s te ri le do sa ge f or ms - usmf

STERILE DOSAGE FORMS

Lecturer – Dr. Cristina Ciobanu,

Associat Professor

Drug Technology Department

Injectable solutions

Dr. CiobanuCristina

Sterile forms prepared in pharmacy:

■ injectable solutions;

■ ophthalmologic pharmaceutical dosage forms;

■ solutions for newborns;

■ solutions for infants under 1 year old;

■ dosage forms with antibiotics;

Dr. Ciobanu Cristina

CHARACTERISTICS OF INJECTABLE

SOLUTIONS


Injection dosage forms - a specific

group of drugs that require special

conditions of preparation, the strictest

adherence to aseptic, technological

discipline, full responsibility for the

preparation, quality control and design to

dispensing drugs.


■ Injectable dosage forms differ from all other drug dosage forms, because they are injected directly into body tissue through the primary protective systems of the human body, the skin, and mucous membranes.


■ They must be exceptionally pure and free from physical, chemical, and biological contaminants.

■ These requirements place a heavy responsibility on the pharmaceutical industry to practice current good manufacturing practices (cGMPs) in the manufacture of parenteral dosage forms and on pharmacists and other health care professionals to practice good aseptic practices (GAPs) in dispensing parenteral dosage forms for administration to patients.


Advantages

exact dosing of medicinal

substances;

rapid effect: immediate

effect in case of IV route;

administration in unconscious

state, while vomiting;

avoiding some side effects

(gastrointestinal disorders);


CLASSIFICATION

Injections may be classified in six general categories:

■ 1. Solutions ready for injection

■ 2. Dry, soluble products ready to be combined with a solvent just prior to use

■ 3. Suspensions ready for injection

■ 4. Dry, insoluble products ready to be combined with a vehicle just prior to use

■ 5. Emulsions

■ 6. Liquid concentrates ready for dilution prior to administration


MANDATORY QUALITIES:

■ sterility

■ lack of insoluble particulates

■ non pyrogenic

■ innocuity

■ stability

QUALITIES WANTED:

■ Isotonic

■ Osmotic pressure

■ Izohidry and tampon capacity

■ Tolerance

■ pH Dr. Ciobanu Cristina

Sterile formulations must meet a number of special

criteria such as:

REQUIREMENTS FOR ASEPTIC

MANUFACTURING OF STERILE MEDICINAL

PRODUCTS


Injection solutions are prepared in

aseptic unit.


Aseptic conditions - defined conditions,

and complex institutional arrangements

required to enable to save the drugs from

getting into these microorganisms.


Layout of parenteral processing


Production facilities of parenterals

The production area where the parenteral preparation are manufactured can be divided into five sections:

CLEAN-UP AREA:

All the parenteral products must be free from foreign particles & microorganism.

Clean-up area should be withstand moisture, dust & detergent.

This area should be kept clean so that contaminants may not be carried out into aseptic area.

PREPARATION AREA:

In this area the ingredients of the parenteral preparation are mixed & preparation is made for filling operation.

It is not essentially aseptic area but strict precautions are required to prevent any contamination from outside.


ASEPTIC AREA:

The parenteral preparations are filtered, filled into final container & sealed should be in aseptic area.

The entry of personnel into aseptic area should be limited & through an air lock.

Ceiling, wall & floor of that area should be sealed & painted.

The air in the aseptic area should be free from fibers, dust and microorganism.

The High efficiency particulate air filters (HEPA) is used for air.

UV lamps are fitted in order to maintain sterility


QUARANTINE AREA:

After filling, sealing & sterilization the parenteral product are held up in quarantine area.

Randomly samples were kept for evaluation.

The batch or product pass the evaluation tests are transfer in to finishing or packaging area.

FINISHING & PACKAGING AREA:

Parenteral products are properly labelled and packed.

Properly packing is essential to provide protection against physical damage.

The labelled container should be packed in cardboard or plastic container.

Ampoules should be packed in partitioned boxes


For the manufacture of sterile pharmaceutical preparations, four grades of clean areas are

distinguished as follows

■ Grade A: The local zone for high-risk operations.

■ Grade B: In aseptic preparation and filling, this is the background environment for the Grade A zone.

■ Grades C and D: Clean areas for carrying out less critical stages in the manufacture of sterile products or carrying out activities during which the product is not directly exposed (i.e. aseptic connection with aseptic connectors and operations in a closed system).


Clean room and clean-air device classification


■ The production area must be properly sanitized to ensure the quality of the approved products.

■ Walls: Wash with water and liquid soap before producing each series of products. The operation is performed by the caretaker.

■ Windows and doors: Wash with water and detergents (Ajax with ammonia and Ajax with formol) before each product series is produced. The operation is performed by the caretaker.

■ Tables and shelves:

■ Washing: Perform after each operation with brush, water and ecologically non-corrosive detergent. Rinse with water to remove traces of detergent.

■ Disinfection: disinfect with 6% hydrogen peroxide solution or 1% chloramine "B" solution.

■ The operations are performed by the caretaker.


■ Personnel

■ As humans may be a source of contamination with bacteria, endotoxins, insoluble particulate matters, and other foreign matters, it is essential to minimize personnel intervention as a possible source of contamination in manufacturing terminally sterile products in order to eliminate a human source of contamination and non-conforming products.

■ Personnel who engage in the manufacture of terminally sterile products should repeatedly receive education and training on the concepts and practical procedures required to perform assigned tasks and maintain morale and skills at high levels.

■ If personnel are assigned to operate sterilizers, they should be educated on the structure, characteristics, operating procedures, operating condition-supervising procedures, and maintenance and control procedures of the equipment.


METHODS OF STERILIZATION


Sterility means the complete absence of any viable microorganism in a drug product. The specification of sterility is unchanging and is independent of the kind of manufacturing process: sterilisation of the final product in its container closure system or aseptic manufacturing.


Definition of Pyrogen ■ Pyrogens are fever producing

substances, which are metabolic products of microorganisms.

■ Chemically, they are lipid substances associated with a carrier molecule, which is usually a polysaccharide. The carrier may also be a peptide. These carriers increase the solubility of the lipid. Pyrogens are produced by many microorganisms including bacteria, yeasts and moulds.

■ Most potent pyrogens are the endotoxins produced from the cell walls of the Gram- negative bacteria.

■ Pyrogens have a high molecular weight, more than 1,000 Da


If unintentionally, pyrogens are injected into a patient, they may bring about the following physiological changes: Erythema at the injection site Pain in the legs and trunk General discomfort High temperature

the effect of rise of temperature may be fatal.


Contamination sources for injectable solutions can be:

■ production space;

■ materials

■ solvents;

■ glass ampoules and vials;

■ staff;

■ glass containers for packaging;


The microorganisms can be destroyed by:

sterilization


Methods of sterilization most used

■ sterilization through dry heat;

■ sterilization with moist heat under pressure;

■ sterilization through filtration;

passing the solutions through the activated charcoal column;

passing the solutions through filters;

■ sterilization with gas;

■ sterilization with chemical substances;


■DRY HEAT STERILIZATION

Principle: The killing of microorganisms by heat is a function of the timetemperature combination used. If the temperature is increased then the time required for killing all the bacteria will be decreased.

Condition: Cycles recommended as per Ph are:

■ A minimum of 1800 C for not less than 30 minutes.

■ A minimum of 1700 C for not less than 1 hour.

■ A minimum of 1600 C for not less than 2 minutes.



■ Applications

MEDICINAL SUBSTANCE thermostable atropine sulfate; boric acid; sulfadimezine;

AUXILARY SUBSTANCE - Fats, oils and greasy materials (like petroleum jelly) those are impermeable to moisture.

AUXILARY MATERILAS

Glass ware ( e.g. test tubes, Pasteur pippettes, petri dishes, flasks, glass syringes etc )

Porcelain and metal equipment such as forceps, scalpels, scissors etc.

DRY HEAT STERILIZATION

The efficiency of the sterilization with dry and hot air depends on:

■ temperature;

■ sterilization time;

■ conductivity degree of the objects that are to be sterilized;

■ how is the object positioned inside the device;


Moist heat sterilization

Principle: Mechanism of killing of microorganisms: Bacterial death by moist heat is due to denaturation and coagulation of essential protein molecules (enzymes) and cell constituents. Conditions: The USP and BP recommended the following condition:

■ Pressure : 15 lb/square inch (psi)

■ Temperature : 120 ±2°C


Volume of solution Sterilisation time

Till 100 ml 8 min

100 ml 12 min

More than 100 ml 15 min

Advantages of moist heat sterilization High heat content plus rapid heat transfer.

Destroys micro-organism more efficiently than dry heat.

It can be used for a large number of injections, ophthalmic solutions, irrigants, dialysis fluids etc.

It rapidly penetrates porous materials and is therefore very suitable for sterilizing surgical dressings and materials.

The process is adaptable for plastic containers and some other special dosage forms.

Disadvantages of moist heat sterilization

It is not suitable for anhydrous materials such as powders and oils.

It cannot be used for thermo labile substances.



Autoclaves

GASEOUS STERILIZATION ■ This process involves exposure of materials tosterilize gasses such as

ethylene oxide, formaldehyde, glutaraldehyde, propylene oxide.

■ ETHYLENE OXIDE

■ Ethylene oxide is the only gas that is successfully used on a large scale of industrial and medical applications.


Factors affecting gaseous sterilization Sterilization efficiency is influenced by the concentration of ethylene-

oxide

the humidity of the sterilizing atmosphere

the temperature of sterilization

time of exposure

physical nature and permeability of the load.

atmospheric preconditioning of the load

before sterilization.

STERILIZATION BY RADIATION

Radiation can be divided into two groups:

1. Electromagnetic waves: (i) infra-red radiation (IR)

(ii) ultraviolet radiation (UV)

(iii)X-rays

(iv)gamma rays

2. Streams of particulate matter (i) alpha radiation

(ii) beta radiation

For sterilization infrared, ultraviolet, gamma radiation and high

velocity electrons (a type of beta radiation) are used for

sterilization.


STERILIZATION BY FILTRATION ■ This method is used for sterilizing thermo-labile solutions, which will otherwise be degraded by other conventional heating methods.


MEMBRAINE FILTERS are made of cellulose-derivative (acetate or

nitrate). They are very fine. They are fixed in some suitable

holders. Nominal pore size is 0. 22 ± 0. 02 mm or less is required. The

membranes are brittle when dry. In this condition they

can be stored for years

GLASS FILTERS

Borosilicate glass is finely powdered in a ball-mill and the particles of

required size are separated. This is packed into disc mounted and heated

till the particles get fused.

ACTIVATED CHARCOAL COLUMN – for injectable water.

PREPARATION OF INJECTABLES


SOLVENTS AND VEHICLES

■ WATER AND AQUEOUS VEHICLES

■ -Water for injection

■ -Bacteriostatic water for injection

■ -Sodium chloride injection

■ -Bacteriostatic sodium chloride injection

■ Non-aqueous solvents/Anhydrous

■ fixed vegetable oils - olive oil; apricot oil;

■ alcohols;

■ glycerol;

■ PEGs


■ STERILE WATER FOR INJECTION is a sterile, nonpyrogenic preparation of Water for Injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only to dilute or dissolve drugs for injection.

■ For IV injection, add sufficient amount to a solute to make an approximately isotonic solution. pH 5.0 to 7.0.


Shelf life 24 hours at 8 °C

Methods of Producing Water for Injection

■ Distillation

■ Reverse osmosis

■ Ultrafiltration

■ Deionization

■ Water Chlorinators & Charcoal Filters


http://ispe.info/galleries/journal_ja09/09ja-zoccolante2.pdf

http://ispe.info/galleries/journal_ja09/09ja-zoccolante2.pdf

The solvents used for preparing injectable forms must:

■ correspond to quality norms of the Ph-;

■ not interact with the dissolved substances;

■ not be toxic;

■ not have their own pharmacological action;


ADDED SUBSTANCES

Preservatives

■ -Agents containing mercury in concentration not more than 0.01%

■ -Cationic surfactants

■ -Alcohols up to 2%

■ -Phenols up to 0.5%

■ -Others


Technology process of preparation of solutions for

injection

1. Preparation of aseptic unit and the organization of work in aseptic conditions.

2. Preparation of vessels and auxiliary materials.

3. Preparation of solvents and drugs.

4. Dissolve drugs.

5. Stabilization or isotones solutions

6. First quality control of solutions.

7. Filtering solutions to filling bottles, checking the absence of mechanical inclusions.

8. Closing, leak check, preparation for sterilization (marking).

9. Sterilization.

10. Second quality control and labeling.


STABILITY OF INJECTABLE SOLUTIONS


Stability of drug injection is achieved

compliance with the aseptic conditions of

their preparation, choice of optimal

conditions (temperature, time)

sterilization, antimicrobial use valid tools

to achieve the effect of sterilization at

lower temperatures and also the use of

stabilizers - substances that enhance the

chemical stability injecting drugs in the

solutions.


Stabilizers can be divided into three

groups:

■ substances that provide chemical stabilization - antioxidants that prevent oxidation.

■ substances that prevent the hydrolysis of salts and esters saponification.

■ Antiseptics providing microbiological stabilization.


The main changes in drugs are

chemical processes:


hydrolysis

oxidation

isomerization

Hydrolysis - a reaction of ion

exchange between drugs and water.

Hydrolysis are different classes of

compounds: alkaloids, glycoside,

vitamins, esters, proteins, carbohydrates

and especially salt.

Hydrolysis are only salt in which one or

both components are weak.


Name of matter which

needs to be stabilized Stabilizer

Solutions of salts, formed by weak

bases and strong acids (atropine

sulfate, Scopolamine hydrobromide,

cocaine hydrochloride, pilocarpine

hydrochloride, Novocain, Strychnine

nitrate, Dibazol et al)

Acid hydrochloride (HCl) -10 ml a 0,1 M

solution on 1 l

Novocain of 0,25% - 3 ml a 0,1 M on 1 l

Novocain of 0,5%- 4 ml a 0,1 M on 1 l

Novocain of 1% - 9 ml a 0,1 M on 1 l

Novocain of 2% - 12 ml a 0,1 M on 1 l

Solutions of salts, formed by

strong bases and weak acids

(sodium nitrite, caffeine- benzoate of

sodium, sodium thiosulphate,

euphillin)

Sodium hydroxide (NaOH) 0.1 M

10%, 20% caffeine- benzoate of

sodium- 4 ml 0.1 M on 1 l

30% caffeine- benzoate of sodium- 20

ml 0.1 M on 1 l


Hydrolysis of salts formed by weak base

and strong acid, and their stabilization.

This group includes salts of alkaloids

containing synthetic nitrogen bases

(solutions of salts of novocaine, dybazol,

strychnine nitrate, etc.)..

This group of salts stabilize adding 0.1 M

solution of hydrochloric acid, since excess

hydroxyl ions (OH +3) reduces the degree of

dissociation of water and suppresses

hydrolysis, causing a shift of equilibrium to

the left. Dr. Ciobanu Cristina

Recommended stabilize with hydrochloric

acid solutions: Apomorphini g / h,

atropini sulfate,

dybazoli,

novocaine,

spazmolityni,

strychnine nitrate,

dykayini.

Stabilization of solution for injection,

representing the salt of weak bases and

strong acids by adding 0.1 M hydrochloric

acid solutions.


Rp.: Solutionis Novocaini 0,5% 100 ml

Sterilisa!

Da. Signa


For stabilization the 0.5% solution of novocaine 0.1 M

hydrochloric acid solution to pH 3,8-4,5 taking 4 ml per 1

liter of solution.

Sterilizing at 120С 12 min.

Issuing blue label "for injection", which indicate:

solution of novocaine 0.5% 100 ml for infiltration

anesthesia, aseptically.

Example: the solution of novocaine.

WVD (front side)

Date № recipe

Aquae pro injectionibus q.s.

Novocaini 0,5

Solutionis Аcidi hydrocarbonici (0.1 M) 0,4 ml

Aquae pro injectionibus ad 100 ml

V = 100 ml

Sterilis

Prepared: Signature

Checked: Signature


Hydrolysis of salts formed a strong base

and weak acid


In this case, hydrolytic processes enhanced

in an acidic environment.

To suppress hydrolysis is necessary: a weak

alkaline medium by adding 0.1 M sodium

hydroxide or adding sodium hydrogen

carbonate.

Solutions of caffeine-sodium benzoate, sodium thiosulfate, sodium nitrite.

■ For stabilization of 1 liter of 10 and 20% solutions of caffeine-sodium benzoate Ph recommends adding 4 ml of 0.1 M sodium hydroxide for 1000 ml.

■ For 30% sodium thiosulfate as a stabilizer is added sodium hydrogen carbonate (20 m per 1 liter).


Oxidizing substances

Oxidation are medicinal substances of

different chemical structure: - derivatives

of aromatic amines, fenotiazin, many salts

of alkaloids, salts of bases, vitamins and

other substances containing phenolic,

alcohol, carbonyl groups, amino groups

mobilize with hydrogen atoms.



■ It is known that redox processes strengthened influenced by several factors such as the presence of heavy metal ions, pH value, oxygen, light temperature, etc.

Oxidation process can be slow in ways:

a) introduce a substance that rapidly reacts with alkil radicals, resulting in peroxide will become only part of the radicals:

Ex.: Vicasol, Ascorbic acid.

b) enter the compound, which quickly reacts with peroxide radicals. This will reduce the rate of formation of peroxides and radicals regeneration:

Ex.: phenols and aromatic amines

c) enter substances that stops formation of hydro peroxide R :

Ex.: Sodium metabisulfite and sulfite, Trilon B.


Solutions of easily oxidable matters

(acid ascorbic, vicasol, sodium

salicylate, streptocide, adrenalin

hydrotartrat)

Streptocide 5%, 10% - sodium sulfit

2 g on 1 l of solution

Sodium salicylate 10% -sodium

metabisulfite- a 1 g on 1 l of solution

Acid ascorbic 5% - sodium

metabisulfite- 2 g on 1 l of solution

Solution of glucose Stabilizator of Weibel with

composition:

• sodium chloride- 5,2 g,

• acids chloride - 4,4 ml

• water for the injections to

Stabilizator is added by 5% from

the volume of solution, which

needs to be stabilized.


Name of matter which

needs to be stabilized Stabilizer

Rp.: Solutionis Acidi ascorbinici 5% 50 ml

Sterilisa!

Da. Signa


Sterilizetur – 100 0C, - 15 min.

TECHNOLOGY

stabilize ascorbic acid solutions introduction antioxidant

sodium metabisulfitis 1 g per liter or solution or sodium

sulphite anhydrous 2 g per 1 liter.

In addition, solutions of ascorbic acid strongly acidic. In

order to neutralize the environment of the sodium

carbonate solution is introduced 23.85 g per 1 liter.

Solution of sodium that is formed, askorbinat is pH 6-7.

In aseptic conditions in sterile volumetric flask dissolve

2.5 g of ascorbic acid, 1.19 sodium hydrogen carbonate and

0.1 g anhydrous sodium sulphite in part freshly prepared

water for injection.


WVD

Date № Natrii sulfitis anhydrici 0,1

Acidi ascorbinici 2,5

Natrii hydrocarbonatis 1,19

Aquae pro injectionibus ad 50 ml

Vol = 50 ml

Sterilis

Prepared: Signature

Checked: Signature


Containers and closures

Injectable formulations are packaged into containers made of glass or plastic. Container systems include ampoules, vials, syringes, cartridges, bottles, and bags.


Packaging Components:

1. Primary components: Syringes , Ampoules ,

Flexible Bags, Bottles And Closures

2. Secondary components: Cartons and Overlaps

3. Associated components: Dosing Droppers And

Calibrated Spoon

Quality control

The finished parenteral products are subjected to the following tests, in order to maintain quality control:

A) Sterility test - Sterility is defines as freedom from the presence of viable microorganism

B) Clarity test - mobile insoluble matte (UK lamp)

C) Leakage test - Leakage tests are 4 types 1. Visual inspection 2. Bubble test 3.Dye tests 4.Vacuum ionization test

D) Pyrogen test - rabits

E) Assay Ph. - qualitative and quantitative determinations, uniformity of content, etc.


STERILE DOSAGE FORMS

(II) Lecturer – Dr. Cristina Ciobanu,

Associat Professor

Drug Technology Department

State University of Medicine and Pharmacy Nicolae Testemitanu

Content:

■ 1. Isotonisation of injectable solutions

■ 2. Perfusions

■ 3. Ophthalmic formulations

■ 4. Preparation of dosage forms of antibiotics

Dr. Cristina Ciobanu, SUMPh N. Testemitanu

INJECTIONS

■ Injections are the sterile solutions or suspensions of drugs in aqueous or oily vehicle meant for introduction into the body by means of an injectable needle under or through one or more layers of the skin or mucous membrane.

■ • Injections should be sterile, isotonic and free from foreign particles, such as dust, fibres etc.


OSMOSIS

■ Osmosis is the diffusion of solvent through a semi-permeable membrane.

– Water always flows from lower solute concentration [dilute solution] to higher solute concentration until a balance is produced

■ Osmotic pressure is the force that cause this diffusion .

■ Tonicity is a measure of the osmotic pressure of two solutions separated by a semi-permeable membrane.

■ Iso- osmotic solutions: solutions having same osmotic pressure.


GENERAL PRINCIPLES FOR ADJUSTMENT OF ISOTONICITY

1. Parenteral preparations should be isotonic with blood plasma (depending on the route of administration).

intravenous injection- isotonicity is always desirable.

Subcutaneous injection- not essential.

Intramuscular- hypertonic. iv.

Intrathecal injection- isotonic

2. Nasal drops- should be isotonic.

3. Ophthalmic preparations- should be isotonic.


Isotonic fluids

Aqueous solution of 0.9 percent sodium chloride, isotonic with the blood and tissue fluid, used in medicine in sterile form, as a solvent for drugs that are to be administered parenterally to replace body fluids.

Also called normal saline solution, physiological salt solution, physiological sodium chloride solution.


http://www.dictionary.com/browse/physiological-salt-solution






Advatages of isotonic

solution

CALCULATION FOR SOLUTION ISOTONIC

■ Some of the many ways;

■ 1. Freezing point depression method

■ 2. NaCl equivalent method

■ 3. White Vincent method

■ 4. Sprowl method

- 5. Molecules concentration method (Mendeleev-Claiperon):

■ 6. Graphical method on vapor pressure and freezing point determination


1. Mendeleev-Claiperon Ecuation:

■ m = 0,29 x M

■ where M-molecular weight of subst.


Example:

Rp: Sol. Glucosi isotonicae 100ml for injectionibus

D.S. For infusions.

0.29 x 180 = 52.2 g for 1000 ml

For the preparation of 1 l of isotonic glucose solution,

Mr = 180, it is necessary to take 52.2 g of glucose for 1 l

of solution:

and for 100ml -5.22g.

Thus, the isotonic concentration of the

glucose is about 5%.

■ F.P. of blood & tears = - 0.52º

■ Any solution have F.P. = - 0.52º is isotonic.

■ Any solution have F.P. › - 0.52º is hypotonic

■ - 0.4º hypotonic

■ -0.6º hypertonic

■ Add solute to hypotonic solution to reach f.p.d of blood (- 0.52º )

2. Freezing point depression (FPD)

cryoscopic method

1%----------- to

X---------------0,520,

= conc. gm/100 ml of adjusting substance

= f.p.d of 1% of unadjusted

d substance(table) X percentage strength

= f.p.d of 1% of adjusting substance (table)

t

w152.0

%

%w

1

t

■ Example

Determine the isotonic concentration of the novocaine solution (const.crisc = 0.1220).

■ Using the formula we obtain:

■ 1%----------- 0,1220o

X---------------0,520,

■ x = 0.52 0 x 1% = 4.26 = 4%

■ 0.1220

■ The isotonical concentration of the novocaine solution will be 4%


3. Na Cl isotonic equivalent

■ Calculation of isotonic concentration using

■ the isotonic equivalent of sodium chloride.

■ The isotonic equivalent of sodium chloride substances show the amount of NaCl that creates an osmotic pressure equivalent to 1.0g of drug substance.

■ In the DAN, the equivalents of NaCl are present

■ for the most widely used substances

■ drug.


■ Rp: Solutio Natrium thiosulfate 100ml

■ Sterilisetur!

■ D.S. For injections, 2 ml twice daily, intramuscularly.

■ We have a liquid drug form for use

■ injection. In this case, the concentration is unknown isotonic solution. But we are told from the table

■ E (NaCl) for sodium thiosulphate is = 0.3g.

■ 1.0 g of sodium thiosulfate - 0.3 g of NaCl

■ Xg sodium thiosulphate -------------- 0.9 g NaCl

■ X = 0.9 x 1.0 = 3.0 g sodium thiosulfate --- 3%

■ 0.3



Rp: Solutio Novocaini Hydrochloride 1% -100ml

Natrii chloridi q.s.

U.f.solutio izotonicae

Sterilisetur!

M.D.S. For injections.

It is (NaCl) of novocaine = 0.18.

1.0 ------------ 0,18g NaCl

1.0 g ------------ X g NaCl

X = 1.0 x 0.18 = 0.18g NaCl

For this solution to be isotonic you need to added 0.72 g

of NaCl.

0.9 - 0.18 = 0.72g

DRUGS WITH ANTIBIOTICS


■ Antibiotics - microorganisms that "kill" or prevents the growth of bacteria by helping the immune system to stop the infection.

■ All kinds of antibiotics work on the cell wall of the microbes that I destroy, which results in the bacterial cell disintegration.

■ They are wide-spectrum antibiotics (effective on many bacteria) and specific (effective on a single bacterial strain).

■ Antibiotics are indispensable in the treatment of certain diseases such as meningococcal meningitis, pneumonia, tuberculosis etc.

■ Anti-counter; bios; (opposed to life).


Antibiotic class Drug names

Penicillins

•Benzylpenicillin Benzylpenicillin

•Broad-spectrum penicillins Amoxicillin, ampicillin, co-amoxiclav

•Antipseudomonas penicillins Piperacillin, piperacillin plus tazobactam, ticaricillin

Cephalosporins

• First generation Cefalexin, cefradine, cefadroxil

• Second generation Cefuroxime, cefaclor, cefixime

• Third generation Cefotaxime, ceftazidime, ceftriaxone

Carbapenems and other β-lactams Ertapenem, imipenem, meropenem, aztreonam

Tetracyclines Tetracycline, demeclocycline, doxycycline,

lymecycline, minocylcine, oxytetracycline

Aminoglycosides Gentamicin, amikacin, tobramycin, neomycin

Macrolides Erythromycin, azithromycin, clarithromycin

Clindamycin Clindamycin

Sulphonamides and trimethoprim Co-trimoxazole, trimethoprim

Metronidazole Metronidazole

Quinolones Nalidixic acid, ciprofloxacin, norfloxacin, ofloxacin,

levofloxacin, moxifloxacin

Glycopeptides Vancomycin, teicoplanin

TB drugs Ethambutol, rifampicin, streptomycin

Others Chloramphenicol, daptomycin, sodium fusidate,

linezolid, nitrofurantoin


■ Preparation of antibiotic forms:

■ All antibiotic forms are prepared aseptically.

■ On release, the "aseptic" label is attached,

■ Keep it cool

■ They are prescribed as powders, suspensions, ointments, suppositories, nasal drops, injectable solutions, etc.

■ All antibiotics are thermolabile substances

■ (with the exception of levomicetine).


FACTORS AFFECT THE STABILITY OF MEDICINAL FORMS WITH ANTIBIOTICS:


light;

temperature;

medium’s pH;

microorganisms;

the rules for introducing the substances into the medicinal form;

OINTMENTS WITH ANTIBIOTICS

■ They are widely used in ophthalmic and dermatological practice.

■ Antibiotic used for preparing ophthalmic ointments is benzylpenicillin sodium, that it is ground in the presence of sterile vaseline oil used in a quantity of ½ of its mass;

■ Excipient used for preparing ophthalmic ointment: is anhydrous lanolin – vaseline “for ophthalmic ointments”;

■ As an excipient for dermatological practice Vaseline-Lanolin alloy will be used (ratio 4:6)

■ Rp: Ung. Eritromicini 1% - 10,0

■ D.S Ointment.

■ 0.1 g of Eritromicin are triturated in the sterile mortar with an amount of sterile excipient, heated tot-40 ° C

■ (4.0 g of lanolin and up to 10.0 g of vaseline);

■ Shelf life - 10 days.


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