Soft dosage forms include ointments, creams, gels, liniments, pastes, suppositories, and patches.

Ointments

Ointment (Unguentum, Ung.)– a soft dosage form intended for application to the skin, wounds and mucous membranes and consisting of a base and evenly distributed in it medicinal substances.

Based on the type of dispersed systems, ointments are divided into homogeneous (alloys, solutions), suspension, emulsion and combined. Depending on the consistency properties, ointments are divided into ointments themselves, creams, gels, liniments, and pastes.

Gels– ointments with a viscous consistency, capable of maintaining their shape and possessing elasticity and plasticity. Based on the type of dispersed systems, hydrophilic and hydrophobic gels are distinguished.

Creams– ointments of soft consistency, which are emulsions such as oil in water or water in oil.

Liniments- ointment in the form of a viscous liquid.

Pastes– ointments of dense consistency, the content of powdery substances in which exceeds 25%.

Traditionally, Vaseline is usually used as ointment bases. (Vaselinum) is a product of oil refining. Vaseline is almost not absorbed from the surface of the skin, so it is used to prepare ointments that act on the surface of the skin.

Waxes are also used as a base. Lanolin ( Lanolinum) – product sebaceous glands sheep leather Lanolin can be water-based ( hydricum) and anhydrous ( anhydricum). It penetrates easily through the skin and is well preserved. Beeswax and spermaceti are also used. Beeswax– thickener for ointments, creams. Spermaceti is a waxy substance obtained by cooling the liquid animal fat (spermaceti oil) of the sperm whale, as well as some other cetaceans. Animal fats are also used, for example pork fat (Adeps suillus depuratus). Pork fat is well absorbed through the skin. It deteriorates quickly, so ointments prepared on this basis are unsuitable for long-term storage. Other Basics – Vaseline oil (Oleum Vaselini), paraffin wax (Paraffinum durum), fat-like substances and synthetic substances.

According to the method of application, ointments can be for external use, nasal, rectal.

A simple ointment consists of one medicinal and one formative substance.

Recipe example 31. Prescribe 30.0 g of official zinc ointment. Prescribe for application to affected areas of the skin.

A comment. Usually the ointment is produced in tubes. The prescription indicates the total amount of ointment in the tube. After the word “give” (D.) there is no need to write that you need to give out one tube of ointment. In the same line, after the abbreviated word “designate” (S.), the signature is written.

Recipe example 32. Prescribe 1.0 g of 5% Acyclovir ointment. Prescribe externally. The drug is applied 5 times a day in a thin layer to the affected and adjacent areas of the skin for 5 days.

Recipe example 33. Prescribe 10.0 g of “Oksolin” ointment containing 0.25%halene. Prescribe lubricating the nasal mucosa 2-3 times a day every day for 25 days.

A complex ointment includes more than two ingredients.

Recipe example 34. Prescribe 2.5 g of dex-gentamicin ophthalmic ointment containing gentamicin + dexamstasone. Prescribe a strip of ointment 1 cm long to place in the conjunctival cavity 2-3 times a day.

Expanded copybook is used for writing in prescriptions main ointments. Main prescriptions, including ointments, are drawn up at the discretion of the doctor. If the prescription for the ointment was drawn up by a doctor, and it is prepared in production department pharmacies, the prescription must list all the ingredients: the medicinal substance (one or more) and the ointment base, indicating their quantity in units of weight. The recipe ends with a prescription M.f. unguentum (Misce ut Jiat unguentum – mix to make an ointment). If the ointment base is not specified in the recipe for the main ointment, the ointment is prepared with Vaseline. For eye ointments use a base consisting of 10 parts anhydrous lanolin and 90 parts petroleum jelly.

Recipe example 35. Prescribe 50.0 g of ointment containing 10% dermatol for application to the wound surface.

Rice. 1.1.

Based on their ability to interact with water, ointments are divided into: the following types: fatty ointment, hydrogels, oil-in-water creams, water-in-oil creams, liquid creams.

Soft dosage forms accompany a person from birth. The first meeting with them occurs in infancy, when the mother smears delicate skin baby with baby cream. From now on, we become inseparable from a variety of ointments, gels and pastes.

Soft dosage forms, the classification and characteristics of which will be presented below, are used in dermatology, ophthalmology, surgery, gynecology and other areas of medicine. They are very popular among doctors of various specialties due to their ease of application, ease of preparation and long shelf life. The cosmetics industry is also hard to imagine without all kinds of creams and ointments.

Ointments

It is best to start the story about soft dosage forms with ointments, since this association is the first to come to mind for the average citizen. Ointments are medications used for external use that contain less than a quarter of the dry matter of the total amount of the drug. They are obtained by mixing medicinal substances with bases that have a characteristic consistency.

Soft dosage forms on modern ointment bases (vaseline, lanolin, lard, wax, paraffin oil, etc.) are produced both on an industrial scale and in piece form, unique recipes. When choosing a base, the nature of the application is taken into account, healing effect, which must be achieved, as well as the ability of the material to dissolve drugs. For example, petroleum jelly only coats the skin, but lanolin is also absorbed into it.

Since ointments are used mainly for treatment dermatological diseases, then in their production they focus on local action. The doctor can prescribe these drugs in an abbreviated or expanded form. The abbreviated form is used for finished medicines, as well as when the ointment contains only one medicinal component and is mixed with petroleum jelly.

Creams

It is impossible to imagine soft dosage forms without creams. The cream is a dispersed system that contains two or more components. Such a system, while maintaining the necessary thermal characteristics, retains its characteristic consistency - less viscous than cream.

An oil-in-water emulsion can contain up to 90% water and is designed to moisturize the skin. If the “water in oil” composition is used, then the components are taken in approximately equal proportions. This cream is necessary to soften and nourish the skin. The composition may include fats, waxes, mineral oils, silicones, alcohols and other substances.

The mixture for making the cream is selected in accordance with its purpose. It can have a warming or, conversely, cooling effect, relieve inflammation or promote the healing of a skin defect. To prescribe the cream, abbreviated recipes are used, while the base and amount of water are never indicated, leaving this issue at the discretion of the pharmacist.

Gels

Gel is a soft dosage form that can be used not only externally, but also subcutaneously and even orally. It has a jelly-like consistency and is usually colorless or transparent. On this moment This is the most common and popular form of release of medicinal substances.

There are hydrophilic and hydrophobic gels. They are obtained by combining water, polymer powder (usually acid) and a neutralizer (soda, ammonia, carbonate, etc.). After thorough mixing, the mixture thickens and a gel is obtained. The viscosity of the resulting substance is measured in poises or centipoises.

The variety and popularity of gels are explained by the fact that their characteristics are close to the hydrogen index of the skin, they are quick and easy to prepare, they are evenly distributed and do not clog pores. In addition, almost any medicinal substance can be added to the gel.

Pastes

Paste is one of the types of ointment that contains more powdery substances (about 65%) and, as a result, more thick consistency. Thanks to this property, it remains on the skin for a long time and absorbs excess fluid, which makes it indispensable for achieving an anti-inflammatory effect.

In most cases, to achieve the desired consistency of the paste, neutral substances such as zinc powder, talc or starch are added to it. Recipes for pastes are written only in expanded form. An exception is made only for factory-produced finished drugs. As a rule, after indicating the main ingredients and base in the required proportions, they write: “Mix to make a paste.” Official pastes are written out, indicating tradename.

Liniments

When listing soft dosage forms in pharmacology, we also mean liquid ointments or liniments. Essentially, these are thick or jelly-like liquids that melt at a temperature of 37 degrees, so they must be rubbed into the skin of the damaged area. This may include any gels or pastes that have characteristic features.

Liniments have a short shelf life, so they are most often prepared directly in the pharmacy. For preparation, use a liquid base (sunflower, olive, linseed or vaseline oil). After specifying all the ingredients and their proportions, the recipe must indicate: “Mix to make liniment.” This is important, since ointment, paste and liniment may have the same composition.

Suppositories

Soft dosage forms in pharmaceutical production are also represented by suppositories. They, like liniments, melt at body temperature, but at the same time normal conditions capable of maintaining solid form. Cocoa butter or alloys of paraffin and other inert substances are used as the basis for this type of medicine.

There are rectal and vaginal suppositories. The first ones, as a rule, have a bullet or cone shape and weigh on average up to three grams. Vaginal suppositories can be in the form of balls, ellipses or have a flat shape (pessaries). They also weigh three to four grams.

Rectal suppositories are used both to treat local processes in the rectum and for general effects on the body, because good blood supply to this part of the digestive canal allows substances to be quickly absorbed from the mucous membrane and have a systemic effect.

When prescribing suppositories with simple composition, the active ingredient and its quantity are indicated. In case of prescribing suppositories with complex composition, written only commercial name and number of units of medication.

Gelatin capsules

If a pediatrician or gerontologist needs to prescribe a medicine to a patient in a soft dosage form, the prescription begins with the word: “capsules.” The shell in such medicines consists of edible gelatin. It is necessary so that the active substance reaches the place of application unharmed. For example, not all medications tolerate the acidic environment of the stomach well, so they need to be protected from such influences while maintaining the necessary properties.

Depending on the method of application, the capsules are:

• oral;
• vaginal;
• rectal.

They can have different contents: powders, granules, capsules, pellets, tablets, ointments or even live bacteria.

Plasters

Patches close the list of soft dosage forms. The recipes and their characteristics are quite simple. The patches are attached to the skin in order to have a local or general effect on the body. At a temperature of 20 degrees, this medicine is solid and is a mixture of rubber, fats, oils, antioxidants and active ingredients.

Some patches do not carry a therapeutic load, but are used to fix the edges of a wound, tighten the skin in a certain direction (in traumatology, cosmetology, dermatology) or to hold bandages and bandages in place.

Since the majority medicinal plasters have official names and are produced in a factory, then when writing a prescription they use an abbreviated form, indicating only the trade name and size.

Soap

Cosmetic and medical soaps are slightly different in composition. The latter is obtained after heating alkali and fat, while glycerin and other fatty acid. In order to catalyze the reaction, sodium hydroxide or potassium hydroxide is used.

When water is added, the soap begins to foam and mechanically cleanses the skin. If the composition contains sedatives or disinfectants, then in addition to the main effect, it relieves inflammation, dries out rashes or disinfects.

The official medical soap is White powder odorless, which can dissolve in water or alcohol. There is also “green soap” - a translucent brown or greenish mass with a faint odor.

6.Soft dosage forms

Soft dosage forms, their characteristics.

Soft dosage forms include ointments, liniments, pastes, suppositories, and patches.

Ointment- a soft dosage form for external use, having a viscous consistency, capable of forming a continuous film on the surface of the skin and mucous membranes.

Ointments consist of a base and one or more medicinal substances, evenly distributed in it, and auxiliary substances.

Ointments should have a soft consistency that would ensure ease of application to the skin and mucous membranes and would facilitate the formation of an even, continuous film on the surface. To achieve the required therapeutic effect, the medicinal substances in the ointment must be dispersed as much as possible and evenly distributed throughout its entire mass. The composition of the ointment should not change during use and storage. The concentration of medicinal substances in the ointment and its weight must correspond to what is prescribed in the prescription.

Eye ointments In addition, they must be sterile, without mechanical inclusions. They should not irritate or damage the mucous membrane.

Depending on the location of application, ointments are divided into the following types:

Dermatological;

Nasal ointments;

Ophthalmic;

Dental;

Vaginal;

Rectal;

Urethral.

Based on the nature of their action, ointments are divided into two groups:

1. Ointments that have a local (local) effect directly on the upper layer of the epidermis of the skin or the surface of the mucous membrane (for example, dermatol, zinc and other ointments used to treat dermatitis, eczema and other skin diseases).

2. Ointments with resorptive action, penetrating deeply into the skin or mucous membrane, reaching the bloodstream and lymph and having a general effect on the entire body.

Pastes – these are types of ointments containing at least 25% powdery substances; the amount of powdery substances in the paste usually does not exceed 60-65%; the pastes soften at body temperature.

Pastes consist of medicinal substances, ointment bases and indifferent powders (thickeners), starch, talc, white clay, zinc oxide. They have a denser dough-like consistency. Pastes are non-dosed dosage forms.

Suppositories– dosage forms that are solid at room temperature and melt or dissolve at body temperature. There are rectal and vaginal suppositories.

7.Solid dosage forms

Solid dosage forms include tablets, dragees, granules, powders, capsules, caramels, pencils, pills.

Pills- a solid dosed dosage form obtained by pressing medicinal substances, a mixture of medicinal and excipients, or forming medicinal masses and intended for internal, sublingual, external or parenteral use.

Positive qualities include:

Ease of use by the patient;

Ease of transportation;

Ease of storage (compared to powders, tablets are less susceptible to moisture, air and light);

Accuracy of dosing of medicinal substances introduced into tablets in mass production conditions

Flaws:

Medicines in tablet form have a slower onset of action than medicines in powder form because the tablets must first disintegrate; only then do the medicinal substances begin to dissolve and be absorbed in the body;

When storing tablets for a long time, chemical changes may occur in them;

Tablets may cause mechanical or chemical irritation of the mucous membrane of the digestive tract;

Tablets cannot be prescribed to children and people who cannot swallow them or who have lost this ability for one reason or another.

Dragee - solid dosage form for int early use, obtained by repeated layering (panning) of medicinal and auxiliary substances onto sugar granules (grains).

Difficult-to-tablet medicinal substances can be produced in the form of dragees. Positive and negative qualities dragees are similar to those of tablets. Dragees allow you to hide the unpleasant taste of medicinal substances, reduce their irritating effect, and protect them from the influence of external factors.

However, in this dosage form it is difficult to ensure the accuracy of dosing of medicinal substances, to achieve their disintegration in the required time frame, and rapid release. Dragee Not recommended for children

Granules - non-dosed solid dosage form in the form of homogeneous particles (grains, grains) various shapes(round, cylindrical or irregular) for indoor use. Medicinal substances are usually released in granules, having unpleasant smell, taste, local irritant effect, etc., but characterized, as a rule, by low toxicity.

Powders - a solid dosage form for internal and external use, consisting of one or more crushed substances and having the property of flowability.

Positive qualities of powders:

High pharmacological activity associated with fine grinding of medicinal substances.

Portability and greater storage stability compared to liquid dosage forms.

Ease of manufacture (simplicity of technology) compared to tablets, dragees and pills.

Possibility of adjusting the degree of dispersion.

Versatility of the composition. The composition of powders may include inorganic and organic substances, including plant and animal origin, as well as a small amount of liquid and viscous substances.

Negative qualities of powders as a dosage form.

The action of medicinal substances is slower compared to solutions, since powders must dissolve before being absorbed.

Some substances in powders may change properties under the influence of the environment

Some medicinal substances in powder form have an irritating effect on the mucous membrane (potassium and sodium bromides, etc.).

Medicinal substances that have a bitter taste, are odorous and coloring, are inconvenient and unpleasant to take.

Powders can be purchased foreign odor, adsorbing vapors of odorous substances.

By method of application: internal and external (powders, smelling, for insufflation).

By composition: simple and complex.

By nature of dosing: undivided (dispensed to the patient in bulk, the patient independently doses) and divided (dosing is carried out in a pharmacy).

We make demands to powders: flowability; homogeneity; permissible deviations in the mass of individual doses; color, taste, smell, packaging and design, compliance with the ingredients included.

Capsules - dosage dosage form consisting of a drug enclosed in a shell.

Advantages:

Dosing accuracy.

Protecting the medicinal substance from exposure to light, air and moisture.

Exception bad taste and the smell of the medicinal substance.

Good appearance.

The ability to quickly swell, dissolve and be absorbed.

High bioavailability.

Full mechanization and automation of production.

Negative qualities of capsules:

The high hygroscopicity of gelatin, from which capsule shells are mainly produced.

Difficulty swallowing.

Caramels (lozenges, troches)– a solid dosage form obtained by mixing medicines with sugar and molasses. Caramels serve to influence the oral mucosa due to their complete absorption; during the resorption process they also affect the upper Airways.

8. Dosage forms for injections. Their advantages over other forms. Requirements for them.

Injectable dosage forms include solutions for injection (aqueous or non-aqueous, for example, oil), suspensions (suspensions and emulsions), extracts from animal or plant tissues (new galenic preparations), as well as solid substances that are dissolved with the required amount of solvent immediately before administration, infusion solutions.

The widespread use of dosage forms for parenteral administration is facilitated by a whole a number of advantages TV:

Speed ​​of action (in some cases the action medicinal product develops within a few seconds);

More complete bioavailability (drugs are administered bypassing the body’s protective barriers such as the gastrointestinal tract and liver, which can destroy drugs);

Accuracy and convenience of dosing of medicinal substances;

Possibility of administering medications to unconscious patients if act of swallowing, the ability to administer drugs that are destroyed in the gastrointestinal tract,

The sensations are completely relieved; associated with the unpleasant odor and taste of drugs.

Since injectable drugs enter the body bypassing many biological barriers, these dosage forms there are certain requirements:

Sterility;

Non-pyrogenic - injection of finished dosage forms should not cause an increase in body temperature;

No mechanical impurities;

Stability both during the manufacturing process of injectable drugs and during their storage;

Isotonicity: for some solutions, such as isotonic sodium chloride solution.

At the same time, the injection method of administering drugs also has negative sides:

Due to the fact that drugs are administered bypassing the body's protective barriers, serious danger introduction of infection

When administering drugs into the vascular bed (arteries, veins), there is a risk of embolism due to the entry of solid particles or air bubbles if their diameter exceeds the diameter of the vessel

Soreness injection method, the patient’s negative reaction “to a syringe and a white coat”;

The need for special tools: syringe, infusion system, etc.;

The presence of highly qualified medical personnel, since inept administration of the solution can lead to injury to blood vessels, nerve endings, formation of abscesses, hematomas, etc.

9. Liquid dosage forms for oral administration, their characteristics.

Liquid dosage forms include solutions, infusions, tinctures, extracts, emulsions, suspensions, mixtures, mucus.

Advantages of liquid dosage forms:

Drugs in liquid dosage forms are in dissolved or crushed form, which facilitates and accelerates absorption, causing the onset of more quick effect than when taking drugs in other forms, for example, solid ones.

Taking liquid dosage forms for internal use is more convenient than, for example, tablets that must be swallowed without chewing and washed down with liquid

Disadvantages of liquid dosage forms:

Most liquid dosage forms are unstable during storage: they are prepared before use and released to the patient for use within 3-5 days.

When storing the drug in liquid dosage form for a long time, the concentration may change active ingredients due to solvent evaporation.

The method of dosing liquid dosage forms is not entirely accurate, because... the patient himself doses individual doses of the drug (drops, spoons, etc.).

Solutions – this is a liquid dosage form obtained by dissolving a drug (solid or liquid) in any liquid (solvent). Purified water is most often used as a solvent, less often - ethanol, glycerin and liquid oils.

Depending on the solvent used, solutions are divided into and aqueous, alcoholic, oily. According to the method of administration, solutions are divided into solutions for internal use, solutions for external use and solutions for injections.

Solutions for internal use are prepared with purified water, prescribed for 3-4 days and stored in the refrigerator. Such solutions are measured in tablespoons, dessert spoons, and teaspoons, graduated cups, and drops.

Suspensions - liquid dosage forms, which are dispersion systems in which relatively large solid particles of the drug (dispersed phases) are suspended in a liquid (dispersion medium) - water, glycerin, liquid oils. Suspensions, like colloidal solutions, are heterogeneous systems, but unlike them, they are turbid liquids, the particles of which are visible under a microscope. These particles do not dialyze or diffuse.

When preparing suspensions, the solid substance is first crushed to a finely dispersed state, then dispersed many times in ultrasonic and other installations. Suspensions are prescribed for external and internal use. Some sterile suspensions can be administered intramuscularly or into body cavities.

The use of medicinal substances in the form of suspensions has a number of advantages.

The introduction of insoluble substances in a finely divided state into a liquid dispersion medium makes it possible to obtain a larger total surface area of ​​the solid phase and thereby provide a better therapeutic effect than when using powders and tablets.

Medicinal substances used in the form of suspensions, as a rule, have a prolonged effect compared to medicinal substances used in the form of solutions.

Suspensions are prescribed in shortened or expanded form. The signature states: “Shake well before use.”

Emulsions - a liquid dosage form, which is a two-phase dispersed system consisting of mutually insoluble liquids, intended for internal or external use. The dispersion medium in the emulsion is water, and the dispersed phase is water-insoluble liquids (fatty or essential oils, balms and other substances). When using drugs in the form of emulsions, their effect on the body is significantly accelerated, which is explained by the large free surface area of ​​the crushed substance, which increases the possibility of its interaction with tissues. The fragmentation of the substance helps to increase its adsorbing properties. The positive qualities of the emulsion as a dosage form are its ability to mask the unpleasant taste fatty oils and some substances, soften the irritating effect of the drugs used on the mucous membranes.

Slime - a thick viscous liquid resulting from the dissolution or swelling of crushed medicinal raw materials in water, containing mucous substances. Mucus is used for external or internal use to reduce the irritating effect of drugs on the tissues of the patient’s body, and also as an enveloping agent for burns and inflammatory processes.

Tinctures - a liquid dosage form, which is often an alcoholic extract from medicinal plant materials, obtained without heating and removing the extractant. Tinctures are clear, colored liquids that have the taste and smell of the plants from which they are prepared. Tinctures are intended for internal and external use; tinctures are divided into simple and complex.

Extracts - dosage form, which is a concentrated extract from medicinal plant materials, intended for internal or external use.

Infusions and decoctions – these are aqueous extracts from medicinal raw materials, differing in the extraction mode. Infusions are most often prepared from leaves, flowers, herbs, i.e. from soft parts of plants. The crushed medicinal raw materials are placed in a preheated infusion vessel, filled with a certain amount of purified water at room temperature and heated in a boiling water bath for 15 minutes. Then the infusion is cooled at room temperature, filtered and purified water is added to the prescribed volume of liquid.

Decoctions are prepared from solid parts of plants (roots, rhizomes, bark, tubers), following a technology similar to that used for preparing infusions. The raw material is heated in a boiling water bath with frequent stirring for 10 minutes and filtered (while hot). The rest of the raw material is squeezed out. The volume of the decoction is adjusted to the desired volume using purified water. Infusions and decoctions are used internally and externally (for lotions, compresses, rinses), as well as for enemas.

Potions – a liquid dosage form, which is a mixture of various drugs dissolved in a liquid or suspended in it. Purified water, and sometimes infusions and decoctions, are used as a solvent in the preparation of potions.

The mixtures can be clear, cloudy, or even have sediment. The mixture should be shaken before use. Medicines are prescribed mainly internally, dosed with spoons. Prepared in pharmacy conditions, shelf life 3-4 days

Dosage form - a state given to a medicinal product that corresponds to the route of its administration and method of use and ensures the achievement of the required therapeutic effect.

8.1. GENERAL REQUIREMENTS FOR DOSAGE FORMS

Types of classification of dosage forms

Classification helps to characterize individual phenomena and facts; depending on belonging to one or another group, classification allows one to foresee still unknown or unstudied phenomena and objects.

The task of dosage form technology is to create a variety of products used as medicines. Their properties, nature and ways of creating them are very diverse and require appropriate classification. In technological industries, correct classification allows you to determine in advance the optimal manufacturing scheme for a particular product. In a training course, it makes learning the material easier. However, it should be borne in mind that any classification is conditional, so its further improvement is possible. Pharmacists (pharmacists) must be familiar with all types of classifications of dosage forms.

Currently, there are several classification systems for dosage forms based on different principles. Each classification, to one degree or another, gives the subject a certain harmony.

Most often in pharmacy, 4 types of classification of dosage forms are used:

According to the state of aggregation;

Depending on the method of application or dosing method;

Depending on the method of administration to the body;

Dispersological.

8.2. CLASSIFICATION OF DOSAGE FORMS ACCORDING TO AGREGATE STATE

All dosage forms are divided into 4 groups according to their state of aggregation: solid, liquid, soft, gaseous.

8.2.1. Solid dosage forms

Pills- dosage dosage form obtained by pressing or forming a medicinal product, medicinal mixtures and excipients.

Dragee- a dosage dosage form of a spherical shape, obtained by repeated layering of drugs and excipients onto granules.

Granules- homogeneous particles (grains, grains) of medicines, round, cylindrical or irregular shape size 0.2-0.3 mm.

Powders- dosage forms that are free-flowing; distinguish:

Powders are simple (single-component) and complex (from 2 or more components);

Divided into separate doses and undivided.

Fees- a mixture of several types of cut, crushed into coarse powder or whole medicinal raw materials of plants, sometimes with the addition of other medicines.

Capsules- dosed powdered, granulated, sometimes liquid medicines, enclosed in a shell of gelatin, starch, or other biopolymer.

Spansulas- capsules in which the content is a certain amount of granules or microcapsules.

Pencilsmedicinal (medical) - cylindrical sticks 4-8 mm thick and up to 10 cm long with a pointed or rounded end.

Medicinal films - dosage form in the form of a polymer film.

8.2.2. Soft dosage forms

Ointments- dosage forms of soft consistency for external use; When the ointment contains a powdery substance of more than 25%, the ointment is called a paste.

Plasters- dosage form for external use in the form of a plastic mass that has the ability to adhere to the skin after softening at body temperature; The patches are applied to a flat surface of the body.

Suppositories(suppositories) - solid at room temperature and melting at body temperature, dosage forms intended for administration into body cavities (rectal, vaginal suppositories); suppositories can be shaped like a ball, cone, cylinder, cigar, etc.

Pills -dosage dosage form in the form of a ball weighing from 0.1 to 0.5 g, prepared from a homogeneous plastic mass containing drugs and Excipients; a pill weighing more than 0.5 g is called a bolus.

8.2.3. Liquid dosage forms

Solutions- dosage forms obtained by dissolving one or more drugs.

Suspensions(suspensions) - systems in which a solid substance is suspended in a liquid and the particle size ranges from 0.1 to 10 microns.

Emulsions- dosage forms formed by liquids insoluble in each other.

Infusions and decoctions- aqueous extracts from medicinal plant materials or aqueous solutions standardized extracts.

Slime -dosage forms of high viscosity, as well as those prepared using starch or plant materials containing it.

Liniments -thick liquids or gelatinous masses.

Liquid plasters- dosage forms that leave an elastic film when applied to the skin.

Medicinal syrups - a solution of a medicinal substance in a thick sugar solution.

Tinctures- alcoholic, aqueous-alcoholic or alcohol-etheric transparent extracts from medicinal plant materials, obtained without heating and removing extractants.

Extracts- concentrated extracts from medicinal plant materials; There are liquid, thick and dry types of extracts.

8.2.4. Gaseous dosage forms

Aerosols- dosage forms in special packaging in which solid or liquid drugs are contained in gas or in a liquefied gaseous solvent.

Classification by state of aggregation is convenient for the primary separation of dosage forms. The physical state partially determines the speed of action of the drug and is associated with certain technological processes.

8.3. CLASSIFICATION OF DOSAGE FORMS DEPENDING ON THE METHOD OF APPLICATION OR DOSING METHOD

In this classification, dosage forms are divided into 2 classes:

Dosed (powders, solutions and others, divided into separate doses);

Undosed (ointments, powders, bath powders, etc.).

Note 1.Medicines are liquid dosage forms for internal use, which, although dispensed in one bottle, are dosage forms, since their use requires dosing with a tablespoon, dessert or teaspoon.

Note 2.Some dosage forms, depending on medical manipulations, are called: powders, powders, rinses, poultices, lotions, mixtures, drops. In particular, drops are liquid dosage forms intended for administration in the form of drops into the mouth, eyes, ears, etc. Name data

dosage forms are outdated, although they fully define the medical procedures necessary for their use.

8.4. CLASSIFICATION OF DOSAGE FORMS DEPENDING ON THE METHOD AND ROUTE OF ADMINISTRATION

INTO THE ORGANISM

This classification, based on the method of application of dosage forms, is more advanced and allows us to predict biopharmaceutical factors affecting the effectiveness of application. All dosage forms are divided into 2 classes.

Enteral forms - introduced into the body through the gastrointestinal tract. Parenteral forms - administered, bypassing the gastrointestinal tract:

By application to the skin and mucous membranes of the body;

By injection into the vascular bed (artery, vein), under the skin or muscle;

By inhalation, inhalation.

Enteral administration includes the following routes of administration: through the mouth, under the tongue, through the rectum. The oldest and most common method is oral (from lat. per- through, oris- mouth). This is the simplest and convenient way; It is convenient to take both solid and liquid dosage forms by mouth.

For some substances oral route administration is ineffective, since the substances are destroyed either under the influence of intestinal enzymes, or in acidic environment stomach, for example, pancreatin, insulin, etc. In addition, with this method of administration, the drug is detected in the bloodstream no earlier than 30 minutes, so the oral route of administration cannot be used to provide rapid medical assistance.

Modification this method is sublingual administration (under the tongue). Medicinal substances are absorbed quite quickly through the mucous membrane oral cavity, enter the circulatory system, bypassing the gastrointestinal tract and liver, where inactivation of medicinal substances is possible. Sublingual substances with high activity and the ability to be inactivated by stomach acid or intestinal enzymes (sex hormones, validol, nitroglycerin) are prescribed.

The rectal route of administration - through the rectum - is convenient in pediatric practice, as well as for patients with unconscious. Absorption of medicinal substances occurs within 7-10 minutes, and they enter the general bloodstream, bypassing the liver. Medicinal substances are not affected by enzymes of the digestive tract.

To parenteral (from lat. par enteron- past the intestines) methods of administration include application to the skin, easily accessible mucous membranes, injection and inhalation routes of administration.

Many dosage forms (powders, ointments, pastes, liniments) are used to affect the skin. Action medicinal substances can be general and local. Mustard plasters placed on the chest cause expansion blood vessels lower limbs. Phenol, camphor, iodine, and medications in the form of emulsions are well absorbed through the skin.

The application of drugs to the mucous membranes of the eye, intranasal, and ear is widely used. The mucous membranes have a good absorption function due to the presence large quantity capillary blood vessels. The mucous membranes are devoid of a fatty base, so they absorb aqueous solutions of medicinal substances well.

Special place Among parenteral dosage forms, inhalation drugs (from Lat. un habare- inhale). With their help, medicinal substances are administered through the respiratory tract, for example gases (oxygen, nitrous oxide, ammonia), highly volatile liquids (ether, chloroform). Low-volatile liquids are administered using inhalers. The intensity of inhalation absorption of medicinal substances is explained by the huge surface of the pulmonary alveoli (50-80 m2) and the abundant network of blood vessels in the human lungs. Noted fast action medicinal substances, since they directly penetrate into the bloodstream.

Parenteral dosage forms include injectable dosage forms administered using a syringe. Medicinal substances quickly penetrate the blood and have an effect within 1-2 minutes or earlier. Injectable dosage forms are required when providing urgent help, convenient for unconsciousness and for administering drugs that are destroyed in gastrointestinal tract. Due to the method of administration of injectable dosage forms, special requirements are imposed on them: sterility, non-pyrogenicity, absence of mechanical inclusions.

Classification of LF according to route of administration is mainly important for the doctor. It is more perfect than classification by state of aggregation; has technological significance, since depending on the method of administration, certain requirements are imposed on dosage forms, the fulfillment of which must be ensured by the technological process. However, the disadvantage of the classification is that different dosage forms that differ from each other in type and technology belong to a single group, for example, powders and mixtures (orally).

8.5. DISPERSOLOGICAL CLASSIFICATION OF DOSAGE FORMS (BASED ON THE STRUCTURE OF DISPERSE SYSTEMS)

All complex dosage forms are, by their nature, diverse disperse systems. The distributed substance constitutes the dispersed phase of the system, and the carrier constitutes a continuous dispersion medium.

This classification was created based on the following characteristics:

The presence or absence of a connection between particles of the dispersed phase and the dispersion medium;

Aggregate state of the dispersion medium;

Fineness of the dispersed phase.

IN modern classification dispersed systems are distinguished

2 main groups:

Freely dispersed systems;

Cohesively dispersed systems.

8.5.1. Freely dispersed systems (systems without connections between particles)

These systems are characterized by the absence of interaction between particles of the dispersed phase. Thanks to this, they can move freely relative to each other under the influence of thermal motion or gravity. The particles of the dispersed phase are not connected to each other into one continuous network. Such systems have fluidity and all the properties characteristic of liquids. These systems are called dispersed, since the dispersed phase is crushed according to

3 dimensions: length, width and thickness. Subject to availability

or the absence of a dispersion medium and its state of aggregation, the systems are divided into several subgroups. A. Systems without a dispersion medium

In this case, the solid particles are not distributed in the mass of the carrier, i.e. there is no dispersion medium (it is not introduced into the LF manufacturing process). Based on their dispersion, these systems are divided into coarse (collections) and fine (powders). Dosage forms of this group are obtained by mechanical grinding and mixing.

The main properties of systems without a dispersion medium are:

Large specific surface area;

Corresponding supply of free surface energy;

Increased adsorption properties;

The subordination of particles to the action of gravity (flowability). B. Systems with liquid dispersion medium

This subgroup includes all liquid dosage forms:

a) solutions - homogeneous systems with maximum grinding of the dispersed phase (1-2 nm) associated with the solvent in the absence of an interface between the phases;

b) sols, or colloidal solutions. The diameter of the particles does not exceed 100 microns, the interface between the phases is outlined (ultramicroheterogeneous systems);

c) suspensions (suspensions) - microheterogeneous systems with a solid dispersed phase and a liquid dispersion medium. The interface between the phases is visible to the naked eye. The particle diameter does not exceed 100 microns;

d) emulsions - dispersed systems consisting of 2 liquids, insoluble or slightly soluble in each other, the phase and medium are mutually immiscible liquids. The diameter of droplets of the liquid phase does not exceed 20 microns;

e) combinations of the listed systems.

Systems with a liquid dispersion medium are prepared by dissolution, suspension and emulsification. This subgroup of systems includes mixtures, drops, rinses, lotions, and aqueous extracts. A special place in this subgroup is occupied by injectable dosage forms (solutions, sols, suspensions, emulsions). They require sterility and aseptic manufacturing conditions.

B. Systems with plastic or elastic-viscous dispersion medium

In terms of its state of aggregation, the dispersion medium occupies an intermediate position between a liquid and a solid. Depending on the dispersion and state of aggregation of the phase, these systems are divided, similarly to systems with a liquid dispersion medium, into the following types:

a) solutions;

b) sols;

c) suspensions;

d) emulsions;

e) combined systems.

These systems can also be divided as follows:

Shapeless systems that look like a continuous mass (ointment, paste), which cannot be given a geometric shape;

Formed systems having certain regular geometric shapes (candles, balls, sticks).

D. Systems with solid dispersion medium Systems of this class include:

Aerosols are analogues of colloidal solutions;

Mists are analogues of emulsions;

Dusts are analogues of suspensions.

8.5.2. Cohesively dispersed systems

These systems consist of small particles of solid bodies in contact with each other and welded at the points of contact due to molecular forces, forming unique spatial networks and frameworks in a dispersion medium. The phase particles are deprived of the ability to move and can only perform oscillatory movements.

Cohesively dispersed systems can contain a dispersion medium or be free from it.

Cohesive-dispersed systems without a dispersion medium are solid porous bodies obtained by compressing or gluing powders (granules, pressed tablets).

Impregnated cohesive dispersed systems. Currently, this subgroup does not include dosage forms. It includes bases that are used to make ointments and suppositories.

This chapter presents 3 main classification systems for dosage forms. Their advantages and disadvantages are given in table. 8.1.

Table 8.1. Advantages and disadvantages various systems classifications

Control questions

1. What is the need for classification of dosage forms?

2. For what purpose is the classification of dosage forms by state of aggregation used?

3. What is the importance of classifying dosage forms by route of administration?

4. What groups are dosage forms divided into depending on the route of administration?

5. List positive sides and shortcomings in classifying dosage forms by route of administration.

6. What is the essence of the dispersological classification and what is its significance for the technology of dosage forms?

7. What are the basic principles of dispersological classification?

8. What is the difference between freely dispersed systems and coherently dispersed systems?

sleepy?

9. How dosage forms are divided - dispersed systems in

depending on the state of aggregation of the dispersion medium?

10. What disperse systems are dosage forms divided into depending on the fineness of the dispersed phase?

11. What are the general requirements for dosage forms?

Tests

1. Classification of dosage forms by dividing into groups allows:

1. Anticipate yet unknown or unstudied phenomena and objects.

2. Name the drugs correctly.

2. Dosage form - attached medicine or medicinal plant raw materials, a state convenient for use in which the following is achieved:

1. Necessary therapeutic effect.

2. Required geometric shape.

3. General requirements requirements for dosage forms:

1. Compliance medicinal purpose, the bioavailability of the drug in a given dosage form and the corresponding pharmacokinetics.

2. Uniformity of distribution of medicinal substances in the mass of auxiliary ingredients and hence the accuracy of dosing.

3. Stability during shelf life.

4. Compliance with microbial contamination standards, ease of administration, possibility of correcting unpleasant taste; compactness.

5. Compliance with specific requirements reflected in the Global Fund or other regulatory documents.

6. Storage stability.

4. Types of classification of dosage forms:

1. According to the state of aggregation.

2. Depending on the method of application or dosing method.

3. Depending on the method of administration to the body.

4. Dispersological classification.

5. Depending on the potent and toxic substances included in the composition.

5. Depending on the route of administration or dosage method, dosage forms are divided into the following classes:

1. Simple.

2. Complex.

3. Dosed.

4. Undosed.

6. Medicines - liquid dosage forms for internal use:

1. Dosable drops.

2. Dosed with spoons.

3. Representing a mixture of medicinal substances.

7. Depending on the method and route of administration into the body, dosage forms are divided into:

1. Enteral.

2. Parenteral.

3. Internal.

4. External.

8. Enteral forms are dosage forms introduced into the body through:

1. Mouth.

2. Rectum.

9. Parenteral forms are dosage forms administered by:

1. Application to the skin and mucous membranes of the body.

2. Injections into the vascular bed (artery, vein), under the skin or muscle.

3. Inhalation, inhalation.

10. The dispersological classification was created based on the following characteristics:

1. The presence or absence of connection between particles of the dispersed phase and the dispersion medium.

2. Aggregate state of the dispersion medium.

3. Fineness of the dispersed phase.

11. The dispersological classification distinguishes the following main groups:

1. Freely dispersed systems.

2. Cohesively dispersed systems.

12. Freely dispersed systems are systems characterized by:

1. The presence of interactions between particles of the dispersed phase.

2. Lack of interaction between particles of the dispersed phase.

13. Systems without dispersion medium:

1. Fees.

2. Powders.

3. Aerosols.

14. Systems with liquid dispersion medium:

1. Solutions.

2. Sols, or colloidal solutions.

3. Suspensions.

4. Emulsions.

5. Combinations of the listed systems.

15. Cohesively dispersed systems without a dispersion medium are solid porous bodies obtained by:

1. Mixing without grinding.

2. Compression.

3. Bonding powders.

16. Impregnated cohesively dispersed systems are:

1. Wet dosage forms.

2. Bases that are used to make ointments and suppositories.