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Herbal Drug Formulation PDF
Herbal Drug Formulation PDF
ABSTRACT
In recent years there is a spurt in the interest regarding survival of Ayurvedic forms of medication. In the global
perspective, there is a shift towards the use of medicine of herbal origin, as the dangers and the shortcoming of
modern medicine have started getting more apparent, majority of Ayurvedic formulation are prepared from herbs. It
is the cardinal responsibility of the regulatory authorities to ensure that the consumers get the medication, which
guaranteed the purity, safety, potency and efficacy. As a result of this Standardization arise for maintaining a good
coordination among the quality of raw herb material, in process materials and in final product. Present study was
carried out to standardize different types of formulations using pharmaceutical excipients.
Key words: Herbal medicine, Excipients, herbal extracts, Tablets, Gels.
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rendering it unfit, hence in order to stabilize the API Vegetable source: - Starch, Peppermint, Turmeric,
excipients are added which aid in maintaining the Guar gum, Arginates, Acacia etc.
stability of the product and ensures that API retains Mineral source: - Calcium phosphate, Silica, Talc,
its stability for a considerable period of time thus Calamine, Asbestos, Kaolin, Paraffin, etc.
improving the shelf life of dosage formulation. Synthetic: - Boric acid, Saccharin, Lactic acid,
Bulk up the formulation in case of potent drug Polyethylene glycols, Polysorbates, Povidone etc.
for assisting in formulation of an accurate dosage The following tables gives a classification of various
form. excipients used in pharmaceutical dosage forms:
Improve patient acceptance. (table no 1,2,3)
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Binders and Impart cohesive qualities to Improves free flow Acacia, Gelatin, Starch paste,
Adhesives powdered material. qualities by formulation Polyvinyl pyrrolidone, Glucose,
of granules to desired Carboxymethyl cellulose,
hardness and size. Povidone.
Lubricants Reduce inter-particular friction, Interpose a film of low Talc, Stearic acid, Magnesium
prevent adhesion of tablet shear strength that stearate, Calcium stearate,
material to the surface of dies interface between the Polyethylene glycol,
and punches facilitate easy tabletting mass and die Surfactants, vegetable oil.
ejection of tablet from die wall
cavity and improve the rate of
flow tablet granulation
Glidants Improve flow characteristics of Added in dry state prior Colloidal Silicone dioxide
powder mixture. compression, it reduces (Carbosil), Asbestos free
friction between starch, Corn starch.
particles.
Disintegrants Facilitate breakup or Function by drawing Starches, Clays, Cellulose,
disintegration after water into the tablet, Cross linked polymers,
administration swelling it and causing Modified starches such as
the tablet to burst Primogel and Explotab,
apart. Veegum HV.
Superdisintegrants Improved disintegrant efficacy Crosscarmalose, Cross
resulting in decreased use Povidone, Sodium starch
levels when compared to glycolate.
traditional disintegrants
Flavors Limited to chewable tablets/ Mask unpleasant taste Spray dried and other flavors,
tablets intended to dissolve in syrups etc.
mouth.
Sorbents Moisture proofing Limits the fluid sorbing, Silica gel, activated carbon, clay
taking up of liquid or Etc
gas either by adsorption
or absorption in dry
state.
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Co solvents Increase the solubility of Co-solvent system works by Ethanol, Sorbitol, Glycerin,
solute in solvents. reducing the interfacial Propylene glycol etc.
tension between
predominantly aqueous
solutions and hydrophobic
solutes.
Buffers Maintain pH of the Act by binding hydrogen Phosphate buffers, Acetate buffers,
formulation. ions in acids and donating Citric acid Phosphate buffers etc
hydrogen ions in bases
Antimicrobial Prevent microbial growth Bacteriostatic action Benzyl alcohol, Butyl paraben,
preservatives. in formulations. Phenol, Thiomersal etc.
Antioxidants Control oxidation. Act by getting preferentially Ascorbic acid, Sodium bisulphate,
oxidized or by blocking an Thiourea, Butyl Hydroxy Toluene
oxidative chain reaction. (BHT), Tocopherols.etc
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Wetting Aid wetting and Act by reducing interfacial Sodium Lauryl Sulphate (SLS),
agents dispersion of tension between solids and Tween 80, Spans, Lecithins etc.
hydrophobic active liquids in suspensions.
pharmaceutical
ingredients.
Antifoaming Discourage formation of Lowers surface tension and Simethicone, Organic phosphates,
agents stable foam. cohesive binding of liquid Alcohols, Paraffin oils, Sterates
phase. and glycols.
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continues to receive attention as scientists are in need medicines or dosage forms. Formulation
of plants particularly of ethno botanical significance development is the development of bioactive stable
for a complete range of biological activities, which and optimal dosage form for a specific administration
ranges from antibiotic to anticancerus. Several plants route. This involves the use of excipients which
and herbs species used traditionally have potential ensures that the therapeutic performance, the safety
antimicrobial and antiviral properties and this has parameters and the stability of the active drug
raised the optimism of scientists about the future of substance is not compromised (Oradifiya, 2009).
phyto antimicrobial agent. For most herbs, the
specific ingredients that cause a therapeutic effect is HERBAL MEDICINES FORMULATION
not known, whole herbs contain many ingredients A herbal medicine formulation is any medicinal
and they likely work together to produce the desired product exclusively containing one or more herbs or
medicinal effect. These components work together to processed herb in specified quantities as the active
produce therapeutic effects, lessen the incidence of ingredients to provide specific therapeutic,
side effects and enhance effectiveness, synergistic nutritional, cosmetic and other benefits. These
action and reduce toxicity. Most herbal medicines are formulations are obtained by subjecting herbal
well tolerated by the patient with fewer unintended substances to various treatments such as drying,
consequences than pharmaceutical drugs. Herbs extraction, distillation, expression, fractionation,
typically have fewer side effects and may be safer to purification, concentration, fermentation etc.,
use over a long period of time. Herbal medicines tend standardizing and then incorporating the appropriate
to be more effective for long standing health excipients. Extraction of active ingredients from
complaints that do not respond well to conventional plants began in the early 19th century when chemical
medicines, they have lower costs and are readily analysis became available, later chemists began
available and accessible compared to conventional making their own version of plant compounds and
medicines. Formulation studies involve developing a over the time, the use of herbal medicines declined in
preparation of the drug which is both stable and favour of synthetic drugs. However, recent interest in
acceptable to the patient. Herbal formulation means a herbal medicines due to increased and advanced
dosage form consisting of one or more herbs or research, safety, availability and lower cost has led to
processed herbs in specified quantities to provide the need to produce more formulations to meet
specific nutritional, cosmetic and/or other benefits demand. Herbal formulations come in different
meant for use to diagnose, treat, mitigate diseases of forms, these include decoctions, capsules, tablets,
human beings or animals and/or alter the structure or creams, gels, ointments, tinctures, suppositories and
physiology of human beings or animals16. even some novel forms such as extended release,
sustained release and microencapsulating dosage
DOSAGE FORM forms (Musthaba et al., 2010). The most common
Dosage form is a mixture of active drug components dosage forms of herbal preparations are liquids
and non drug components or excipients. There are derived from macerations, infusions and decoctions,
several forms of dosage forms, which can generally with the associated problems of large dose volumes,
be classified as solid dosage form, liquid dosage form difficult packaging and poor stability. Solid
and semisolid dosage form. Drugs are usually not preparations such as capsules and tablets on the other
administered as pure chemical substances alone but hand often have higher stability and are easier to
are almost always given as formulated preparations. standardize which adds to an increase in their
These can vary from relatively simple solutions to therapeutic acceptance, efficacy and product value.
complex drug delivery systems through the use of Large scale production of herbal medicines which is
appropriate additives or excipients in the formulation as a result of commercialization of herbal medicines
(Aulton, 2007). Excipients provide various requires that scientists and manufacturers maintain
pharmaceutical functions, these include the quality and safety of these herbs, as such
solubilisation, suspending, thickening, emulsifying, assurance of quality, safety and efficacy medicinal
modifying dissolution, improving the compactibility plants and herbal products have become very
and flavoring drug substances to form various important.
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antioxidants and stabilizers (BP,1988). The wanted for longer term storage. To qualify as an
interactions between the liquid vehicle and the alcoholic tincture, the extract should have an ethanol
colloidal particles are either physical or covalent, the percentage of at least 40–60%. In herbal medicine,
vehicle is continuous and interacts with the colloidal alcoholic tinctures are made with various
particles within three dimensional network that is concentrations of ethanol with 25% being the most
formed between adjacent particles. The vehicle may common. Other concentrations include 45% and
be aqueous, hydro alcoholic, alcohol based or non 90%. Herbal tinctures are not always made using
aqueous. The colloidal particles may be dispersed ethanol as the solvent, though this is most commonly
solids or dispersed polymers (USP, 2007). the case. Other solvents include vinegar, glycerol,
ether and propylene glycol, not all of which can be
OINTMENTS used for internal consumption. Ethanol has the
Ointments are greasy, semi-solid preparations, often advantage of being an excellent solvent for both
anhydrous and containing dissolved or dispersed acidic and basic constituents.
medicaments intended for external application to the
skin or mucous membranes. Herbal Ointments are SUPPOSITORIES
used for topical applications and they are made by A suppository is a drug delivery system that is
mixing powdered drugs are to be incorporated for inserted into the rectum (rectal suppository), vagina
local application should depend on the condition of (vaginal suppository or pessary) or urethra (urethral
the patient's skin, the biological effect desired, and suppository), where it dissolves or melts. They are
the pharmaceutical compatibility of the ingredients used to deliver both systemically-acting and locally-
with each other and the base. Ointment bases are acting medications. The principle is that the
classified into four major groups, these are suppository is inserted as a solid, and will dissolve or
hydrocarbon bases, absorption bases, water melt inside the body to deliver the medicine pseudo
removable or emulsion bases and water soluble received by the many blood vessels that follow the
bases. larger intestine. Alternative dosage forms for the
rectal and/or vaginal route are tablets, capsules,
CREAMS ointments and enemas. Generally suppositories
Creams are semi-solid dosage forms containing one consist of a vehicle in which the drug is incorporated
or more drug substances dispersed in a suitable base and in some cases additives are coformulated. A
that is mixtures of oil and water. They are divided pharmaceutical pessary is used as a very effective
into two types: oil-in-water creams which are means of delivery of pharmaceutical substances
composed of small droplets of oil dispersed in a easily absorbed through the skin of the vagina or
continuous water phase, and water-in-oil creams rectum, or intended to have action in the locality, for
which are composed of small droplets of water example against inflammation or infection, or on the
dispersed in a continuous oily phase. A cream is a uterus. There are two main classes of vehicles or
topical preparation usually for application to the skin suppository bases, the fatty base and the water
and also application to mucous membranes such as soluble or water miscible bases.
those of the rectum or vagina.
CONCLUSION
TINCTURES Oral herbal dosage forms from herbal extract shows
A tincture is typically an alcoholic/water extract of good elegance & palatability. Liquid dosage forms
plant or animal material or solution of such or of a like Liquid Oral & Suspension having good stability
low volatility substance such as iodine and on storage. Thus it can be concluded that these oral
mercurochrome. It is used when plants have active herbal dosage forms could be suitable dosage forms
chemicals that are not soluble in water and/or when for Herbal plant extracts for commercial purpose.
larger quantities is prepared for convenience and
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