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The application of the sample is repeated until the filter paper disks applied to the test area no longer absorb the ointment. Then the amount of unresorbed drug contained in the paper is determined. The amount of drug that has penetrated the skin is determined by the remaining difference. Histologic studies with the help of a microscope allow to determine which layer of the skin the preparation has reached. The ointment is applied to a depilated area of the animal’s skin, then, after slaughtering it, histologic sections are made, which may be longitudinal (to determine the depth of penetration) or transverse (to evaluate the area of ointment distribution). Determination of drugs resorbed in blood, organs and tissues, secretions, or exhaled air after topical application of the ointment.
4Registration of biological or toxic reactions caused by the drug (pupil reaction, change in pain sensation, heart rate, onset of convulsions or death, etc.).
Radioisotope method using labeled drugs. Both in vitro and in vivo methods give relative results. While the former should be viewed critically on the grounds that they do not take into account the physiological functions of the skin, the latter give only approximate results, since human skin both in terms of function and structure differs significantly from animal skin. Only clinical tests can give the final assessment of the ointment. In addition to the above-described quality indicators of ointments, which are controlled before packing, after the completion of the entire production process should control the mass of the contents of the package, which should not be less than the mass indicated on the label. Deviation in the mass of ointments or creams, packaged in tubes or jars, checked by weighing ten samples. For sterile and non-sterile ointments, creams and other soft drugs should be carried out to determine the tightness of packaging in accordance with the following methodology. Take 10 tubes with the drug and thoroughly wipe their outer surfaces with filter paper. The tubes in a horizontal position are placed on a sheet of filter paper and kept in the thermostat at a temperature of 60±3 ° C for 8 hours. There should be no drips of drug from any tube on the filter paper, ignoring any traces of drug initially on the threads of the cap and tube. If leakage is observed from only one tube, the test shall be carried out with an additional 20 tubes. The results of the test shall be considered satisfactory if no leakage is observed from the first ten tubes or if leakage is observed for only one of the thirty tubes.
Pharmaceutical Glossary
Technical specifications
The degree of dispersibility in emulsion ointments and creams is determined under the condition of coloration of the dispersed phase. The diameter of 1000 droplets is determined and then the percentage of droplets of different sizes is calculated. The method is easy to perform, but quality standards for emulsion creams and ointments are not yet specified in any pharmacopoeia. Determination of pH of ointments is necessary to monitor the behavior of drug substance and base during storage. A shift in pH indicates a change in their physicochemical properties. To determine the pH of ointments and creams suspended product poured 50 ml of distilled water with a temperature of 50-60 “C and shaken on a vibrator for 30 minutes. The resulting extract is filtered and conducted potentiometric titration according to the method of GF. All ointments produced by pharmaceutical companies, have a guaranteed shelf life, during which, if properly stored, they should remain stable. The stability of ointments is determined by the unchanged content of drug substances (within the established tolerance), structural properties and the rate of release of drugs. Stability testing of ointments is particularly essential if they are emulsion systems. One acceptable technique for testing the stability of such ointments is the colloidal stability methodology. Assessment of colloidal stability of a cream or ointment is carried out on a centrifuge at a speed of 6000 rpm for 5 min. Under the influence of centrifugal force, the emulsion breaks down the faster; the less stable it is. The absence of stratification of the product sample indicates the stability of the composition. Thermal stability of the product is determined by heating the ointment or cream in a desiccator at 60 ° C for 1 h. If the product is qualitative, the sample should remain homogeneous without stratification. Sometimes in ointments and creams it is necessary to determine the structural and mechanical properties (ultimate shear stress, which characterizes the strength of the structure and consistency of ointments, and plastic viscosity, which characterizes the flow of the system with a destroyed structure), the degree of release of drug substances from the preparation and the stability of the product under different storage conditions. These determinations are usually made when developing new ointments and creams or improving existing ones. The consistency of ointments and ointment bases requires objective evaluation, as it affects the processes of their preparation and packaging, the ease of application of ointments to the skin and the release of drug substances from them. One of the main factors on which the consistency of ointments depends is the ultimate shear stress. It characterizes the ability of ointments to provide some resistance to smearing, the ability to squeeze out of tubes, dispensers, etc. The ultimate (or critical) shear stress is the force in dynes acting on an area of 1 cm2 tangentially to the plane of displacement and causing irreversible deformation of the system.
Additional information
The ultimate shear stress is also called the flow point, meaning the stress required for the system to start flowing (for irreversible deformation). The higher the value of this value, the more difficult the ointment is to spread. This is an important characteristic of ointments and ointment bases because it determines the ease of application of ointments. Usually a Volarovich rotary viscometer or a conical plastometer is used to determine the ultimate shear stress. Plastic viscosity, another important rheological characteristic of ointments and ointment bases, is determined on a Volarovich rotary viscometer RV-8. The degree of release of drug substances is a criterion for assessing the quality of ointments, which should become the main criterion for standardization and rejection (verification of compliance of the product quality with the requirements of the standard) of ointments. Methods for determining the degree of drug release in vitro and in vivo have been developed. In vitro methods. The technical performance of experiments by in vitro method can be different and is mainly determined by the properties of the included drugs. Direct diffusion method. In this case, the ointment sample must be in direct contact with the medium into which the drug substance diffuses. Method of diffusion through the membrane. The essence of the method is that the ointment under study is separated from the aqueous medium by a semipermeable membrane. This can be cellophane or lipoid membranes of animal origin, such as egg shells, a section of intestine or animal skin. The dialysis media are aqueous solutions or water. The apparatus design of these studies can vary. In recent years, there have been many installations that maximally approximate the conditions of experience to the conditions of a living organism. Most often these are two-chamber installations separated by membranes or membrane systems. One of the chambers contains the ointment and the other contains the dialysis medium. Despite the design differences, the setups obey the same principle and reflect the same dependencies. In vivo methods. In contrast to in vitro methods, these methods allow two processes to be assessed at once: the ability of the ointment base to release the active ingredients and the degree of resorption of the active ingredients through the skin. In vivo methods include the following studies: Determination of the resorbed amount of drugs by the difference between the applied ointment sample and the non-absorbed portion of the ointment. Such evaluation is acceptable on both animal and human skin. A certain amount of ointment is applied and rubbed evenly on a strictly limited area of skin using a template. A pressure of 100 mmHg is applied to this area using a cuff.
Order status tracking
Hello, I will quickly ask, what about BG-80 film coating boiler and HX-7 ultrasonic machine for sealing plastic tubes, contract No. 11 ???? 29/10/2024 12:21
Benjamin, good afternoon! Your positions are produced by different factories, for HX-7 the factory reported that it is 90% ready, for BG-80 we are waiting for an answer as stipulated in the contract. We will report back immediately. 29/10/2024 12:25
Vacuum lyophilic freeze dryer LG-30, can we get faster than the contract ? 29/10/2024 12:31
Hello Ethan, Shipments go through several time stages. Manufacturing, delivery from the factory to the warehouse in Beijing or Shanghai, waiting for batch collection, customs clearance and delivery. It's hard to predict. 29/10/2024 12:34
Dear Roman. Deadline (time) I am waiting for your quotation for a machine for removing tablets and capsules from blister packs MB-10 with delivery. 29/10/2024 12:41
Hello Sebastian, By the specified time we will send the offer to your e-mail. Now we are waiting for an answer from the transportation company on the delivery time to Cleveland . 29/10/2024 12:43
Dear Roman, how are you doing? Our company bought more than a year ago a filling and capping machine for penicillin vials, model XL-10. We got financing this year and want the same machine. Will you give us a discount? 29/10/2024 12:51
Carter, thank you. We're doing great. Of course we will give a discount to the regular customer. Delivery of equipment also in Las Vegas ? Contact Natalia, she will send the contract and invoice. 29/10/2024 12:54
PU-420 flow-pack packaging machine along with 500 kg packaging , delivery to Orora. Please confirm the delivery time. 29/10/2024 13:01
Good afternoon Leah, your shipment has left. Arrival time tomorrow until 12:30. The driver will call you back later. Please organize prompt unloading. 29/10/2024 13:04
In Split ITA-01 tablet and capsule counter, RZ-9 rotary tablet press and manual capsule filling machine. Help when we get it ? 29/10/2024 13:11
Good afternoon, Sofia! We have received from the factories photos of the equipment after packing. Natalia will forward the photos to you. Delivery time to you is 45-50 days. 29/10/2024 13:15
Hello Roman! Thank you for the service and quality of your products. We are very happy and satisfied with the purchase! 29/10/2024 13:21
Hello Emma, Apparently you have tested your vacuum lyophilic dryer LZY-01. Its quality is above average, it will work. We are waiting for your new applications. 29/10/2024 13:23
PU-420 flow-pack packaging machine along with 500 kg packaging , delivery to Bakersfield. Please confirm the delivery time. 29/10/2024 13:31
Good afternoon Lily, your shipment has left. Arrival time between 12:00-14:00. The driver will call you back later. Please organize prompt unloading. 29/10/2024 13:32
For shipping to Bucharest do you have to pay anything extra ? 29/10/2024 13:41
Good day James, In our catalog, all prices are inclusive of shipping to the customer's door. Delivery to Bucharest is included. 29/10/2024 13:44
Good afternoon, we received the PR-15 powder dispenser in plastic vials, scheduled in the interval from 10:00-12:00 to open the box and test. 29/10/2024 13:51
Dylan, good afternoon. Great news, please send a photo and video report to WhatsApp +79853643808. 29/10/2024 13:55
- AUTOMATIC EQUIPMENT FOR REMOVING TABLETS AND CAPSULES FROM BLISTERS
- EQUIPMENT FOR FILLING AND SEALING GLASS AMPOULES
- EQUIPMENT FOR PACKING POWDERS INTO VIALS
- EQUIPMENT FOR THE PRODUCTION OF TABLETS
- EQUIPMENT FOR PRINTING LOGO ON TABLETS AND CAPSULES
- EQUIPMENT FOR FILLING HARD GELATIN CAPSULES WITH POWDER
- MACHINES FOR THE PRODUCTION OF SUPPOSITORIES
- EQUIPMENT FOR COUNTING AND PACKAGING TABLETS AND CAPSULES IN BOTTLES
- HIGH-PRECISION DOSING MACHINES POWDER FILLING MACHINES
- EQUIPMENT FOR PACKAGING TABLETS AND CAPSULES IN PLASTIC BOTTLES
- MACHINES FOR FORMING AND FILLING PLASTIC AMPOULES
- BOTTLE FILLING AND CAPPING EQUIPMENT
- EQUIPMENT FOR WASHING AND STERILIZING BOTTLES
- SPRAY DRYING EQUIPMENT FOR SUSPENSIONS
- EQUIPMENT FOR COATING TABLETS
- EQUIPMENT FOR POLISHING AND DEDUSTING TABLETS AND CAPSULES
- EQUIPMENT FOR FILLING CREAMS AND SEALING PLASTIC TUBES
- POWDER GRANULATION EQUIPMENT
- EQUIPMENT FOR HOMOGENIZING CREAMS AND OINTMENTS
- EQUIPMENT FOR SCREW FEEDING OF POWDERS
- EQUIPMENT FOR EFFICIENT MIXING OF POWDERS
- EQUIPMENT FOR AUTOMATIC BOTTLE FEEDING FOR FILLING LINES
- EQUIPMENT FOR VACUUM TRANSPORTATION OF POWDERS
- AUTOMATIC PHARMACEUTICAL CENTRIFUGES
- EQUIPMENT FOR METAL DETECTOR IN GELATIN CAPSULES AND TABLETS
- EQUIPMENT FOR PACKAGING BULK MATERIALS IN PLASTIC BAGS
- EQUIPMENT FOR FILLING AND PACKAGING HERBAL TINCTURES
- EQUIPMENT FOR APPLYING THE EXPIRATION DATE AND BATCH NUMBER TO PRODUCTS
- EQUIPMENT FOR VACUUM PACKAGING IN PLASTIC BAGS
- EQUIPMENT FOR FILLING LIQUIDS IN PLASTIC AND METAL BARRELS
- EQUIPMENT FOR PACKAGING PRODUCTS IN A FLOW PACK
- EQUIPMENT FOR WRAPPING CARDBOARD BOXES WITH CELLOPHANE
- FLOW-PACK PACKAGING MACHINES
- EQUIPMENT FOR THE MANUFACTURE AND PACKAGING OF WET ALCOHOL WIPES
- AUTOMATIC CARTONING MACHINES
- EQUIPMENT FOR PACKAGING FOOD PRODUCTS IN DOY-PACK PACKAGES
- EQUIPMENT FOR PACKAGING TABLETS IN STRIPS AND TUBES
- EQUIPMENT FOR PACKING TEA INTO TEA BAGS WITH THREAD AND LABEL
- AUTOMATIC EQUIPMENT FOR SELF-ADHESIVE LABELS ON PACKAGING
- AUTOMATIC EQUIPMENT FOR BLISTER PACKAGING
- EQUIPMENT FOR INDUCTION SEALING OF ALU FOIL BOTTLES
- EQUIPMENT FOR WEIGHT CONTROL AND SORTING OF CARDBOARD BOXES WITH MEDICINE
- DESKTOP EQUIPMENT FOR LIQUID DOSING
- EQUIPMENT FOR LABORATORY TESTING OF MEDICINES
- SEMI-AUTOMATIC EQUIPMENT FOR BLISTER PACKAGING
- EQUIPMENT FOR VIBRATING SIEVING OF POWDERS
- EQUIPMENT FOR MIXING LIQUIDS WITH MICROWAVE HEATING
- EQUIPMENT FOR POWDERING PHARMA RAW MATERIALS
- EQUIPMENT FOR THE PRODUCTION OF FISHING BOILIES
- MANUAL EQUIPMENT FOR FILLING GELATIN CAPSULES WITH POWDER
- DESKTOP EQUIPMENT FOR HIGH-SPEED EMULSION PRODUCTION
- SEMI-AUTOMATIC EQUIPMENT FOR FILLING GELATIN CAPSULES
- DESKTOP EQUIPMENT FOR MIXING POWDERS
- MACHINES PRINTING EXPIRATION DATE AND LOT NUMBER
- EQUIPMENT FOR AUTOMATIC DOSING OF CREAMS AND OINTMENTS
- PERISTALTIC PUMPS DISPENSERS
- EQUIPMENT FOR WASHING AND STERILIZING BOTTLES
- SPRAY DRYING EQUIPMENT FOR SUSPENSIONS
- EQUIPMENT FOR PRINTING LOGO ON TABLETS AND CAPSULES
- BOTTLE FILLING AND CAPPING EQUIPMENT
- EQUIPMENT FOR COUNTING AND PACKAGING TABLETS AND CAPSULES IN BOTTLES
- HIGH-PRECISION DOSING MACHINES POWDER FILLING MACHINES
- EQUIPMENT FOR FILLING CREAMS AND SEALING PLASTIC TUBES
- EQUIPMENT FOR FILLING HARD GELATIN CAPSULES WITH POWDER
- EQUIPMENT FOR THE PRODUCTION OF TABLETS
- AUTOMATIC EQUIPMENT FOR REMOVING TABLETS AND CAPSULES FROM BLISTERS
- EQUIPMENT FOR PACKAGING TABLETS AND CAPSULES IN PLASTIC BOTTLES
- EQUIPMENT FOR PACKING POWDERS INTO VIALS
- EQUIPMENT FOR COATING TABLETS
- MACHINES FOR FORMING AND FILLING PLASTIC AMPOULES
- EQUIPMENT FOR POLISHING AND DEDUSTING TABLETS AND CAPSULES
- EQUIPMENT FOR FILLING AND SEALING GLASS AMPOULES
- MACHINES FOR THE PRODUCTION OF SUPPOSITORIES
- AUTOMATIC PHARMACEUTICAL CENTRIFUGES
- EQUIPMENT FOR EFFICIENT MIXING OF POWDERS
- EQUIPMENT FOR HOMOGENIZING CREAMS AND OINTMENTS
- EQUIPMENT FOR AUTOMATIC BOTTLE FEEDING FOR FILLING LINES
- EQUIPMENT FOR VACUUM TRANSPORTATION OF POWDERS
- POWDER GRANULATION EQUIPMENT
- EQUIPMENT FOR SCREW FEEDING OF POWDERS
- EQUIPMENT FOR THE MANUFACTURE AND PACKAGING OF WET ALCOHOL WIPES
- EQUIPMENT FOR PACKAGING FOOD PRODUCTS IN DOY-PACK PACKAGES
- EQUIPMENT FOR WEIGHT CONTROL AND SORTING OF CARDBOARD BOXES WITH MEDICINE
- EQUIPMENT FOR APPLYING THE EXPIRATION DATE AND BATCH NUMBER TO PRODUCTS
- FLOW-PACK PACKAGING MACHINES
- EQUIPMENT FOR VACUUM PACKAGING IN PLASTIC BAGS
- EQUIPMENT FOR PACKAGING BULK MATERIALS IN PLASTIC BAGS
- AUTOMATIC EQUIPMENT FOR SELF-ADHESIVE LABELS ON PACKAGING
- AUTOMATIC EQUIPMENT FOR BLISTER PACKAGING
- EQUIPMENT FOR INDUCTION SEALING OF ALU FOIL BOTTLES
- AUTOMATIC CARTONING MACHINES
- EQUIPMENT FOR WRAPPING CARDBOARD BOXES WITH CELLOPHANE
- EQUIPMENT FOR FILLING LIQUIDS IN PLASTIC AND METAL BARRELS
- EQUIPMENT FOR PACKAGING TABLETS IN STRIPS AND TUBES
- EQUIPMENT FOR FILLING AND PACKAGING HERBAL TINCTURES
- EQUIPMENT FOR PACKING TEA INTO TEA BAGS WITH THREAD AND LABEL
- EQUIPMENT FOR METAL DETECTOR IN GELATIN CAPSULES AND TABLETS
- EQUIPMENT FOR PACKAGING PRODUCTS IN A FLOW PACK
- DESKTOP EQUIPMENT FOR LIQUID DOSING
- SEMI-AUTOMATIC EQUIPMENT FOR FILLING GELATIN CAPSULES
- DESKTOP EQUIPMENT FOR HIGH-SPEED EMULSION PRODUCTION
- DESKTOP EQUIPMENT FOR MIXING POWDERS
- MANUAL EQUIPMENT FOR FILLING GELATIN CAPSULES WITH POWDER
- EQUIPMENT FOR AUTOMATIC DOSING OF CREAMS AND OINTMENTS
- EQUIPMENT FOR LABORATORY TESTING OF MEDICINES
- EQUIPMENT FOR POWDERING PHARMA RAW MATERIALS
- SEMI-AUTOMATIC EQUIPMENT FOR BLISTER PACKAGING
- PERISTALTIC PUMPS DISPENSERS
- EQUIPMENT FOR VIBRATING SIEVING OF POWDERS
- MACHINES PRINTING EXPIRATION DATE AND LOT NUMBER
- EQUIPMENT FOR THE PRODUCTION OF FISHING BOILIES
- EQUIPMENT FOR MIXING LIQUIDS WITH MICROWAVE HEATING