1. Course Title : Pharmaceutical Chemistry
sessional and Field Visit
Presented By : Sagar Kumar dutta
Student I.D- 111815
2. Kemiko, one of the fastest growing Pharmaceuticals company, has been
going through manufacturing and marketing of Pharmaceuticals, herbal,
Food supplement and veterinary products.
Since its inception in 1988, the company has always been committed to
serve the mankind with the best products and services.
They have got highly qualified and experience professionals in all
departments including Research and Development , Production, Quality
Assurance, Quality Control.
The plant of this company is equipped with modern facilities, including
clean zones for production and HPLC, atomic Absorption
Spectrophotometer etc. for Q.A.
The company, with all these facilities, strictly follows the WHO-guided
Good manufacturing Practices (GMP)
3. To gather practical knowledge of Pharmaceutical product
production.
To see the raw materials they used in pharmaceutical
product production.
To acquire practical knowledge about the technical
information in Pharmaceutical product production.
To acquire knowledge about testing process of making
good quality Pharmaceutical product.
To know about the mechanical process of Pharmaceutical
product production.
4. What is drug?
Drug is any article whether natural or
synthetic having therapeutic and
medicinal properties and used in the
diagnosis, cure, mitigation, treatment
or prevention of disease in man and
other animals.
What is medicine?
Medicine is the dosage form of the
drug. Drug is the active ingredient of
the medicine.
Medicine= Drug + excipient
Gels
Solutions
Ointments
Oils
Creams
Foams
Sprays
5. Solid medicine.
Semi solid medicine.
Liquid medicine.
Semi Solids: Semi solids are different types like cream, ointment, jelly etc.
Kemiko Pharmaceutical generally produce two types of semi-solid. They are
1. Cream- Oil & Water mixture
Two types i) Water in oil e.g. cold cream & ii) Oil in water e.g. vanishing cream
2. Ointment – Only Oil
Types of medicine
(According to the doses form)
6. Ointment
Ointments are soft semisolid preparation meant for
external application to the skin or mucous membrane .
They usually contain medicament, which is either dissolved
or suspended in the base.
What is Ointments?
Medicinal
application of the
Ointment
Ointment bases
Preparation of the
Ointments
Storage and
dispensing
Ointments
It should be chemically and physically stable.
It should be smooth and free from grittyness.
It should melt or soften at body temperature and easily applied.
The base should be non-irritating and should have no therapeutic action.
The medicament should be finely divided and uniformly distributed throughout the
base.
Classification of
Ointment
7. Classification of Ointment
Ointments may
Classified as follows:
According to their
therapeutics properties.
According to their
therapeutic uses.
Epidermi
c
• Theses ointment are intended to
produce their action on the
surface of the skin.
Endoderm
ic
• These ointments are intended
to release medicaments that
penetrate into the skin.
Diadermic
• These ointments are to release
the medicaments that pass
through the skin and produce
systemic effects.
1. Antibiotic Ointment:
Used to kill the micro-organisms
2. Anti-fungal Ointment: Used to kill the fungi.
3. Anti-inflammatory Ointment:
To relieve inflammatory
4. Antipruritic Ointment:
To relieve itching.
5. Protectant Ointment:
Protect the skin from moisture , air sun ray etc.
And there are also several types Ointment are
found.
Ointments
What is Ointments?
Classification of
Ointment
Medicinal
application of the
Ointment
Ointment bases
Preparation of the
Ointments
Storage and
dispensing
8. Medicinal application of the Ointment
Ointments are used topically for several purposes,
e.g., as protectants, antiseptics, emollients,
antipruritic, kerotolytics, and astringents.
In the case of a protective ointment, it serves to
protect the skin against moisture, air, sun rays and
other external factors.
It is necessary that the ointment neither penetrates
the human skin barriers nor facilitates the
absorption of substances through this
Ointments
What is Ointments?
Classification of
Ointment
Medicinal
application of the
Ointment
Ointment bases
Preparation of the
Ointments
Preparation of the
Ointments
Storage and
dispensing
9. An antiseptic ointment is used to destroy or inhibit the
growth of bacteria. Frequently bacterial infections are
deeply seated; a base which has the capacity to either
penetrate or dissolve and release the medication effectively
is therefore desired.
Ointments used for their emollient effect should be easy to
apply, be non-greasy and effectively penetrate the skin
Different types of chemical are used for preparing the
ointment such as:
Salicylic acid , titanium dioxide , petrolatum, zinc oxide coal
etc.
Medicinal application of the Ointment
Ointments
What is Ointments?
Classification of
Ointment
Medicinal
application of the
Ointment
Ointment bases
Preparation of the
Ointments
Storage and
dispensing
10. Ointment base
There are five
(5) classes or
types of
ointment
bases which
are
differentiated
on the basis of
their physical
composition.
These are:
1.
Oleagin
ous
bases.
2.
Absorption
bases.
3. Water in
oil
emulsion
bases.
4. Oil in
water
emulsion
bases.
5. Water
soluble or
water
miscible
bases.
Ointments
What is Ointments?
Classification of
Ointment
Medicinal
application of the
Ointment
Ointment bases
Preparation of the
Ointments
Storage and
dispensing
11. Ointment base
Ointments
What is Ointments?
Classification of
Ointment
Medicinal application of
the Ointment
Ointment bases
Oleaginous O.B.
Absorption O.B.
W/O emulsion O.B.
O/W emulsion O.B.
Choice of the O.B.
Water miscible O.B.
Preparation of the
Ointments
These bases are fats, fixed oils, hydrocarbon or silicones.
They are anhydrous, greasy, non-washable does not absorb water and
occlusive (form a film on skin so it increases the skin hydration by
reducing the rate of loss of surface water.
They should not be applied to inffected skin.
they are used as protectants, emollients , vehicles for hydrolyzable
drugs.
Example: White Petrolatum, White Ointment
Storage and dispensing
12. Ointment base
Oleaginous base + w/o surfactant.
Anhydrous but hydrophilic ointment bases, they can absorb several
times their weight of water to form water-in-oil emulsion.
They are non-washable, not water soluble
They used as protectants, emollients (+/-), vehicles for aqueous
solutions, solids, and non-hydrolyzable drugs.
Example: Hydrophilic Petrolatum, Anhydrous Lanolin, Aquabas,
Aquaphor, Polysorb
Ointments
What is Ointments?
Classification of
Ointment
Medicinal application of
the Ointment
Ointment bases
Oleaginous O.B.
Absorption O.B.
W/O emulsion O.B.
O/W emulsion O.B.
Choice of the O.B.
Water miscible O.B.
Preparation of the
Ointments
Storage and dispensing
13. Ointment base
These are anhydrous, hydrophilic, absorbs water and non water removable,
with low thermal conductivity and occlusive.
They have the same properties as the absorption basees.
They are used as emollients, cleansing creams, vehicles for solid, liquid, or
non-hydrolyzable drugs .
Examples: Cold Cream type, Hydrous Lanolin, Rose Water Ointment,
Hydrocream, Eucerin, Nivea .
Ointments
What is Ointments?
Classification of
Ointment
Medicinal application of
the Ointment
Oleaginous O.B.
Absorption O.B.
W/O emulsion O.B.
O/W emulsion O.B.
Water miscible O.B.
Choice of the O.B.
Ideal O.B.
Preparation of the
Ointments
Storage and dispensing
14. Ointment base
These bases are anhydrous, water soluble, absorb water and water
washable.
They are either carbowaxes Polyethylene Glycols (PEGs) or hydrated
gums (bentonite, gelatin, cellulose derivatives).
They are used as drug vehicles.
Examples: PEG Ointment, Polybase™
Water miscible
O.B.
These bases are anhydrous, water soluble, absorb water and water washable.
They are either carbowaxes Polyethylene Glycols (PEGs) or hydrated gums
(bentonite, gelatin, cellulose derivatives).
They are used as drug vehicles.
Examples: PEG Ointment, Polybase™
Ointments
What is Ointments?
Classification of
Ointment
Medicinal application of
the Ointment
Oleaginous O.B.
Absorption O.B.
W/O emulsion O.B.
Water miscible O.B.
Preparation of the
Ointments
Storage and
dispensing
O/W emulsion O.B.
15. PRESERVATIVES
Some bases , although, resist microbial attack but because of
their high water content, it require an anti microbial
preservative.
Commonly used preservative include:
Methyl hydroxy benzoate
Propyl hydroxy benzoate
Chorocresol
Benzoic acid
Phenyl mercuric nitrate
Ointments
What is Ointments?
Classification of
Ointment
Medicinal application of
the Ointment
Preparation of the
Ointments
Storage and
dispensing
Preservatives
Choice of the O.B.
16. Selection of the Appropriate Base Based on:
1. Desired release rate.
2. Desirability for enhancement of percutaneous absorption.
3. Advisability of occlusion.
4. Short-term or long-term stability.
5. Influence of drug on consistency or other features of ointment base.
6. Patient factor - dry or weeping (oozing) skin.
1. Dermatological factors.
a ) Absorption and penetration
Only the ointment base penetrates deep into the tissues of the skin.
Substance which are soluble both in oil and water are most readily absorbed.
Water soluble substances are more readily absorbed from water soluble bases.
b) Effect on skin Function:
Greasy bases interfere with normal skin functions.
O/W emulsion bases and other water miscible produce a cooling effect rather
than heating effect and mix readily with skin secretions.
c) Miscibility with skin secretions and serum .
d)Compatibility with skin secretion
e) Ease of application and removal .
This point are dermatological factors for selection of an ideal ointment base.
Ointments
What is Ointments?
Classification of
Ointment
Medicinal application of
the Ointment
Preservatives
Preparation of the
Ointments
Storage and
dispensing
17. 2. Pharmaceutical Factors :
a) Stability
Fats and oils obtained from animal and vegetable sources are liable to
undergo oxidation unless they are suitably preserved.
Emulsions prepared with wool fat are liable to surface discoloration
b) Solvent properties
Most of the ointment base are finely powdered and distributed uniformly
throughout the base
A base consisting of a mixture of hard paraffin, soft paraffin's bees wax
is used .
c) Emulsifying Properties
d) Consistency
This point are dermatological factors for selection of an ideal
ointment base.
Ointments
What is Ointments?
Classification of
Ointment
Medicinal application of
the Ointment
Preservatives
Choice of the O.B.
Preparation of the
Ointments
Storage and
dispensing
18. Preparation of the Ointment
Water phase prepare in
container (A) at temperature of
700C
Flow diagram of general preparation of
ointments Oil phase prepare in container
(B) at temperature of 700C
vacuum vacuum
Min vessel (mixing), stirring at 8000C
for 50 min ( high speed =1500rpm
and low=45 rpm)
Milky appearance
Congealing for 1 hr
Ointments
What is Ointments?
Classification of
Ointment
Medicinal application of
the Ointment
Preservatives
Choice of the O.B.
Preparation of
the Ointments
Storage and
dispensing
19. Preparation of the Ointment
Transferring and weighing yield
QA Approval
Filling and packing
Two mixing techniques are frequently used in making ointment
1. Fusion, in which ingredients are melted together and stirred to
ensure homogeneity .
2. Trituration , in which finely-subdivided insoluble medicaments are
evenly distributed by grinding with a small amount of the base or
one of its ingredients followed by dilution with gradually increasing
amounts of the base
fusion
Trituration
Ointments
What is Ointments?
Medicinal application of
the Ointment
Classification of
Ointment
Choice of the O.B.
Preservatives
Preparation of the
Ointments
Storage and
dispensing
1. Fusion,
2. Trituration
20. Packing, labeling and Storage
Packing:
The ointment are generally packed in ointment jars or collapsible tubes.
Amber coloured glass jar are used for light-sensitive preparations.
While filling the ointment jar ointment jar care must be taken to avoid the
entrainment of air.
Collapsible tubes made up of tin are also used for filling the ointments.
Storage:
The ointment should be stored in well closed containers and in a cool place.
High temperatures are likely to soften or melt the base during storage there
rendering the preparation unfit for use.
Labeling:
Ointment jar should be labeled with good quality of self-adhesive labels.
Self –adhesive strip labels are used because the ordinary gummed labels do
not stick well to the surface of the container.
21. Stability of Ointment
The ointment should remain stable from the time of preparation to the
time when whole of it is consumed.
On long storage the ointments lead to microbial growth therefore a
suitable preservative must be added to inhibit the growth.
Ingredients like wool fat and its derivatives lead to oxidation.so
antioxidant may be added to protect the active ingredients from
oxidation.
Humectants such as glycerin, propylene glycol and sorbitol may be
added to prevent the loss of moisture from preparation.
Ointment must be stored at an optimum temperature otherwise
separation of phase may take place.
22. Advantages and Disadvantages:
Advantages
Handling of ointments is easier than bulky liquid dosage forms.
They are chemically more stable than liquid dosage forms.
They facilitate application of the directly to the effected body part and
avoid exposure of other parts to the drug.
They prolong the contact time between the drug and effected area .
The bioavailability of drugs administered as ointments is more since it
prevents passage through liver.
Disadvantages:
They are bulkier than solid dosage forms.
When applications of an exact quantity of ointment to the affected area is
required, it is difficult to ascertain the same .
They are less stable than solid dosage form