PHARMACEUTICAL SOLUTION
Pharmaceutical Compounding
Prepared by:
Dyar Fakher Ali Muhsen Heaven Othman
Peshang Mahmood Kurdo Mahdy Frya Abdulrahim
Prepared for:
Aween Mohammed
TABLE OF CONTENT
Introduction
Preparation of Pharmaceutical Solutions
What are the advantages and disadvantages?
Types of pharmaceutical solutions and
formulation considerations for each type of
Solution
Conclusion
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Introduction
A pharmaceutical solution is a meticulously crafted mixture, characterized by its
homogeneity, consisting of active pharmaceutical ingredients (APIs) dissolved in a
chosen solvent. The formulation process is intricate, involving the careful
dissolution of APIs in a solvent, commonly water or a blend of water and alcohol.
This solution may also incorporate stabilizers or preservatives to ensure stability and
longevity. The distinctive advantage of pharmaceutical solutions lies in their
precision, offering accurate dosing and rapid absorption, contributing to uniform
drug delivery. Descriptions of pharmaceutical solutions underscore their transparent
liquid nature, which not only aids in accurate dosing but also ensures predictability
in therapeutic outcomes, emphasizing their role as a versatile and effective drug
delivery system in the realm of pharmaceutical formulations[1]. It is imperative for
a formulation scientist to possess a comprehensive understanding of various factors
to achieve successful formulation:
This includes optimizing the physical and chemical stability of the active ingredient,
judiciously incorporating specific excipients, determining optimal stability
conditions, preventing issues during up-scaling, and designing a formulation suitable
for the route of administration to overcome absorption barriers[2].
Preparation of Pharmaceutical Solutions:
The preparation process requires careful consideration of the drug's chemical
properties, solubility, stability, and the desired route of administration[3]. The
following steps are typically involved:
1. Writing out the formula either from the prescription or from an official text.
2. Calculation of the quantities required for each ingredient in the formula to produce
the final required volume.
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3. Selection of Solvents: It is important to choose the appropriate solvent. Common
solvents include water, ethanol, propylene glycol, and glycerin. The solubility of the
drug in the chosen solvent is a significant factor.
4. Dissolution of the Solid: The solid is dissolved in the chosen solvent under
controlled conditions. If more than one drug is to be dissolved , they should be
dissolved one by one in order of solubility(the least soluble first). Factors such as
temperature, agitation, and pH( in case of acids and bases) are monitored to ensure
optimal dissolution.
5. Addition of Excipients: Excipients, such as preservatives, stabilizers, and
flavoring agents, are added to enhance the stability, palatability, and shelf-life of the
solution
6. Filtration and Sterilization: Filtration and sterilization processes are used,
especially for parenteral solutions, to ensure that the solution is free of particles and
microorganisms.
7. Lastly the solution should be transferred to a suitable container, label and dispense
to the patient.
What are the advantages and disadvantages?
Pharmaceutical solutions refer to liquid formulations that include therapeutic agents
(active pharmaceutical ingredients) and excipients dissolved in a solvent system.
These solutions are commonly administered orally as homogeneous, non-sterile
dosage forms.
Advantages:
1. Elderly individuals and infants, who may struggle with swallowing medications,
find solutions beneficial for easy drug administration.
2. The dissolved therapeutic agent in the formulation improves bioavailability,
ensuring rapid absorption.
3. Additionally, the dissolved ingredients prevent precipitation in the gastrointestinal
tract.
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4. Flavors and sweeteners can be incorporated to mask the bitterness of therapeutic
agents.
Disadvantages:
1. Pharmaceutical solutions are inappropriate for chemically unstable therapeutic
ingredients in water.
2. Therapeutic agents with low solubility may pose challenges during the
formulation process, but the addition of co-solvents can improve solubility.
3. As oral dosage forms, solutions are relatively large preparations, making their
distribution challenging and costly.
Types of pharmaceutical solutions and formulation considerations
for each type of solution
Syrups is a concentrated solution of sugar in water or other aqueous solutions.
Pharmaceutical syrups are produced by mixing purified water, sweeteners, active
ingredients (API), aromas, flavors and other ingredients (thickeners).
•Spirits are alcoholic or hydroalcoholic solution of volatile substances. Generally,
the alcohol concentration of spirits is rather high, usually over 60%.
Compound spirit of cardamom B.P
Rx
Oil of cardamom 20 ml
Oil of orange 20 ml
Of cinnamon 2 ml
Oil of clove 1 ml
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•Elixirs are sweetened hydro-alcoholic (water and alcohol) liquids for oral use.
Typically, alcohol and water are used as solvents when the drug will not dissolve in
water alone Typically, an elixir is composed of ethanol (3%–23%) and water.
However, other excipients, such as glycerin, sorbitol, propylene glycol, flavoring
agents, preservatives, and syrups, may be included as well.
Phenobarbital elixir U.S.P
Rx
Phenobarbital 4g
Tr. of orange peel 30 ml
Solution of amaranth 10 ml
Alcohol 125 ml
Glycerin 450 ml
Syrup 250 ml
D.W Q.S 1000 ml
Gargles: These are aqueous hydroalcoholic solutions used to treat or prevent throat
infections and contain phenol & thymol, potassium chlorate. Ex: potassium chlorate
and phenol gargle.
Method of Preparation of Phenol Gargle Formula:
1. Phenol Glycerin – 5 ml
2. Amaranth solution – 1 ml
3. Purified water - Q.S. To 100 ml
Mouthwash:
Medicated liquid with pleasant taste and odor used to clean and deodorize the buccal
cavity, contain antibacterial agents, glycerol, and sweetening agent, flavoring agent,
coloring agent and astringent. E.g.
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Preparations of Mouthwash:
Instructions are as follows; Add a flavor, e.g., eucalyptol or menthol. Sodium
benzoate as preservative Water as vehicle Sodium saccharin and sucralose as
sweeteners. Colorants Fluoride as an antiseptic agent Detergent Method: Needed
Items:
1. Sodium Bicarbonate 10 g
2. Sodium Chloride 15 g
3. Chloroform 500 ml
4. Peppermint oil 25 ml
5. Water 1000 ml
Method of Preparation Mix sodium bicarbonate and sodium chloride in 10ml.
Add chloroform and peppermint oil. Add water to fill the required volume. Dispense
the solution. Container: Clear fluted plastic bottles with a narrow neck with a leak-
proof plastic.
Ear solutions
Ear preparation comes in a variety of forms that are used for treating infections or
softening ear wax they are available in drops and sprays, semi-solid ear preparations,
ear powders, ear washes, and ear tampons. Some of them come in a solution form like
drop, spray, and washes depending on their site of action, such as external or middle
ear, they are required to be sterile, isotonic, and have physiological pH. They can be
found in single or multi-dose containers.
for example:
Acetic acid hydrocortisone1% Ear drop solution
Hydrocortisone 1g
Acetic acid (30%) 2.4g
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Propylene glycol 96.6g
Total 100g
Is not required to be sterile because it is used in treating inflammation and infection
in the auditory canal. In contrast to preparation that is used to treat the middle ear or
those that flow to it[4].
Eye solutions
Eye drop solution is one form of eye medication that is supplied in both single and
multidose containers to be used in the eye and/or conjunctiva in the treatment of
local infection or for diagnosis purposes. it is available in both water-based and oil-
based forms. To prevent further infection, these solutions must be sterile.
Additionally, it is preferred that they have suitable osmolarity and pH levels, and
appropriate preservatives in case of multiple uses. an example of an eye solutions is
Chloramphenicol Eye Drops, Solution 0.5%
Chloramphenicol 0.5g
Borax 0.3g
Boric acid 1.5g
Thiomersal 0.002g
Water for injection 97.7g
Total 100g
Which can be used in treating a local infection[4].
Nasal solutions
Nasal solutions in spray or drop form can be used to eliminate infections and
congestions in the nose furthermore they are used to gain systematic effects. they are
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available in single or multidose containers with suitable pH, viscosity, isotonicity,
and excipients. An example of nasal solutions for decongestion is
Xylometazoline Nasal Drops/Spray, Solution 0.025 %
Xylometazoline hydrochloride 0.025g
Benzalkonium chloride 0.01g
Disodium edetate 0.1g
Disodium phosphate dodecahydrate 0.1g
Sodium chloride 0.8g
Sodium dihydrogen phosphate dihydrate 0.15g
Water, purified Q.S 100 mL
Gel preparations:
a gel is a semisolid system consisting of a network of solid particles dispersed
throughout a liquid phase. Gels are typically designed to be applied topically to the
skin or mucous membranes for various therapeutic purposes, such as delivering
medications, providing localized relief, or facilitating wound healing, a gel is a
semisolid system consisting of a network of solid particles dispersed throughout a
liquid phase. Gels are typically designed to be applied topically to the skin or mucous
membranes for various therapeutic purposes, such as delivering medications,
providing localized relief, or facilitating wound healing,
One common example of a gel used in pharmacy is "Diclofenac Gel." It is a topical
anti-inflammatory medication applied to the skin to reduce pain and inflammation
in conditions such as arthritis or muscle sprains.\
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Diclofenac gel formulation:
Diclofenac sodium: 1.0 g (1% w/w)
Carbomer: 2.0 g
Isopropyl alcohol: 40.0 g
Propylene glycol: 20.0 g
Purified water: 35.0 ml
Sodium hydroxide: q.s. to adjust pH
Preservatives: as needed
Conclusion:
pharmaceutical solutions serve as vital dosage forms in the industry, offering
advantages like rapid absorption and precise dosing. Despite their benefits,
challenges such as stability and taste masking exist. Specialized types, from
ophthalmic to oral preparations like syrups and elixirs, require distinct formulation
considerations. While solutions streamline administration, their unique requirements
emphasize the ongoing need for research to enhance efficacy and patient
compliance.
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References
[1] J. F. Marriott, Pharmaceutical compounding and dispensing. Pharmaceutical Press, 2010.
[2] L. Jorgensen, S. Hostrup, E. H. Moeller, and H. Grohganz, “Recent trends in stabilising peptides
and proteins in pharmaceutical formulation - Considerations in the choice of excipients,” Expert
Opinion on Drug Delivery, vol. 6, no. 11. pp. 1219–1230, Nov. 2009. doi:
10.1517/17425240903199143.
[3] C. Langley Dawn Belcher Langley, “Pharmaceutical Compounding and Dispensing.” [Online].
Available: www.fasttrackpharmacy.com
[4] Y. Bouwman-Boer V’, I. Fenton-May, and P. Le Brun Editors, “Practical Pharmaceutics An
International Guideline for the Preparation, Care and Use of Medicinal Products.”
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