A leading pharmaceutical company in Bangladesh established in the year 1991. The manufacturing facility located at Sitakund which is 35 kilometers away from center of the main port city of Bangladesh called Chittagong. The company produces & marketing various types of dosage forms which includes tablet, capsule, liquid syrup, dry syrup, cream, ointment, gel, injectable and ophthalmic products etc. Since its incorporation, ALBION always focuses on new molecules and new generation products which results in total number of registered products more than 350 from Directorate General of Drug Administration.
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albion.docx
1. Environmental Observation
Observation depends on the following criteria
Humidity:45±5%
Temperature:22±20C
Different condition in various portion:
Type Humidity Temperature
Tablet less than 50% less than 250C
Capsule less than 50% less than 250C
Dry syrup less than 45% less than 250C
Vial less than 40% less than 250C
2. Formulation of Liquid
In medical terminology, medicinal syrups or syrupus are nearly
saturated solutions of sugar in water in which medicinal substances or
drugs are dissolved. The medical syrup or pharmaceutical syrup is
actually used as a vehicle for medicine.
In other words, syrup is a concentrated or nearly saturated solution of
sucrose in water. A simple syrup contains only sucrose and purified
water (e.g. Syrup USP). Syrups containing pleasantly flavored substances
are known as flavoring syrups (e.g. Cherry Syrup, Acacia Syrup, etc.) A
viscous concentrated solution of a sugar, such as sucrose, in water or
other aqueous liquid; combined with other ingredients, such a solution
is used as a flavored vehicle for medications. In common usage, the
3. term is often expanded to include any oral dosage form (for example, an
oral suspension) in a sweet and viscous vehicle.
Method of Preparation of syrup
Four methods are commonly used for preparation of syrups
o Agitation without Heat: This method is used for the preparation of
syrups containing volatile substances. ...
o Solution with heat: ...
o Addition of a medicated liquid: ...
o Percolation
Different types of syrup
4. Simple Syrup. When Purified Water alone is used in making the
solution of sucrose, the preparation is known as “syrup,” or
“simple syrup.
Medicated syrup. When Syrup contains medicinal substance is
know as medicated syrup – cough syrup.
Flavoured Syrup.
5. Suspension
A Pharmaceutical suspension is a coarse dispersion in which internal phase is
dispersed uniformly throughout the external phase.The internal phase
consisting of insoluble solid particles having a specific range of size which is
maintained uniformly through out the suspending vehicle with aid of single or
combination of suspending agent.
The external phase (suspending medium) is generally aqueous in some
instance, may be an organic or oily liquid for non oral use.
#Requirements of Suspension System
There should be minimum deflection.
It should be of minimum weight.
It should have low maintenance and low operating cost.
It should have minimum tyre wear.
It should be of low initial cost.
6.
7. Powder for suspension
Figure: Flowchart showing Powder for Suspension Filling
Dispensing
Sieving
Dry mixing
Filling
Cap sealing
Packaging
8. Dry Syrup
Dry syrup refers to medicine that is contained in powder form. To administer dry syrup the powder
medication is dissolved in water. This form of medication is best for treatment of children owing to
its relative easiness to administer in comparison to other forms of medicine.
Physical Plant design
constructed into two segment
Manufacturing area
Filling and sealing area
9. Manufacturing Flow Chart
Sieving of ingredients
With different sieve size
All ingredient Blending
Filling of dry syrup in bottle
Sealing of Bottles
Checking
Packing
Q.C analysis
Bottle
washing
and
Drying at
1300
C
10. Filling room condition
Temperature: must maintain between 20 to 250C
Relative Humidity: not exceed 50%
In process control parameter
Manufacturing : Relative Humiduty should not exceed 50% and temperature should in
between 25-280C
Filling/Sealing: Weight variation, relative humidity , temperature and sealing check.