What are the factors which influence tablet hardness?
Compression Force
Binder quantity (More binder more hardness)
Moisture content
Too little or improper lubrication.
Too much binder
Hygroscopic granular
Which type of tablets are exempted from Disintegration testing?
Chewable Tablets
What is the recommended temperature for checking DT of a dispersible tablet?
25 ±1°C (IP)
15 – 25°C (BP)
List out the appearance defects of tables during compression activity.
Capping: ‘Capping’ is the term used, when the upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling.
Lamination / Laminating: ‘Lamination’ is the separation of a tablet into two or more distinct horizontal layers.
Sticking/filming: ‘Sticking’ refers to the tablet material adhering to the die wall. Filming is a slow form of sticking and is mainly due to excess moisture in the granulation.
Cracking: Small fine cracks were observed on the upper and lower center surface of the tablets, or very rarely on the side wall is referred to as cracks.
Chipping: ‘Chipping’ is defined as the breaking of tablet edges, while the tablet leaves the press or during subsequent handling and coating operation.
Mottling: 'Mottling’ is the term used to describe an unequal distribution of color on a tablet.
Double Impression: ‘Double impression’ involves only those punches, which have a monogram or other engraving on them.
What are the recommended storage conditions for empty hard gelatin capsules?
15 - 25°C & 35 -55% RH
When performing the ‘uniformity of weight of the dosage unit, how many tablets/capsules can deviate from the established limit?
Not more than two of the individual weights can deviate from the average weight by more than the percentage given in the pharmacopeia, and none can deviates more than twice that percentage.
Weight Variation limits for Tablets
Weight Variation limits for Capsules
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What is the reason to maintain pressure gradients?
In tablet manufacturing facilities, pressure gradients are maintained to avoid cross-contamination of products through air. Usually, processing areas are maintained under positive pressure with respect to service corridors.
What are the basic differences between Elixir and Suspension?
In an elixir, the active ingredients are mixed with a liquid, usually a kind of syrup or alcohol, in which they can dissolve.
In a suspension, the medicine is mixed with a liquid, usually water, in which it cannot dissolve and therefore remains intact in the form of small particles. The important thing to remember is that you have to shake a suspension before giving each dose so that the medicine particles are evenly distributed throughout the liquid.
What do you mean by DQ, IQ, OQ, & PQ?
Design Qualification (DQ): documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose.
Installation Qualification (IQ): documented verification that the equipment or systems are installed or modified & comply with the approved design of the manufacturer’s recommendations and/or user requirements.
Operational Qualification (OQ): documented verification that the equipment or systems are installed or modified & perform as intended throughout the anticipated operating ranges.
Performance Qualification (PQ): documented verification that the equipment and ancillary systems are connected & can perform effectively and reproducibly based on the approved process method and specifications.
Write the functions & use of the HVAC system.
A heating, Ventilating, and Air conditioning system is used for temperature and humidity control within a manufacturing environment. It includes air handling units, an air distribution network, an air-cooling, and heating system, air filtration, an equipment control system, monitoring, and alarm decreases
What is Clean Room & Aseptic Area?
Clean Room:
A room in which the concentration of airborne particles is controlled to meet specified airborne particulate cleanliness class. In addition, the concentration of microorganisms in the environment is monitored; is cleanliness class defined is also assigned a microbial level for air, surface, and personnel gear.
Aseptic Area:
Any area in an aseptic process system for which airborne particulate and microorganism levels are controlled to specific levels appropriate to the activities conducted within that environment.
Which type of water is used in sterile preparation?
Water for Injection (Bulk)
- Characters: A clear, colorless, odorless and tasteless liquid.
- Nitrates: Not more than 0.2 ppm
- Heavy metals: Not more than 0.1 ppm
- Conductivity: Conductivity at 20°C not more than 1.1 μS.cm-1.
- Microbial Contamination: Total viable aerobic count should be less than 10 micro-organisms per 100 ml. Absence of E. Coli, Salmonella, Staphylococcus aureus & Pseudomonas.
- Bacterial endotoxins-Less than 0.25 IU per ml.
The addition of a 0.01 gm equivalent of sodium hydroxide to 0.25 L of a buffer solution produced a PH of 0.50. What will be the buffer capacity?
(0.01/0.25)/0.50= 0.08(Eq/L)/ PH chnage
Accurately weigh an amount of Lithium Citrate USP (Containing 2.5% moisture as stated in the certificate of analysis) to obtain 200 mEq of Lithium. (Note: 1 mEq Lithium is equivalent to 0.00694 gm of Lithium)
W= Weight in gram of Lithium Citrate USP
A= 200 eEq of Li+ or 1.39 gm of Li+
B= 282 g/mole
D= 0.975
E= 3 x 6.94 g/mole or 20.8 g/mole
W= 1.39 g (282 g/Mole) / 0.975 (20.8 g/mole) = 19.3 gm
What are the packaging component of Aerosol?
- Propellant
- Container
- Valve and actuator
- Product concentrate
How many grams of dextrose are required to prepare 4000 ml of 8% solution?
g. solute = 4000 x = 200 g
S g. = 100 ml , X = 4000 ml
X = 4000 x S/100 = 200 g
Peppermint spirit contains 10% (v/v) of peppermint oil. What volume of spirit contains 75 ml of the active ingredient?
Volume in ml = 75/0.1 =750 ml
What are the differences between Ointment & Cream?
What s Vortex?
In fluid dynamics, a vortex is a region within a fluid where the flow is mostly a spinning motion about an imaginary axis, straight or curved.
Write down the tablet manufacturing process.
How many Methods of Sterilization are involved in pharmaceutical plants?
Physical Method
Thermal (Heat) methods
Radiation method
Filtration method
Chemical Method
Gaseous method
What is BFS technology?
BFS means Blow Fill Seal. This technology is usually used for sterilized product like ophthalmic drops, where container preparation, material fill, and sealing all happen at a time.
What are the main components of Effervescent tablets?
The effervescent tablet mainly consists of three components:
- Active ingredient;
- Acid source;
- Alkaline compound, constituted by carbonate or bicarbonate
What is Lyophilization?
In Lyophilization, or freeze drying, there is water is frozen, followed by its removal from the sample, initially by sublimation (primary drying) and then by desorption (secondary drying). In this process, the moisture content of the product is reduced to such a low level that does not support biological growth or chemical reactions which gives stability to the formulation. This technique is useful in the formulation development of drugs that are thermolabile and/or unstable in an aqueous medium.
Define primary and secondary packaging.
The primary packaging consists of those packaging components which have direct contact with the product (i.e. bottle, cap, cap liner, label etc).
The secondary packaging mainly provides the additional physical protection necessary to endure safe warehousing and for refill packaging.
Define the Strip package and Blister package.
Strip packages have at least one sealed pocket of material with each pocket containing a single dose of the product. The package is made of two layers of film or laminate material. The nature and level of protection which is required by the contained product will affect the composition of these layers.
Blister packages are composed of a base layer, with cavities called blisters which contain the pharmaceutical product, and a lid. This lid is sealed to the base layer by heat, pressure, or both. They are more rigid than strip packages and are not used for powders or semi-solids. In tropical areas blister packages with an additional aluminum foil is used which provides greater protection against high humidity.
PEG is …………. surfactant.
- anionic
- anionic & cationic depending on pH
- non-anionic
- cationic
The alcohol content in an elixir is not more from
70%
60%
50%
40%
Water no. of a formulation can be increased by the addition of:
Alcohol
Glycerin
Surfactant
Emulsion
The alcoholic solution is milky with the compound:
Glutethimide
Paraldehyde
Chlorambucil
Chloral hydrate
Rancidity of fat is due to :
Oxidation
Hydrolysis
Saponification
Neutralization
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