CHAPTER 1

KSDPL AN OVERVIEW
1.1. INTRODUCTION
Kerala State Drugs and Pharmaceuticals Ltd, a public sector undertaking, since its
inception in 1974 has been manufacturing and supplying essential and life saving
medicines to cater the need of the common patients resorting to Government hospitals
in the state of Kerala. As Kerala is a leading state in public health services, KSDPL
have been under constant pressure to achieve the best of Quality standards. In fact
their logo is Quality that cures with a highly dedicated workforce and professional
supervision and with their old tradition of providing appropriate coverage without fall.
They do in fact produce medicines that Cure rather than Treat.
The company has reached glorious heights in its way to thrive in this Hi-tech era. The
product development wing of the company has made all efforts to bring out scores of
new products in addition to the existing multiplicity of drug formulations to the tune
of hundred odd products. The development work of new generation drugs are in
progress.
Now the company is a major supplier of quality drugs to Kerala State Medical Service
Corporation (KMSCL), Thiruvananthapuram.
Without any compromise in quality, KSDPL is shielding itself from the globalisation
threats and venturing into commercial trade operations.
1.2. PRODUCTS BY KSDPL
KSDP LTD., an enterprise fully owned by the Government of Kerala Manufacturing
Quality Drugs of various formulations like Tablets, Capsules, Liquid Orals, External
Preparations, Powders, ORS, Injectables etc. from 1974 onwards.

The various products are listed below:

1.2.1. CAPSULES
Amoxycillin Capsules I.P.

250mg.

Amoxycillin Capsules I.P.

500mg.

Ampicillin Capsules I.P.

250mg.

Cloxacillin Capsules I.P.

250mg.

Doxycycline Capsules I.P.

100mg

Omeprazole Capsules I.P.

20mg.

1.2.2. TABLETS
Acetylsalysalic Acid Tablets I.P.

300mg.

Alprazolam Tablets I.P.

0.5mg.

Amlodipine Tablets I.P.

2.5mg.

Amlodipine Tablets I.P.

5mg.

Amoxycillin Dispersible Tablets I.P.

125mg

Atenolol Tablets I.P.

50mg.

Azithromycin Tablets I.P.

250mg.

Azithromycin Tablets I.P.

500mg.

Cetrizine Tablets I.P.

10mg.

Ciprofloxacin Tablets I..P.

500mg.

Co-Trimoxazole Tablets I.P.

160/800mg.

Chlorpheneramine Maleate Tablets I.P.

2mg.

Diethyl Carbamazine Citrate Tablets I.P.

100mg.

Diazepam Tablets I.P.

5mg.

Diclofenac Sodium Tablet I.P.

50mg.

Dicyclomine HCL Tablets I.P.

10mg.

Erythromycin Stearate Tablets I.P.

250mg.

Folic Acid Tablets I.P.

5mg.

Frusemide Tablets I.P.

40mg.

Glibenclamide Tablets I.P.

2.5mg.

Glibenclamide Tablets I.P.

5mg.

Ibuprofen Tablets I.P.

200mg.

Ibuprofen Tablets I.P.

400mg.

Metformin Tablets I.P.

500mg.

Metoclopramide Tablets I.P.

10mg.

Metronidazole Tablets I.P.

200mg.

Metronidazole Tablets I.P.

400mg.

Nifedepine Tablets I.P.

10mg.

Norfloxacin Tablets I.P.

400mg.

Ofloxacin Tablets I.P.

200mg.

Paracetamol Tablets I.P.

500mg.

Phenobarbitone Tablets I.P.

30mg.

Phenobarbitone Tablets I.P.

60mg.

Salbutamol Tablets I.P.

4mg.

Albendazole Tablets I.P.

400mg.

Mefenamic Acid Tablets I.P.

500mg.

1.2.3. LIQUIDS & DRY POWDER

Amoxycillin Dry Syrup 60ml. Bottle

125mg/5ml.

Benzyl Benzoate Application Bottle

100ml.

Cephalexin Oral Suspension (Dry) Bottle

30ml.

Chlorhexidine/Cetrimide Solution Bottle

1LTR

Glycerin Bottle

500ml.

Mixture Carminative Bottle

500ml.

Turpentine Liniment Bottle

100ml.

1.2.4. POWDER
ORS Packets WHO Formula

20.5 gm.

Purified Talc Packet

500mg.

CHAPTER 2

PRODUCTION FACILITIES
2.1. TABLET PRODUCTION
A tablet is a pharmaceutical dosage form. Tablets may be defined as the solid unit
dosage form of medicament or medicaments with or without suitable diluents and
prepared either by molding or by compression. It comprises a mixture of active
substances and excipients, usually in powder form, pressed or compacted from a
powder into a solid dose. The excipients can include diluents, binders or granulating
agents, glidants (flow aids) and lubricants to ensure efficient tabletting; disintegrants
to promote tablet break-up in the digestive tract; sweeteners or flavours to enhance
taste; and pigments to make the tablets visually attractive or aid in visual
identification of an unknown tablet. A polymer coating is often applied to make the
tablet smoother and easier to swallow, to control the release rate of the active
ingredient, to make it more resistant to the environment (extending its shelf life), or to
enhance the tablet's appearance.
The compressed tablet is the most popular dosage form in use today. About two-thirds
of all prescriptions are dispensed as solid dosage forms, and half of these are
compressed tablets. A tablet can be formulated to deliver an accurate dosage to a
specific site; it is usually taken orally, but can be administered sublingually, buccally,
rectally or intravaginally. The tablet is just one of the many forms that an oral drug
can take such as syrups, elixirs, suspensions, and emulsions. Medicinal tablets were
originally made in the shape of a disk of whatever colour their components
determined, but are now made in many shapes and colours to help distinguish
different medicines. Tablets are often stamped with symbols, letters, and numbers,
which enable them to be identified. Sizes of tablets to be swallowed range from a few
millimetres to about a centimetre.

2.1.1. TABLET COATING

Tablets are usually coated for different purposes such as masking of unpleasant taste,
protecting from moisture or light, stability enhancement, achieving targeted release or
controlled drug release rate, avoiding drug degradation in the stomach, and improving
the appearance of the tablets. Coated tablets can be classified into sugar-coated tablets
and film-coated tablets. Recently, sugar-coated tablets are not often considered
favourably during the development of new drug products and many sugar-coated
tablet products have been gradually replaced by film-coated tablets. Based on the
properties of the filming coating, film-coated tablets can be further classified as
general film-coated tablets, enteric film-coated tablets, and pH independent filmcoated tablets.
The tablets, which are used for film-coating, are called the plain tablets. The plain
tablets should possess adequate hardness allowing the tablets to withstand the stresses
during the coating process without mechanical failure such as high friability,
chipping, and capping. In addition, the plain tablets should possess the required
disintegration characteristics so that the coated tablets will meet the final product
disintegration requirements.
Nowadays, film-coating technologies have been widely used for the manufacturing of
coated tablets showing a tendency to replace the sugar-coating technology. Filmcoating materials can be classified as water soluble and alcohol soluble materials
which can also impart different functionalities to the final coating such as soluble in
gastric pHs, intestinal pHs, or independent of pHs. Film coating materials are mainly
composed of polymeric film formers, plasticizers, solubilizers, and pore-forming
agents.
The advantages of film-coating include less coating materials, less weight change,
easy to operate, high automation, good controllability, and short production time.
However, there are also a few disadvantages such as the flammable and explosive
nature of the solvents as well as the environmental pollution caused by the solvents
used. In recent years, the newly developed aqueous film coating technology with the
use of latex and pseudo-latex materials has shown great promise in replacing the
solvent-based technology. Methods for tablet coating include rotary pan coating,
fluidized bed coating, and compression coating. Commonly used methods for film-

coating are rotary pan coating and high performance pan coating. Sugar coating can
also be carried out by the rotary pan coating method.
If film-coating is performed in a sugar coating pan, several pieces of baffles should be
installed in the coating pan in order to improve the tablet flow patterns, leading to
enhanced contact between the tablets and the atomized coating liquid. The procedures
for the use of a sugar coating pan for tablet film coating are listed below.
Install 3-5 pieces of baffle in the coating pan.
The temperature of the plain tablets is controlled at 40-60C.
Spray the coating liquid onto the tablets in the coating pan which is in continuous
motion. When the required level of coating is achieved, remove the coated tablets
followed by additional drying.
During film-coating, several important aspects should be emphasized.
1) The hot air exchange efficiency should be sufficient to provide adequate heating.
2) The delivery rate of the sprayed coating liquid should be controlled and adjusted to
achieve the maximum coating efficiency and shortest processing time.
3) The atomization performance of the spray gun should be adequate and consistent.
4) The rotation speed of the coating plan should be controlled.
The above operation parameters may be different for different equipment and are to
be optimized during the process development phase. The general rule is that the
adhesive force of the atomized droplets to the plain tablets should be stronger than the
abrasion force generated between different plain tablets and between the tablets and
the pan wall so that an intact film can be formed by the coating liquid droplets being
deposited on the surface of the plain tablets.
The key factors affecting the outcomes of a film-coating operation include the
hardness of the plain tablets, the penetration and absorption of water into the tablets,
and the extent of swelling after moisture absorption which is a function of the
hydrophobicity of the tablet surface. Operation parameters including the hot air
exchange efficiency, atomized pressure, the distance between the spray gun and the

coating pan, and rate of spraying of the coating liquid will also affect the quality of
the film coating.

Figure 2.1 Tablet Manufacturing and coating Layout

Figure 2.2 Tablets Coating procedures

2.2. CAPSULE PRODUCTION
They have the facility to manufacture Beta Lactam, non Beta Lactam and gelatin
capsules.

Figure 2.3 Non-beta capsules

Figure 2.4 Beta Lactam Capsules

2.3. POWDER SECTION
2.4. LIQUIDS SECTION
2.5. PARENTERAL SECTION
2.6. REPACKING
2.7. PACKING SECTION

CHAPTER 3
CONCLUSIONS