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WAJEEHA ISHTIYAQ
B.Sc, Pharm-D PU,
M.Phil (scholar) Pharmaceutics PU.
R.Ph (pb).
Freshly and Recently Prepared
• The direction, given under the heading Extemporaneous Preparation,
that a preparation must be freshly prepared indicates that it must be
made not more than 24 hours before it is issued for use.
• The direction that a preparation should be recently prepared indicates
that deterioration is likely if the preparation is stored for longer than
about 4 weeks at 15°C -25°C.
(Ref. B.P. 2009)
SOLUTION
Definition:
A solution is a homogenous liquid preparation that contains one or
more dissolved medicaments.
• No need for shaking when dispensing the solution.
TYPES OF SOLUTIONS
• Oral: Local action in other body
• Mixtures cavities:
• Elixirs • Douches
• Linctuses • Enemas
• Gargles • Liniments
• Mixtures are seldom formulated for long life because they are mainly
prescribed for acute conditions such as cough, , indigestion, diarrhea
and constipation for which a short period of treatment is often
adequate.
• Contain multiple ingredients
• Less stable –Some have short life because deterioration is likely if they
are stored longer than a few weeks even under room temperature.
• Freshly prepared
• Stating Expiry:
Mostly a month
Preferable only 15 days supply should be issued
Expiry is based on the date of issue
Last date of use may be two days after the last dose time particularly in case of
few mixtures such as gentian mixture, alkaline with phenobarbitone B.P.C.
STATEMENTS USED FOR EXPIRY
CASE #1:
Rx
Choral Hydrate Mixture B.P.C. 100ml
For a child of one year
Dose: 2.5ml at night
Pharmacist Work up (PW):
Rule 1: Calculate No. of doses in 100ml:
100/2.5=40
This is 40 days supply
Rule 2:
Making dose equal to 5ml by diluting 2.5ml dose to 5ml. The total volume to
be dispensed against this order is 40 * 5ml = 200ml ( double dilution is
needed here)
Rule 3:
Choose diluents advised by BPC is 1 part simple syrup diluted with 4 parts
water
CALCULATIONS:
Calculate doses as for batches of two weeks supply( as not more than 2 week supply of a
diluted mixture may be issued at one time).
5x14= 70ml
70+70+ 60= 200ml
Ask patient to return for further supplies of 70 and 60 ml at 14 days intervals.
Label and dispense
Counsel the patient for dose, precautions, revisit time and storage
Store in a dark cupboard
GENERAL FORMULATION OF MIXTURES
1. VEHICLE:
• The vehicle is the medium in which ingredients of medicine are dissolved or dispersed.
• WATER
Either potable water freshly drawn direct from the public supply and suitable for drinking
or
Freshly boiled and cooled Purified Water
should be used if the public supply is from a local storage tank or if the potable water is
unsuitable for a particular preparation.
• AN AROMATIC WATER
Flavoring, therapeutic agent, preservative action
Diluted from concentrates
Nowadays concentrates are directly use in the official formulae
• A MEDICAMENT
Where vehicle has therapeutic activity
oCompound Gentian Infusion, to stimulate appetite
oOrange Peel Infusion as carminative
AROMATIC WATERS
Aromatic Concentrated Preparation Use
Concentrated Anise Water Flavor, Carminative, Mild expectorant
Concentrated Camphor Water Flavor
Carminative
Mild expectorant
Concentrated Caraway Water Flavor
Carminative
Mild expectorant
Concentrated Cinnamon Water Flavor
Carminative
Mild expectorant
Concentrated Peppermint Water Flavor
Carminative
Weak preservative
ADJUNCTS USED IN MIXTURES
CHEMICAL STABLIZERS
Only antioxidents and reducing agents are represented.
Ascorbic Acid (0.1%) for Ferrous Sulphate Mixtures
Sod. Metabisulphite (0.1%) for Sod. Salicylate Mixture
COLOURS (coloured medicaments)
FLAVOURS
Aromatic waters- popularly anise water
Syrup/glycerol- for sweetening pediatric preparations.
Liquorice Liquid extract- for masking taste of saline ingredients such as NH4 salts and
alkali iodide in cough mixtures.
Lemon Spirit- to cover taste of alkaline citrate
Orange Syrup and Compound Orange Spirit- to mask metallic and astringent taste of iron
salts in children mixtures.
PRESERVATIVES
• CHLOROFORM (0.25%v/v)
– esp. for vegetable extract
• BENZOIC ACID (0.1%w/v)
– Effective in acid preparation of pH 5or below but not in neutral
or alkaline soln.
– Slightly and slowly soluble in water
– Stock solution prepared in water:
• 5% Benzoic Acid
• 75% propylene glycol
• PEPPERMINT WATER ( antimicrobial activity)
• PEPPERMINT OIL
– preserved with 0.25% Chloroform
1-MIXTURES WITH LIQUIDS ONLY
• Chemical Stabilizers:
– Solvents are stabilizers
– Additional stability is sometime required
• Citric acid for Neomycin to low pH to 4-5
• Di sod.edetate in antibiotic to sequester heavy metals
• Flavoring Agents:
– Sweetening agents
• Sucrose, glycerol, invert syrup, saccharin sod
– Fruits flavors
– Liquorice and aromatic vehicles are less used
• Preservatives:
Alcohol inhibitory to mould growth and fermentation.
Syrup in large amounts is inhibitory to many organisms.
Additional preservatives include.
Chloroform water double strength
Spirit
Benzoic acids
ADJUNCTS IN ELIXIRS
COLORING AGENT FRUIT FLAVOURS PRESERVATIVES
Solution Elixir Flavor Elixir In Elixirs
Amaranth Paracetamol Blackcurrent Chloral Syrup, Paeds Alcohol
(Magenta Streptomycin Syrup Propylene glycol
Glycerol
Red) Conc. Raspberry Paracetamol Elixir, High osmolarity prep
with invert syrup Paeds
Comp. Ephedrine
Isoniazid
Lemon Spirit Ephedrine Elixir
Tartarazine Neomycin With syrup and Chloroform, Double Strength
(Saffron) Phenobarbitone invert syrup Chloroform, Spirit
Comp. Orange Phenobarbitone Elixir Chloroform
Spirit with
Piperazine Citrate glycerol
Green S and Benzoic Acid
Tartarazine Citric Acid and Bitter taste of
(Green) Sodium Citrate barbiturates Methyl PHBA
EXAMPLE
Add to alcohol
Methyl
Thymol Menthol Cineole Pumilio Pine oil
Salicylate
Talc /Kaolin
Water base
Labels:
•Store in a Cool Place
•Shake the Bottle
•Not to be Swallowed in Large Amounts
THROAT SPRAYS
• Containing antibiotics and used for conditions such as pharyngitis and
tonsillitis and mostly intended to medicate lungs.
• Contain propylene glycol or glycerol, reducing agent(sodium
metabisulphate) , preservatives(antibacterial, antifungal e.g., chlorobutol)
• Dispensed in atomiser
- special type (nabulizer) deeper parts
- scent-spray type atomiser for superficial
parts( upper part of respiratory tract)
• Official preparations is Adrenaline and atropine spray, compound, B.P.C.
bronchial relaxant used to relieve asthma.
• Container: Use a fluted narrow mouthed, light resistant,
screw capped bottle. Well filled container
EXPIRY DATES
Internal Preparations Date
Diluted Mixtures, elixirs and linctuses 14 days from the date of issue
Recently prepared undiluted 1 month from the date of issue
preparations
Freshly Prepared undiluted Preparations Two days after the date on which the
preparation should have been
completely used according to label
instructions