Zhang ting-ho (professor, chengdu university of medicine)
The treatment of paediatric diseases in chinese medicine is effective and has small side effects, but there are disadvantages such as poor taste, poor suitability of the agent and low responsiveness of children to medication. The number of drug symbols approved for listing in our country is low for children and even lower for children. How to make paediatric drugs more suitable for use by children is key to promoting innovative research and development for drug improvement among children。
Key to policy encouragement and improvement
The state attaches great importance to the development of paediatric medicines and has gradually developed a system of policy support. In 2019, the medicines management act was amended to provide “support for the development of new varieties, formulation types and specifications of children's medications that correspond to their biological characteristics”. In 2020, the newly revised drug registration management scheme included children's medicines in the priority review approval process. In november 2023, the first medium drug, type 2. 2, of a new, modified form of accelerator, was introduced into the market, and the granules were replaced with a slurry agent, which reduced the bitterness and significantly increased the dependence of children on medication. In may 2024, the cde published the technical guidelines for research on improved medicines in chinese medicines (preliminary) which propose as a priority orientation, based on dependent improvements, to encourage the development of new formulations for specific groups of the population, such as those with difficulty of swallowing; and to encourage the development of new formulations for children that are consistent with their developmental characteristics and drug habits. In november 2024, the office of the state council issued a number of measures to accelerate the improvement of the system of reproductive support policies to promote the construction of a productive and friendly society, which explicitly called for “enhancement of the cost of medical care for children and the timely incorporation of eligible children's medications into the health insurance reimbursement system”. Encouraged by the policy dividend, pharmaceutical companies have deployed drug-enhanced innovative tracks among children。
In the view of the writer, oral and swallowable dual-opportunity designs are key points of innovation in drug improvement among children. Chinese medicine is prevalent in the form of mild, acidic or spicy tastes. More than 240 children in the chinese pharmacy are exclusively used or shared among adults. The ingestion function of children is not yet fully developed and traditional pills, tablets, capsules, etc. Are of a larger size and are difficult for children to swallow. Therefore, attention to the physical characteristics of the child and improvement of the mouthworthiness and osmosis of the formulation are important goals of innovation in drug improvement among children, in the context of guaranteeing clinical efficacy. It also points the technical direction for “where” and “how to change” new improved medicines。
In combination with advances in the development of pharmaceutical habits and existing innovative types of drugs, the author provides recommendations for optimizing the pharmaceutical-type improvements among children for peer reference。
Oral fluids, combinations, exploring oral gel
The chinese oral liquid and combinations are the main child medicine type and are easy to swallow, but they are difficult to correct because of the high dispersion of the odour-based substances in molecular or adhesive form, the use of instant irritating buds, the full exposure of the taste, the poor taste. Oral gel is a semi-fluent formulation of oral delivery. As a special “soft matter”, the mobility of liquid formulations is similar to that of swallowing, and the unique semi-coercive system, which combines protein, sugar and synthetic molecules to form a three-dimensional network structure, limiting the spread of tasteful substances and creating micro-environments conducive to odor。
At present, oral gel has been collected in the korean pharmacy and the japanese pharmacy. Although the current edition of the chinese pharmacy has not yet been incorporated into the general code of formulations, chinese western medicine is available on the market for oral gels, such as oral gel gels for oral gels in children, gels for oral gels for acetaminophenol and gels for 2-dimensional fish livers。
The key to innovative design of oral gel in chinese medicine is the choice and application of the type of gel adjoining material that is masked. In addition, how to optimize the formulation, and how to balance the combination of osmosis and osmination performance, is an important element of formulation design. For example, yellow-coloured bioalkalin odours are strong and conventional methods have limited corrective effect. The study found that karag had a special effect on the bitter taste of bioalkaline, that 1. 5 per cent of karagow use had reduced the yellow-coloured bitterness of clinical use by about 87 per cent, from extreme suffering to slight suffering; and that the combination of kalagut and cedar had resulted in a significant increase in the responsiveness of the administration through the production of yellow-coated oral gels with good ostrich and low mechanical strength。
Scatters, granules converted to oral velocity
It is larger than the surface area, more dispersed, exposed to various odours, strong sand and gravel, often requiring a large amount of drinking water and less acceptable to patients. The chinese particle agent is generally taken after melting with hot water, and the various odour-bearing substances are fully dissolved and exposed, to the detriment of odor. In november 2023, the first of the new chemicals of class 2. 2 - the direct bromosortium hydrochloride - - was approved for public production, with a sweet taste, a dissolved entrance, no need for water, a direct ingestion, the non-release of drugs in the mouth, the effective cover-up of bad tastes, and the solution to the problem of children's difficulties in taking medication. Innovative applications based on oral quick solution provide useful ideas for improved innovation in chinese bulk and particulate agents。
The key to the innovative design of china's oral velocities and fast-solving particles is the use of powder structure design and fast-solving auxiliary applications to achieve the formulation's “insolvency and fast-solving” in the mouth. For example, the golden bulk inside the chickens of the child has a stink and bitter smell that is unique to the insides of the chickens and is strong in sand and gravel. The study found that, by disrupting the proliferation perception of the odour of gold in chickens by using chinese pharmacological oscillation techniques and concealing their bitter tastes, a combination of fast-solving aids and preparation techniques can lead to the rapid disassembling of the gold in the chickens of the pediatric compound to “acoustic quick solution without water” and to rapid melting in about 10 seconds to become a child-friendly formulation。
The powder of the tablets is in the form of a microcyst at speed
While tablets are also one of the more common types of children's medicines, children are at risk of culverting the tablets, and parents often turn them into powders, delivering them with sugar, juice, etc., which destroys the tablets, exposes the bitter taste of the drugs to water and often leaves the senses of the medicine in a mild state. The application scenario based on a chinese tablet study for end-use can be modified to a new form of quick-condensation microscule to achieve the formulation purpose of powder “insoluble in water, smooth in the mouth and undisturbed in the stomach”。
Quick-condensation microbage is a completely new powder-forming technique that covers the surface of a drug powder, glacial powder material in the event of a water encounter, which quickly becomes a gel barrier layer, wraps the drug powder in order to form a gel microblade, hinders the release and exposure of the drug component and achieves the goal of oscillation. After entering the stomach, the gel material rapidly degrades and releases drugs. Quick-condensed microcysts can be used either directly in powder form or by crushing or filling capsules, which can also be used by front shredding or opening capsules. For example, the technology is used to prepare 3 or 7 total soap-based microcysts, which, when taken with water, can rapidly form a gel layer on the surface of the drug, hinder the melting of the 3 or 7 bitter ingredients, have almost no residues in the mouth, and rapidly degrade the release of the drug into the stomach for the purpose of improved innovation。
Concluding remarks
Improved innovation in medicine among children is both a policy-oriented industrial upgrading and a scientific breakthrough in technology. Among the many subdivisions of new and improved medicines, the best-fitting drug demand for children and the most promising are innovative agents. The research and development projects of pharmaceutical enterprises need to avoid the inertial thinking of changing “agent-type swaps” to “modify” and, through the introduction of new formulations, to truly address the oral and swallowable pain points of children's drug use, to satisfy unsatisfied clinical values, to promote the cross-cutting development of chinese medicine for children and to contribute to the global child health “china programme”。
Transferred from medical economy, no. 15, 2025
