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Carrier Materials and Applications of Solid Dispersions In solid dispersions, the rate of dissolution of the drug is highly dependent on the nature of the support and the manufacturing process. The requirements for the carrier are: water-soluble, physiologically inert, non-toxic; does not chemically react with the drug, does not affect the chemical stability of the main drug; easily makes the drug disperse in a good state; the source is easy and the cost is low.
At present, in the solid dispersion technology, the carriers commonly used in zui are water-soluble, poorly soluble, enteric, and other parts.
1. Water-soluble carrier materials For the preparation of immediate-release solid dispersions, water-soluble carriers are often used. Commonly used are: polyethylene glycol (PEG), polyvinylpolypyrrolidone (PVP), ploxacin 188 (pluronic F68), organic acids , sugars and alcohols. The PEG-based solid dispersion is mostly prepared by a melt method. First, the PEG is heated and melted, and then the drug is dissolved therein, and the melt is rapidly cooled after being uniformly stirred.
In a fusion method, serajuddin or the like first melts PEG at a temperature higher than 2 ° C above the melting point, and then melts the drug therein. The drug-containing carrier solution is poured into a hard gelatin capsule at room temperature to be solidified. In artificial gastric juice, the capsule shell is firstly Dissolved, the contents remained in a solid state and slowly dissolved according to the principle of dissolution. The solid surface drug dissolves to form an oily layer, delaying the further dissolution of the drug, and has a sustained release effect. In general, the dissolution rate of the drug mainly changes according to the molecular weight of the PEG. As the molecular weight of the PEG increases, the dissolution rate of the drug is The trend of gradual decline. Zui has recently reported that B-cyclodextrin (B-CD) derivatives can be used as a carrier for solid dispersions, in which 2-hydroxypropyl B-CD (2HP-B-CD) is very soluble in water (750g/ L), and has good biosecurity. Nagarsenker et al. prepared a solid dispersion of ketorolac using 2HP-B-CD and B-CD as carriers. The results of in vitro experiments showed that 2HP-B-CD significantly increased the release of ketorolac than that of B-CD.
Kirnura et al. prepared a solid dispersion of tolbutamide with 2HP-B-CD and PVP as carriers. The in vitro results showed that the release of solid dispersion prepared with 2HP-B-CD as carrier was significantly faster than that with PVP. The solid dispersion, the beagle dogs experiment is consistent with the in vitro experiment, and the absorption rate and the hypoglycemic effect are obviously improved. Yan et al. prepared a nifedipine-PEG 600 (1:6, w/w) steroid dispersion by melt method, and then used high viscosity HPMC (Methocel kl5m) and low viscosity HPMC (Methocel kl00) as the sustained release matrix material. Preparation of multilayer tablets, the ratio of the outer layer of high viscosity HPMC to drug is 1:2 (w / w); the ratio of inner layer low viscosity HPMC to drug is also 1:2 (w / w), the ratio of inner and outer weight is 7:3, mixed and pressed into tablets.
The in vitro release mechanism of the tablet is a combination of dissolution and diffusion, and the in vitro release has a good correlation with the cumulative absorption in the body (Y = 0.8635). The results of the animal test (beagle dogs) show: the film and the pair of photos (Adalat GITS 30) Compared with its bioavailability, it increased by 2.76 times, and the therapeutic blood concentration was maintained for 24 hours. Kohri et al. used HPMC and its hydroxg propyl methyl cellulos phthalate (HPMCP) as a carrier to prepare a solid dispersion of the anthelmintic albendazole. The dissolution rate was significantly accelerated, and the granules prepared therefrom were given. Rabbits are more than three times more bioavailable than their physical mixture after oral administration.
2. Poorly soluble carrier The poorly soluble carrier is a commonly used material for the preparation of slow release solid dispersions, including ethyl cellulose (EC) and Eudragit E, RL, P. S and lipid materials. The EC solid dispersion is usually prepared by a solvent evaporation method, and the drug and the EC are dissolved or dispersed in an organic solvent such as ethanol, and the solvent is evaporated and then dried. Najib et al. prepared an EC solid dispersion of sulfadiazine by this method. In vitro dissolution tests showed that the drug in this solid dispersion was released by zero-order kinetics. Khanfar et al. reported the preparation of a solid dispersion of sustained-release indomethacin using EudrgitRs as a blocker and sodium dodecyl sulfate (SLS) as a release regulator. Chen et al. used Eudragit RL as a carrier to prepare a suspension of misoprostol sustained-release granules by ethanol solvent evaporation method, and then used the granules to form tablets. The in vitro experiments showed that it had a significant sustained-release effect and also greatly improved. The stability of misoprostol.
3. Enteric Carriers Enteric carriers generally use cellulose acetate phthalate (CAP), hypromellose phthalate (HPMCP), polypropylene resin (Eudragit L, Eudragit S) and the like. Hasegawa et al. Zui prepared a solid dispersion of nifedipine using an enteric material such as HPMEP as a carrier. Gao Qiao Baozhi et al. prepared a solid dispersion of diisopropylpyramine and several enteric materials by spray drying method, in which the solid dispersion of drug-EC- HPLC P (1:1:2) has a good retardation. Release effect. Liu Shankui et al. used II No. 2 acrylic resin as carrier and added polyethylene glycol (PEG) as porogen to prepare an enteric solid dispersion of nicardipine hydrochloride, which achieved enteric dissolution and sustained release in PH6.8 buffer. The dissolution rate at 10h was 48.36%.
4. other:
Abd-Ei-Baryt et al. found in the study of solid dispersions of ketoprofen, B-cyclodex-trill, B-CD and lactose can also be used as carrier materials for solid dispersions to improve drug dissolution. In recent years, the synthetic metabolite Carbomer has been used more and more for bioadhesive and slow release matrix materials because it dissolves rapidly in water and does not dissolve. Ozeki f201 and other carbomers with different cross-linking degrees were mixed with polyoxyethylene (PEO 35000) to prepare a phenacetin controlled-release solid dispersion. The results showed that the release of the drug and carbomer The degree of cross-linking is related to the fact that the lower the degree of cross-linking, the more pronounced the sustained-release effect. According to this, the degree of cross-linking of carbomer can be used to regulate the drug release rate.
Solubilization mechanism and function characteristics of solid dispersion
1. Solubilization mechanism For poorly soluble drugs (solubility <0.1 mgin1), the first problem to be solved by increasing drug absorption is to increase the dissolution rate of the drug. By Noges-W Hitney equation dc/dt=K. S. C (where dc/dt is the dissolution rate of the drug, K is the dissolution rate constant, s is the surface area of ​​the drug, and c is the solubility of the drug). It is known that the dissolution rate of the drug is proportional to the surface area, solubility, and dissolution rate constant of the drug. Increasing the dissolution rate of the drug can be solved by increasing the solubility of the drug (stirring speed, temperature, properties of the medium, etc.) and increasing the surface area of ​​the drug (particle size, etc.). The solid dispersion is precisely because the carrier inhibits the tendency of the particles to be highly dispersed by the solid dispersion method to be aggregated (inhibiting the crystallinity), and the surface area is enlarged; in addition, the carrier itself promotes the dissolution of the drug, so the solubility of the solid dispersion is greater than that of the original drug. Improve, improve its dissolution rate, and promote drug absorption and bioavailability.
2. Characteristics of Solid Dispersion 1 For poorly soluble drugs, they can be dispersed in a carrier in different states (molecular, colloidal, amorphous, microcrystalline, etc.), and their solubility and dissolution rate are greatly improved, thereby improving drug absorption and bioavailability.
2 For small doses of drugs, they can be evenly dispersed in the carrier, which is easy to take, and the uniformity is easy to control, so that the medicine is safer.
3 For volatile liquid and gaseous drugs, it can reduce waste caused by volatilization, reduce cost and facilitate storage.
4 For drugs with poor stability, the solid dispersion can improve the stability of the drug and facilitate the quality control of the preparation.
5 For different drug purposes, different carriers can be used to prepare different dosage forms such as controlled release, sustained release and enteric dissolution.
Conclusion The development of solid dispersion technology is a new topic in pharmaceutics research. Both water-soluble drugs and poorly soluble drugs can be prepared into solid dispersions, which can be prepared into various dosage forms for different purposes. However, due to preparation The amount of carrier used in the process is large, so it is more suitable for small doses of drugs; in addition, the aging phenomenon of carrier materials is also a problem that cannot be ignored. Therefore, in future research, the application of new carrier materials and hybrid carriers will be developed to explore new ones. The preparation method and the development of solid dispersion more application methods are the active exploration direction of the majority of pharmaceutical workers; with the in-depth study of solid dispersions, it will have a broader application prospect in the field of pharmacy.
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Application of Solid Dispersion Technology in the Study of Pharmaceutical Preparation
A solid dispersion is a preparation technique for dispersing a drug in a highly dispersed state of Solid Dispersions (SDS) by a melt method, a coprecipitation method or a melt-solvent method in a carrier which is not physiologically active or easily soluble in water. . This technique was first proposed by Sekiguchi et al. in 1961, and a solid dispersion of sulfathiazole was prepared by a melt method using urea as a carrier. The experimental results show that after oral administration of this solid dispersion, its absorption and excretion are increased compared with oral sulfamethoxazole alone, which changes the water solubility and bioavailability of poorly soluble drugs. Since then, extensive studies have been conducted on solid dispersions. Its purpose is to change the solubility of poorly soluble drugs and to prepare highly effective and quick-acting preparations. In recent years, solid dispersion technology has been paid more and more attention by the majority of pharmaceutical workers. In addition to changing the solubility of drugs in common preparations, research in the field of slow-release preparations is increasing, and related technologies can be supplemented and improved. The carrier material of the solid dispersion has also been expanded, and the following aspects are summarized.