer:

• Management of day to day production activity.
• Organize the daily or periodic production program as per monthly production plan.
• Maintain Good Manufacturing Practice (GMP), cGMP in all operations of the section.
• Maintain BMR and BPR.

34. Differentiate between ointment & cream, jallies and pastes, Elixir and Syrups.

Answer:
Cream 

• Creams are viscous semisolid preparation 
• Due to presence of water soluble base creams are easily removable. 
• Multiphase preparation 

Ointment 

• Ointment are semisolid preparation but not viscous. 
• Ointment are not easily removable 
• Monophase preparation 

• Jellies are transparent or translucent & non-greasy 
• Pastes are not transparent and less-greasy 

• Elixir are clear, pleasantly flavoured, sweetened hydroalcoholic liquid preparations for oral administration. The main ingredients of elixir are ethanol and water. 
• Syrups are sweet, viscous, concentrated aqueous solutions, usually contain water and other aqueous vehicle.