The preparation is to meet the needs of treatment or prevention. The raw material is combined with various excipients, such as adhesives, antioxidants, excipients, and flavoring agents, and is made according to certain dosage requirements. Provide medicines to the subjects. In the research and development of pharmaceutical preparations, choosing the appropriate dosage form and preparation technology is the key to ensuring the efficacy of the drug, reducing adverse reactions, and improving medication compliance. The following points briefly describe the importance of dosage form selection in the entire drug formulation development:
(1) Changing the nature of the drug: If some drugs are made into liquid preparations, they are unstable due to hydrolysis, so solid dosage forms should be used.
(2) Adjust the speed of action of the drug: If some emergency patients require rapid drug effect, injections and aerosols should be used.
(3) Reduce adverse drug reactions: For example, erythromycin can be made into enteric-coated preparations to solve the problem of its decomposition in gastric acid and greater irritation.
(4) Improve the stability of the drug: choosing the dosage form according to the nature of the drug can improve the bioavailability of the drug.
(5) Improve the targeting effect of drugs: some dosage forms can play a targeting effect and reduce the side effects caused by systemic effects.
(6) Improve patient compliance: For example, the dosage form of medicine for children can be made into oral suspension or drops.
Generally speaking, the research and development of pharmaceutical preparations starts with pre-prescription research, doing some research on the raw materials, fully grasping the physical and chemical properties, pharmacology and pharmacokinetic properties of the drug, fully understanding its properties, determining the best route of administration, and formulating a Preparation prescription goals. Then it is faster and more efficient to use DoE to screen prescriptions. If necessary, a compatibility test of excipients is required, and then the research content is determined according to the dosage form and process flow. Appropriate tests, such as stability test, dissolution or release test, bioavailability test, etc., are conducted to investigate various quality indicators of the preparation; and the formulation and preparation process are improved, optimized or perfected based on the test results.
Medicilon provides drug preparation development services, including tablets, injections, capsules, granules, ointments, creams, sprays, gels, syrups, tinctures, oral liquid preparations and other preparation process research and quality research Commonly used equipment and instruments, as well as the GMP pilot plant for oral solid dosage forms , also have the ability to develop new technologies such as sustained and controlled release preparations, nano preparations, and fat emulsions.
Preparation is a discipline with a long history. For a long time, there was a proverb in China for medicines “Pill San Gao Dan, it is difficult to distinguish the gods”. Among them, “Pill San Gao Dan” refers to different dosage forms of pharmaceutical preparations.
Different dosage forms prepared to meet the needs of disease diagnosis, treatment or prevention, commonly used dosage forms include tablets, pills, powders, injections, tinctures, solutions, extracts, ointments, etc. When choosing the dosage form of the pharmaceutical preparation, the appropriate dosage form should be selected according to different routes of administration.
The main dosage forms of early Chinese medicines are: decoction, wine, cake, koji, bathing agent, pill, ointment and other different types. Since the second half of the 19th century, the formulation industry has developed into an independent field in drug production, and many new formulations have been developed such as tablets, sugar-coated tablets, enteric-coated tablets, film-coated tablets, injections, capsules, and suppositories. , Aerosols, medicinal films, and a variety of sustained-release and controlled-release formulations, targeted formulations and prodrug formulations.
(1) Sustained release preparations and controlled release preparations
Sustained-release preparation refers to a preparation that can continue to release the drug after administration to obtain a long-acting effect, which can increase the reaction time of the drug and reduce the side effects. Controlled-release preparations mainly refer to preparations in which the drug can be automatically released at a predetermined speed within a preset time, so that the blood concentration is stable for a long time within a reasonable concentration range, thereby achieving the effect of reducing toxic and side effects.
(2) Targeted preparation
Targeted formulation is a drug delivery system based on the carrier that allows drugs to selectively aggregate at the location where the disease occurs. Effective targeted formulations include four elements: positioning, concentration, controlled release, and non-toxic and biodegradable. Targeted preparations facilitate the exertion of drug effects, enhance drug effects, reduce toxicity, improve the safety and reliability of drugs, and the compliance of patients with medication.
(3) Prodrug preparations
Prodrug preparation refers to a new type of compound produced by fusing a parent drug that exhibits pharmacological activity with other types of carrier genes (or combining with another parent drug with similar effects), and then through biotransformation Enzymes or other biological functions can release the parent drug and exert its effect. It can achieve the purpose of sustained-release drug resistance, and can improve the shortcomings of lack of stability of the drug, poor absorption, and great irritation.
In terms of preparation production and pharmaceutical packaging, it has gradually developed from manual operation to semi-mechanized, mechanized, semi-automated and fully automated.
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