Semi-solid dosage forms

(Ointments pastes creams gels)

Ointments (unguents)
They are semisolid preparations intended for external application. Ointments intended for application to the eye are called ophthalmic ointments & must be sterile.

Ointments may be: (Types of ointments)

1) Medicated: used in treatment of skin diseases. Ex: sulfur ointment and zinc oxide ointment. 2) Non-medicated (Ointment bases): used as vehicles in the preparation of medicated ointments or used as emollients or protective. Ex: white ointment.

Ointment bases:
1-Hydrocarbon bases (oleaginous bases) Characters: 1) Water-free (anhydrous). 2) Have greasy effect (hydrophpbic). 3) Non water removable. 4) Aqueous preparations are incorporated only with small amount with difficulty. 5) Dont dry out upon aging. Uses: emoilent. Types according to physical state: 1) Semisolid: e.g. petrolatum (petrolatum jelly, Vaseline) Simple ointment (white): composed of white petrolatum (95%) and bees wax (5%). Simple ointment (yellow): composed of yellow petrolatum (95%) and bees wax (5%). 2) Solid: e.g. hard parrafin. 3) Liquid: Mineral oils e.g. paraffin.

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2- Absorption bases They are used in case of aqueous drugs e.g. gentamycin sulphate. Types: 1. Those that permit the incorporation of aqueous solution, resulting in the formation of water in oil emulsions e.g. hydrophilic petrolatum & anhydrous lanolin. 2. Those that are already W/O emulsions that permit the incorporation of small additional quantities of aqueous solutions e.g. lanoline & cold cream. Characters: 1) Have greasy effect. 2) Non water removable (non washable). 3) Can absorb aqueous solutions. 4) Used as emolients. Examples: Hydrophilic petrolatum: It has the ability to absorb water, resulting in the formation of W/O emulsions. Anhydrous lanolin: It can absorb twice its weight of water & give w/o emulsion. Lanolin: Its w/o emulsion containing 25-30% water & permit incorporation of additional quantities of water. Cold cream: it is w/o emulsion. 3- Emulsifying bases (water-removable or water-washable) These bases contain O/W emulsifying agents & easily washed from the skin & called water-washable bases. They may be diluted with water or with aqueous solutions They have the ability to absorb serous discharges & exudates. Hydrophilic ointment; It contains Sodium lauryl sulfate SLS (O/W emulsifying agent). Stearyl alcohol & white petrolatum (the oily phase). Propylene glycol & water (the aqueous phase).

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4) Water-soluble bases They are greaseless, soluble in water and water washable. Aqueous drugs are not incorporated in water-soluble bases. Only non aqueous drugs are incorporated. Example: Polyethylene glycol ointment Polyethylene glycols are polymers of ethylene oxide & water. PEG may present as liquid, semi solid or solid according to the molecular weight.

Pastes
They are semisolid preparations intended for external application to the skin.

They differ from ointments in that:

1) They contain a larger percentage of solid material so they are thicker & stiffer than ointments. 2) Less greasy. 3) More absorptive.

Zinc Oxide paste:

Prepared from mixing 25% of each ZnO & starch with petrolatum used as astringent & for protection.

Levigation: means the decrease of particle size of drugs to be easily

incorporated in the base (vehicle). In ointments levigation occurs by using liquid paraffin while in pastes levigation occurs by using petrolatum.

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Creams
They are viscous liquid or semisolid emulsions of either O/W type or W/O type. Examples: cold cream and vanishing cream.

Item - Emulsion - Oil content - Water content - Emulgent - Appearance - Time of use - Humectants

Cold cream w/o emulsion type 80 % 20 % Bees wax Shining Night No humectants are incorporated

Vanishing cream o/w emulsion type 20 % 80 % Alkali soap Not shining Day Humectants are incorporated

Liquid dosage forms Mixtures

Definition:
They are liquid pharmaceutical preparations, the vehicle is aqueous & the medicaments may be in solution or suspension. They should be freshly prepared.

The main element of the mixture:

1) The active ingredients. 2) Vehicle e.g. distilled water, aromatic water, infusion & decoction. 3) Additives (Sweeting, coloring, flavoring & suspending agents).

Types of mixtures:
1- Simple mixtures They contain one or more active ingredients completely soluble in the vehivle e.g. NaCl & potassium citrate.

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2- Mixtures containing insoluble diffusible solids They contain insoluble substances in water. These substances are light. They are easily diffused just only by shaking the bottle & give a uniform dose so there is no need for suspending agent. Examples: light MgCO3, CaCO3, MgSO4, Mg trisilicate. 3- Mixtures containing insoluble indiffusible solids These substances dont remain evenly distributed in the vehicle for a sufficient time after shaking to ensure a uniform dose. Example: Creta prepareta. We need suspending agents to increase the viscosity of the medium & decrease the rate of sedimentation and allow uniform doses. Examples of suspending agents: Acacia and tragacanth (powdered or mucilage). 4- Mixtures containing slightly soluble liquid Slightly soluble liquids [e.g.creosote] dont diffuse & will be separated so we need suspending agents. These liquids are easily soluble in alcohol & glycerin and when these solvents present in a sufficient amount, they can dissolve the insoluble creosote & the mixture will be a Simple mixture. 5- Mixtures containing precipitate forming liquid A) Resinous tinctures These are alcoholic solutions of resins extracted from crude drugs e.g. tincture myrrh & tincture benzoin. When the tinctures are diluted with water, the resins are precipitated in form of colloidal state or clot so we need suspending agents.

B) Spirits These are alcoholic solutions of volatile liquids which are sparingly soluble in water. On dilution with water, it will produce a fine precipitate. No suspending agent is required & only shaking is required.

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6- Effervescent Mixtures They contain a freshly prepared salt by combining citric acid & sodium carbonate or bicarbonate at the time of dispensing, producing a mixture charged with CO2. Example: potion reviera mixture It is composed of citric acid and sodium bicarbonate. It is used as antacid and antiemetic.

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Solutions
Solution:
It is a homogenous one phase system consists of solvent & solute.

The solute (dispersed phase):

It is the component which is dispersed as small molecules (e.g. sugar) or ions (e.g. NaCl) in the solvent.

The solvent (dispersion phase or dispersion medium):

It is the phase in which the dispersion occurs.

Advantages of solutions:
1) Easy to swallow for pediatrics & geriatrics. 2) They provide a rapid absorption rate & so the therapeutic response is faster.
Solutions have faster absorption rate than tablets because drugs in solutions have large surface area and dont have to be dissoluted.

3) The drug has a uniform distribution. 4) Drugs in solutions are less irritating to stomach than drugs in solid dosage forms due to rapid dilution by gastric contents.

Disadvantages of solutions:
1) 2) 3) 4) Difficult to transport & store because liquids are bulky. The stability of drugs in aqueous solutions is poor. There is a probability for growth of microorganisms. Accurate dosage depends on the ability of the patient to use a spoon or dropper. 5) The taste of a drug is usually unpleasant & the colour may be unattractive.

Formulation of solutions
A. Aqueous solution
Water is widely used as solvent.

Advantages of water:
Non expensive. Non toxic, tasteless and odorless. Compatible with gastric fluids. Able to dissolve wide range of drugs. -7Dr-Mustafa Shahin 1) 2) 3) 4)

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Disadvantages of water:
1) Instability of some drugs (e.g. ester, glycols) in water. 2) Growth of microorganisms.

Types of waters:
1. Potable water (Tap or drinking water): 100 ml of official potable water contains not more than 100 mg of residue after evaporation to dryness (at 105C). USES: 1) For washing & extraction of crude drugs. 2) Not used in pharmaceutical preparations due to increased contamination and presence of dissolved salts that destroys the active ingredients. 2. Purified water: 100 ml of official purified water contains not more than 1 mg of residue after evaporation to dryness (at 105c). It is obtained from potable water by: 1) Distillation and 2) Deionization by ion exchange resins (there is no heat so the cost is low). USES: It is used as solvent for internal and external pharmaceutical preparations 3. Water for injection (WFI): It is pyrogen-free distilled water, sterilized immediately after collection. It is used for parenteral preparations.

B. Non aqueous solutions

Any solvent other than water could be used if the drug is insoluble or unstable in aqueous systems. Grisoefulvin is insoluble in water. Benzylpenicillin is unstable in water.

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Types of non-aqueous solvents

Water-miscible solvents.

Water-immiscible solvents.

Example:

Example: Vegetable oil e.g. sesame oil, olive oil, maize oil, cotton seed oil & linseed oil. Mineral oil e.g. liquid paraffin.

Liquid macrogol = PEG

Propylene glycol Ethyl alcohol Glycerol

Synthetic oil e.g. ethyl ether, isopropyl myristate.

Examples of non-aqueous solvents:

1. Fixed oils: They are non volatile e.g. almond oil, castor oil and cotton seed oil. They are used mainly for IM injections examples: Oily phenol injection BP: Water is not used due to caustic effect of phenol but oil masks this effect. Calciferol injection: Oil is used to give depot action.
N.B: Oils may have pleasant or unpleasant taste Oils with pleasant taste are used as solvents for vitamins A and D. Oils with unpleasant taste are used in emulsions (O/W emulsion type).

2. Alcohols (ethyl alcohol): Widely used as solvents for external preparations as it is rapidly evaporated after application giving cooling effect on the skin. Examples of preparations in which alcohols are used: Topically as in pastes and liniments. Orally (co solvent) as in syrups and elixirs (at concentration less than 15%). 3. Liquid paraffin: It has unpleasant taste so rarely used in internal preparation. It is not degraded in the body and converted to toxic materials.

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4. Ethyl ether: It is used in extracion of crude drugs. Not used for oral preparations. 5. Dimethyl sukfoxide (DMSO): Highly polar compound aids in the penetration of drugs through the skin and used as penetration enhancer for transdermal systems. 6. Miscellaneous solvents: Such as isopropyl myristate and isopropyl palmitate. They have lower viscosity and lower greasy effect than fixed oils so they are used for external use especially in cosmetics.

Additives for solutions:

1. Preservatives They act against microbial contamination. For oral administration: Chloroform 0.25% Benzoic acid 0.1% For external use: Parahydroxyl benzoate (parabens) Chlorocresol 0.1% Chlorobutol 0.5% 2. Buffers They are materials, when dissolved in a solvent, will enable it to resist any change in PH when a small amount of acid or alkali is added. Characters of buffers: 1) Compatible with GIT fluids and other excipients. 2) Low toxicity. Examples of buffer: For internal administration: phosphate, citrate & carbonate. For external use: borate. 3. Flavoring (sweetening) agents: Flavoring agents are added to solutions for oral administration to mask the unpleasant taste (e.g. sucrose).

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4. Coloring agents: Colors are added to solution for external use to facilitate the identification or to improve the attractiveness. 5. Additives for adjustment of isotonicity We add NaCl to increase the tonicity of hypotonic solution. Hypertonic solutions should be well diluted before taking orally. 6. Stabilizers They are added to protect drugs against oxidation and degradation. Examples of antioxidants: Ascorbic acid (Vitamin C): non toxic and palatable. Sodium metabisuphite.

1) Oral solutions e.g. simple mixture.

2) Nasal solutions. 3) Ophthalmic solutions e.g. boric acid eye lotion. 4) Otic solutions e.g. sodium bicarbonate ear drops. 5) Parenteral solutions. 6) Rectal solutions. 7) Vaginal solutions. 8) Dermal (topical) solutions.

1) Aromatic waters. 2) Syrups. 3) Elixirs.

4) Sirits.
5) Linimints. 6) Extractives.

Aromatic waters
Definition:
They are clear, aqueous solutions, saturated with volatile oils or other aromatic substances.

USES:
1) Flavoring agents. 2) Some of them have therapeutic effect. - 11 Dr-Mustafa Shahin

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Methods for preparation of aromatic water:

1. Distillation method Boil the plant with water in a suitable still and then collect the distillate. Examples: Orange flower water NF & Strong rose water NF 2. Solution method V.O. + H2O shaking for 15 min. Stand for 12 hours to ensure complete saturation then filtration through wetted filter paper. 3. Alternative solution method V.O. + Talc + H2O shaking for 10 min then filter. The first portion of the filtrate is re-filtrated to obtain a clear sol. N.B: Talk powder is used as a filter aid & a distributing agent so increasing the surface area and dissolution rate. 4. Dilution method Alcoholic solution of aromatic substances + water + talc. The mixture is agitated & filtered. Aromatic water is then prepared by dilution with water.

5. The use of surface active agent (SAA or surfactant). By dissolving the aromatic substances in solution of surfactant (e.g. tween 20), so greater amount of aromatic substances can be dissolved. The aromatic water is then prepared by dilution with water.

Stability of aromatic water:

1) 2) 3) 4) Support growth of mould and microorganisms. High temperature causes loss of aroma. Low temperature causes separation of the aromatic substances The addition of electrolytes causes salting out of the aromatic substances. 5) Should be stored in light-resistant bottles or dark bottles to Avoid auto-oxidation which can be catalyzed by light and traces of metals.

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Injections
They are sterile pyrogen-free preparations intended to be administered parentally.

Added substances:
1. Adjustment of isotonicity: Hypotonic solutions may cause haemolysis. Hypertonic solutions may cause shrinkage (plasmolysis). So we asjust the tonicity by NaCl (0.9% sol of NaCl is isotonic) 2. Adjustment of PH: Very acid or alkaline solutions injected by subcutaneous or intramuscular routes, will cause pain & tissue damage. If injected by IV route, it may cause phlebitis. PH is adjusted by using suitable buffer e.g. phosphate buffer. PH is adjusted in order to: 1) Increase the stability. 2) Increase therapeutic activity. 3) Prevent irritation & tissue damage. 3. Adjustment of specific gravity: It is important in spinal anaesthesia. 4. Stabilizers: a. Antioxidants (reducing agents): * For aqueous solutions: - Sodium Metabisulphate, Sodium sulphite & ascorbic acid. * For oily solutions: - butylated hydroxy anisole (BHA). - butylated hydroxy toluene (BHT). - Alpha tocopherol. - Propyl gallate. b. Suitable chelating agents: Examples: Sodium edetate, calcium edetate, citric acid and tartaric acid. c. Method of removing oxygen: Use of water for injections free from dissolved gas. - 13 Dr-Mustafa Shahin Mobile: 01007513538

 Replacement of the air in the container with an inert gas e.g. Nitrogen & carbon dioxide. d. Other methods of stabilization stored at suitable conditions & at suitable PH. 5. Preservative: For aqueous solutions: Phenol, chlorocresol, orthocresol, phenyl mercuric salts and benzyl alcohol. For oily solutions: phenol, chlorocresol & orthocresol. Preservatives: It is necessary to add a preservative to the product to decrease the probability of product contamination. Reasons for contamination: 1) Raw materials. 2) Equipments. 3) Consumer use. Ideal characters of preservatives: 1- Effective against wide range of M.O 2- Stable for the shelf life of the formulation. 3- Non toxic 4- Non sensitizing 5- Relatively free of taste and odor. 6- Compatible with ingredients. Examples of preservatives commonly used in solution: 1- Alcohols Ethanol: in conc more than 10%. Propylene glycol: in conc 15-30%. It is non volatile like ethanol. 2- Acids Benzoic acid and Sorbic acid Only the non ionized form is effective, and therefore its use is restricted to preparations with a pH below 4.5. 3- Esters (Parabens) Parabens are esters of p-hydroxybenzoic acid and include the methyl, ethyl, Propyl and butyl derivatives.

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 These compounds are widely used in pharmaceutical products and are effective and stable over a pH range of 4 to 8. Frequently two esters are used in combination in the same preparation to achieve a higher total concentration and the mixture will be effective against a wide range of M.O. 4- Quaternary Ammonium compounds This class of compounds has an optimum activity over a pH range of 4 to 10 and are stable in room temperature. Because of the cationic nature of this class, it is incompatible with many anionic compounds. Benzalkonium chloride is the most famous member in this class.

Enemas
They are aqueous solution or suspensions intended for rectal administration.

Types of enemas:
1. Evacuation enemas Used to evacuate the bowel to treat constipation e.g. soft soap enema & MgSO4 enema. The volume of evacuation enema is up to 2 liters. Need warming before use. 2. Retention enemas Give local or systemic effects. The volume not more than 100 ml. Need not warming before use.

Uses:
a. Local effect Emollient; to relieve local irritation e.g. starch enema. Anthelmintic e.g. turpentine enema. Radio-opaque; for x-ray examination of lower bowel e.g. BaSO4

b. Systemic effect Sedative e.g. thiopental sodium enema. Nutritive e.g. nutrient enema which contains vitamins, carbohydrate & minerals.

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Douches
Aqueous solutions applied into part or into one of the body cavity to act as cleansing or antiseptic agent. E.g. Vaginal douche, eye douche and nasal douche.

Gargles
They are aqueous solutions intended to be used after diluted with warm water. Uses: astringent, antiseptic, anaesthetic and soothing effects.

Mouthwashes
They are solutions with pleasant taste and odor intended to washout the mouth. Uses: Astringent, antiseptic, refreshing effect and deodorant.

Lotions
They are liquid preparations intended for external application. They may be either: 1) Solutions (e.g. boric acid eye lotion) or 2) Contain dispersed solid or liquid by using suspending or dispersing agents. Lotions are applied to the skin for protection where they leave a thin protective coat after drying on the skin. Lotions should be labeled by shake before use. Examples: Calamine lotion: It contains 8% of each zinc & calamine with glycerin & Ca(OH)2 solution. Calamine is composed of zinc oxide with a small amount of ferric oxide which gives calamine its pink color.

Ophthalmic solutions (eye drops)

Sterile isotonic solution containing saline drops and drug. Uses: 1) Treatment of eye diseases. 2) If they do not have medicament, they will be used as lubricating and tear replacement solution (artificial tears).

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Types of containers: 1) Single dose containers: need not preservatives. 2) Multiple dose containers: contain preservatives.

Otic solutions
Usually contain solvents (water or glycerin) Uses of glycerin: 1) Viscous so allows drug to remain in ear for long time. 2) Hygroscopic so removes moisture from surrounding tissues so reduces swelling.

Nasal solutions
Intranasal drug administration offers: (advantages) 1) Rapid absorption into systemic circulation. 2) Safe & acceptable alternative to parenteral route. Aim of administration: Nasal congestant used in treatment of rhinitis of common cold. Side effects: prolonged (frequent) use lead to chronic edema so they are used for short periods not longer than 3-5 days.

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1. Syrups Def.: nearly saturated aqueous solutions of sugar such as sucrose in water, with or without medicinal or flavoring ingredients. Syrups may be: 1. Simple sugar only in water. 2. Flavored contain aromatic or pleasantly flavored substance. 3. Medicated contain some added medicinal substances. Syrups are used as a sweetening agent or a vehicle (to mask bitter & salty drugs). Explain? It is important that the concentration of sucrose approach but not quite reach the saturated point. In diluted Solution (20-30%) sucrose provides an excellent nutrient for moulds, yeast and other microorganisms. In concenterated Solution (65% or more) retard the growth of microorganisms, however, a saturated solution may lead to crystallization of a part of the sucrose under condition of changing temperature.

Components of syrups:
1) Sugars (sucrose). 2) Preservatives, flavorings and colorants. 3) Solvents, solubilizing agents, thickeners and stabilizers.

Inversion of sucrose:
Inversion of sucrose occurs by acid or heat.

Properties of invert sucrose:

1) 2) 3) 4) Easily fermented.
Retard oxidation of substances.

Sweeter than sucrose. Degradation of levulose results in brown discoloration, this called caramilization.

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Methods of preparation of syrups:

1- Solution with the aid of heat: Sucrose + water heating till solution is formed. Heat-stable components are added to the hot syrup. Heat-labile components & volatile substance are added after cooling.
Disadvantages: 1) Excessive heating may cause inversion of sucrose. 2) Surups cant be sterilized by autoclaving without caramelization.

Uses: For thermostable components. To prepare syrups quickly. 2- Solution by agitation "without the aid of heat" Sucrose + water shaking till solution is formed. Used in case of thermo-labile substances & to avoid the inversion of sucrose and caramilization. Disadvantages: time consuming.

Preservation of syrups
USP suggests that syrups should be kept at a temperature not above 25C. Otherwise a preservative must be added, if the concentration of sucrose is less than 85% w/v, as glycerin, methyl paraben, sodium benzoate & benzoic acid. The amount of preservative is proportional to the amount of the free water. Storage: in well tight containers, and stored in a cool drak place.

Artificial Syrups:
1. Non-nutritive syrups: These are sugar-free vehicles which are used as substitutes to be administered to patients suffering from diabetes mellitus.

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Components: 1) Water: vehicle. 2) Preservatives. 3) Saccharine sodium or sodium cyclamate: artificial sweetening agents. 4) Sodium carboxymethyl cellulose: viscosity builder.
Cyclamate sodium & saccharin sodium. They could produce cancer in animals. They have bitter after taste. Aspartame (200 times sweeter than sucrose) is the widely used as an artificial sugar nowadays.

2. Sorbitol based syrups: Components: 1) Sorbitol. 2) Preservatives if sorbitol is less than 60% w/w. 3) Saccharine sodium or sodium cyclamate: artificial sweetening agents.

Elixirs
They are clear, sweetened hydro alcoholic solutions intended for oral administration. They are usually flavored to increase their palatability.

Elixirs differ from syrups in that:

1) 2) 3) 4) Less sweet. Less viscous. Less effective in masking the taste of medicinal substances. Presence of alcohol.

Advantages of elixirs:
1) Able to maintain water-soluble & alcohol-soluble components in solution. 2) More stable than syrups. 3) Easily prepared.

Added substances:
1) Sweeteners; sucrose, sucrose syrup, sorbitol, glycerin or artificial sweetener as saccharin. - 20 Dr-Mustafa Shahin Mobile: 01007513538

 IF Elixir contains a high alcoholic content, we use an artificial sweetener as saccharin because: Small amounts are used due to its great sweetness. Sucrose is slightly soluble in alcohol & if used, it will be precipitated. 2) Flavoring materials. 3) Elixirs containing over 10% alcohol need not preservatives.

Preparation of elixirs:
1) Water-soluble substances are dissolved in water & alcoholic-soluble substances are dissolved in alcohol. 2) The aqueous solution is added to the alcoholic solution to decrease the separation of alcohol-soluble components. 3) Talc powder may be used as a filter aid to adsorb excessive amounts of oils & help in their removal from the solution.

Spirits
They are alcoholic or hydroalcoholic solutions of volatile oils or volatile substances. The solubility of volatile substances in alcohol is greater than that in water. The alcoholic content of spirit is greater than that of elixir.
Spirits are preparations of high alcoholic strength (Alcohol concentration usually over 60%), so they must be stored in tight, light resistant containers, and in a cool place to prevent evaporation of alcohol or the active principle. Spirits become turbid when diluted by aqueous solutions or liquids of low alcoholic content.

Preparation of spirits:
1) Simple solution 2) Solution with maceration 3) Chemical reaction

Uses of spirits:
1) Flavoring agents. 2) May be taken orally, applied externally or used by inhalation.

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Liniments
They are solutions or mixtures of various substances in oil, alcoholic solution of soaps, or emulsions. They are intended for external application and should be red labeled. Applied with friction and rubbing of the affected skin. The oil or soap provides ease of application and massage. Alcoholic types are used for rubefaciant, counterirritant & penetrating effects. Oily liniments are milder in action as they can't penetrate the skin easily & they have protective function.

Collodions
They are clear viscous solutions composed of pyroxylin (4% w/v) dissolved in a 3:1 mixture of ether & alcohol with or without added substances. Collodions form a protective film after solvent evaporation & used to hold edges of incised wound together & increase wound healing. Flexible collodion: Prepared by adding 2% camphor & 3% castor oil to collodion to give flexible product & more comfortable use. Salicylic acid collodion: Its 10% solution of salicylic acid in flexible collodion used as keratolytic for removal of corns from toes.

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