Herbal excipients which are easily available, lower cost and are noncarcinogenic, which can be used to replace synthetic excipients which are carcinogenic.
Natural colorants obtained from various insects and plants, which gives harmless dying agents which can be used in food industry as well as textile industry.
2. • Excipients are defined as the substance used as a medium for
giving a medicament.
• The specific application of natural polysaccharide polymers in
pharmaceutical formulations include to aid in the
• processing of the drug delivery system during its
manufacture,
• protect, support or enhance stability,
• bioavailability or patient acceptability,
• assist in product identification, or enhance any other
attribute of the overall safety, effectiveness or delivery of the
drug during storage or use.
3. • Pharmaceutical excipients
• Pharmaceutical excipients may be described as in-active ingredients
that are combining with medicinally active compounds to formulate
the medicines.
• The substances, which is an inactive compound is referred as an
excipient (Additives, Adjuncts).
• Excipients combine with API and helps in improving the functioning
and effectiveness of the medicinally active compounds.
• Excipients makes drug product better significantly.
• The function of excipients is to enhance the stability, absorption,
bulk and durability of active compounds.
• Excipients are very important for the product variability.
• In any pharmaceutical formulation, the amount of excipients is
probably 3 times more than therapeutically active compound.
4. • Excipient plays a great role in the performance of the API and to
support the safety & efficacy.
• Excipients are generally used as
• diluents,
• binders,
• surfactants,
• preservatives
• sweeteners in common dosage forms like syrups, tablets and
capsules.
• The toxicity, adverse effects and approval from regulatory
authorities causes difficulties with synthetic excipients.
• Due to these problems with synthetic excipients researchers show
more attraction towards the use of herbal excipients in
formulations.
• In present days, herbal excipients are replacing the use of
synthetic excipients in pharmaceutical industry, because of less
toxicity, easily availability and low expenses.
5. CLASSIFICATION OF EXCIPIENTS
Excipients are commonly classified according to their
application and function in the drug products:
• Binders
• Diluents
• Lubricants
• Glidants
• Disintegrants
• Polishing Film formers and
coatings agents
• Plasticizers
• Coloring agents
• Suspending agents
• Preservatives
• antioxidants
• Flavoring agents
• Sweeteners
• Taste improving agents
• Printing inks
• Dispersing agents
• Gums
6. • Advantages of Herbal Excipients
• Natural excipients, all are obtained from the natural resources.
Hence, they are safe and biodegradable.
• They do not affect the environment.
• Chemically, all of these natural/herbal excipients are
carbohydrates in nature. Hence natural excipients are non-toxic
compounds.
• Natural excipients are cost effective and their manufacturing cost
is less than synthetic excipients.
• Natural excipients are produced from a natural source and hence,
they do not show any adverse effects or side effect on the
human beings.
• Natural excipients are easily available from different natural
resources.
• Some of natural drugs may have more than one activity, like they
acts as excipients as well as they have some therapeutic activity
also.
7. • Disadvantages of Herbal Excipients
• During manufacturing, natural excipients come in contact with
external environment and hence, there are many possibilities of
microbial contamination.
• Natural excipients production depends on environmental
conditions, regions and climates. Hence, the amount of different
natural excipients and percentage of constituents also varies in
different conditions.
• Herbal excipients have possibilities of heavy metal contamination.
9. COLORANTS
• Colorants or coloring agents are mainly used to impart a
distinctive appearance to the pharmaceutical dosage forms.
• We can also say that the colorants are the cosmetics for the
pharmaceutical preparations, because the aesthetic appearance
of dosage forms can be enhanced by using suitable colorants.
• The main categories of dosage form that are colored are:
• tablets (either the core itself or the coating.)
• hard or soft gelatin capsules: (the capsule shell or coated beads)
• oral liquids and topical creams
• The elegance and eye appeal of a colored product is valuable,
especially for children whom it is often used to treat with syrups,
tablets, or capsules, to avoid injections and allow treatment at
home.
10. Purpose of using Colorants :
• Increases acceptability
• Unattractive medication can be made more acceptable to the
patient by the use of color, and color can also be used to make a
preparation more uniform when an ingredient in the formulation
has itself a variable appearance from batch to batch.
• Many patients rely on color to recognize the prescribed drug and
proper dosage.
• These attributes assist in improving patient compliance.
• It is believed that brightly colored tonics, cherry red children’s cough
mixtures and flesh‐tinted powders and ointments are more likely to
be used because they are attractive.
11. • For identification
• It helps to identify a product in its manufacturing and distribution
stages.
• Colors may be used for identifying similar‐looking products
within a product line, or in cases where products of similar
appearance exist in the lines of different manufacturers.
• The use of different colors for different strengths of the same drug
can also help eliminate errors.
• Stability purpose
• Some of the insoluble colors or pigments have the additional
benefit when used in tablet coatings or gelatin shells of providing
useful opacity, which can contribute to the stability of
light‐sensitive active materials in the tablet or capsule
formulation.
• Pigments such as the iron oxides, titanium dioxide, and some of
the aluminum lakes are especially useful for this purpose.
13. Ideal properties of a colorant :
• Nontoxic and have no physiological activity.
• Free from harmful impurities
• Is a definite chemical compound because then only its coloring power will
be reliable, its assay should be practicable and easier.
• Its Tinctorial (coloring) power should be high so that only small quantities
are required
• Unaffected by light, tropical temperatures, hydrolysis and
micro‐organisms and, therefore, be stable on storage.
• Unaffected by oxidizing or reducing agents and pH changes.
• Compatible with medicaments and not interfere with them.
• Easily solubility in water is desirable in most cases but some oil‐soluble
and spirit‐ soluble colors are necessary.
• Does not interfere with the tests and assays to which the preparations
containing it.
• Should not be adsorbed on to suspended matter.
• Free from objectionable taste and odour.
• Readily available and inexpensive
14. Source (Common Name) Compound Color shade
ANTHRAQUINONE
Dactylopius coccus (Cochineal) Carminic
acid
Red
Rubia tinctorum (Madder) Alizarin Red
Coccus laccae (Lac) Laccaic acid Red
Kermes ilicis (Shield louse) Kermisic
acid
Scarlet
NAPTHOQUINONES
Lawsonia alba (Henna) Lawsone Orange
Juglans nigra (Black walnut) Juglone Brown
Lithospermum erythrorhizon
(Shikone)
Shikonin Violet