CN111419811A - Tenofovir alafenamide fumarate composition - Google Patents
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Abstract
The invention describes a tenofovir alafenamide fumarate composition and a preparation method thereof. The composition comprises tenofovir alafenamide fumarate serving as an active ingredient and pharmaceutically acceptable auxiliary materials including a diluent, a lubricant and a flowing agent. Compared with the prior art, the tenofovir alafenamide fumarate composition prepared by the invention has the characteristics of simple preparation process and stable product, is taken by patients without water, is particularly suitable for patients with dysphagia or patients who cannot obtain liquid such as water, and more importantly, the pharmaceutical composition has good taste, and greatly improves the medication compliance of the patients.
Description
Technical Field
The invention belongs to the field of medicinal preparations, relates to a medicinal composition and a preparation method thereof, and particularly relates to a tenofovir alafenamide fumarate chewable tablet which is simple in preparation process, stable in product, convenient to take, capable of being taken without water, capable of effectively covering the bitter taste of a main medicament and more suitable for patients with dysphagia or patients who cannot obtain water and other liquids, and a preparation method thereof.
Background
The global prevalence of chronic Hepatitis B (HBV) is high, especially the drug resistance variability of hepatitis B virus and the embedding of hepatitis B virus DNA fragments into hepatocytes, so that the complete cure of chronic hepatitis B becomes a great challenge for human beings, and global scientists and various large pharmaceutical companies have been concerned about the development of drugs in this treatment field.
Nucleoside analogues are used for treating chronic hepatitis B, and the antiviral effect and the important position of the nucleoside analogues are gradually widely accepted. However, with the advance of clinical practice, people gradually recognize that the nucleoside compounds (such as lamivudine, adefovir, telbivudine and even entecavir which is marketed in later stage) used in the early stage in clinic have risks of inducing drug resistance of patients to different degrees, so that the sensitivity of viruses to other drugs is reduced, which brings difficulties for the subsequent antiviral treatment. At present, the clinical drug resistance of HBV to nucleoside (acid) analogues has become a great difficulty in treating chronic hepatitis B.
Tenofovir (PMPA) developed by Jilide and Tenofovir Disoproxil (TDF) subjected to structural modification subsequently bring about eosin for treating chronic hepatitis B, TDF is considered to be a nucleoside analogue with the strongest antiviral activity in the world since the TDF is continuously marketed in various countries of the world in 2008, and almost no drug resistance problem exists, so that the TDF is now a first-line treatment drug for chronic hepatitis B.
In order to solve the safety problem of drug administration, the deep research on Tenofovir by girard continues, and another Tenofovir structural analogue, Tenofovir Alafenamide Fumarate (TAF) (formula 1), which is a prodrug of Tenofovir, is developed, and hydrolyzed in vivo into Tenofovir, and then Tenofovir diphosphate is formed by phosphorylation of cellular enzymes, and Tenofovir diphosphate inhibits activities of HIV-1 reverse transcriptase and HBV reverse transcriptase by competing with 5-deoxyadenosine triphosphate, which is a natural substrate, and terminating DNA strands after integration with DNA.
Clinical results show that TAF has very high antiviral efficacy at a dose of only one tenth of TDF (25mg), and research data prove that TAF 25mg has non-adverse effects on clinical efficacy relative to TDF300mg, and can improve renal function and bone side effects and increase medication safety of patients. TAF tablets (trade name: Vemlidy, 25mg standard, tablet dosage form) were first approved in the United states in 2016 and then subsequently approved in Japan, European Union, China, and the like, respectively, worldwide for the treatment of adult and juvenile chronic hepatitis B.
The chemical structure of the tenofovir alafenamide fumarate used as a prodrug of tenofovir determines that the compound has the defect of extreme instability, and the phospholipid bond in the molecular structure is easy to hydrolyze to generate impurities such as PMPA, monophenyl PMPA, PMPA monoamide and the like, so that the important concern in the preparation process of the tenofovir alafenamide fumarate is how to prevent the main drug from degrading and improve the stability of the main drug.
The original research product TAF (Vemlidy) is a common tablet coated with a film, and a Norfovir alafenamide enteric-coated tablet is disclosed in the patent CN201811632863, although the degradation of the main drug in gastric acid is avoided, a patient still needs to take the norfovir alafenamide enteric-coated tablet with water and other liquids when taking the norfovir alafenamide enteric-coated tablet, so that the patient is inconvenient to take the norfovir alafenamide enteric-coated tablet under the environment that the water and other liquids cannot be obtained, and the swallowing of the tablet is a great challenge for the patient with difficulty in swallowing.
At present, research and development of tenofovir alafenamide fumarate chewable tablets are not available at home and abroad, and the invention can enrich clinical medication dosage forms of tenofovir alafenamide fumarate and more importantly can be conveniently used by patients with dysphagia or in water-deficient environments.
Because tenofovir alafenamide fumarate has a certain bitter taste, it is particularly important for chewable tablets how the bitter taste is masked. The existing solid oral preparation has a plurality of taste masking technologies, and the conventional method is to add flavoring agents such as sweetening agents, aromatic agents, taste potentiators, thickening agents, taste bud paralytic agents and the like into the prescription, and also add bitter blocking agents into the prescription. The preparation process includes coating, granulating, making microsphere or microcapsule, and mixing with cyclodextrin to form inclusion compound or ion exchange resin to form composite.
Most of the taste masking technologies have complicated preparation processes and are difficult to realize industrial mass production, or special auxiliary materials are used in the prescription, so that the production cost is greatly increased, or the introduction of water cannot be avoided in the preparation processes, so that the main medicine is degraded.
Most conventional techniques for masking the taste by adding sweeteners and aromatics to the formulation also require other functional adjuvants such as diluents, disintegrants, binders, etc. The development principle of the prescription of the pharmaceutical preparation is to simplify the prescription as much as possible and reduce the introduction of auxiliary materials as much as possible, so that the preparation process steps can be simplified, the production cost can be saved, the risk of incompatibility of raw materials and auxiliary materials can be reduced, and the medication safety can be improved.
Disclosure of Invention
The invention aims to solve the problems of the preparation of tenofovir alafenamide fumarate. The inventor finds that the problem of medication in the water-deficient environment of a patient can be solved by preparing tenofovir alafenamide fumarate into chewable tablets, and starch hydrolyzed oligosaccharide selected in a prescription for preparing the chewable tablets can be used as a diluent for direct powder tabletting or dry granulation tabletting, so that the main drug is prevented from being degraded due to the introduction of water, and the main drug is prevented from being hydrolyzed during preparation and long-term storage. In addition, the starch hydrolysis oligosaccharide is a purified carbohydrate obtained by enzymatic hydrolysis of starch, the sweetness of the starch hydrolysis oligosaccharide is enough to cover the bitter taste of the main drug, and the starch hydrolysis oligosaccharide is used as a diluent used in a large amount in the prescription and can be accepted by patients, so that the medication compliance of the patients is greatly improved, and the aim of simplifying the prescription composition is also fulfilled.
Compared with the prior art, the invention has the following advantages:
1. the invention takes the starch hydrolysis oligosaccharide with excellent fluidity and compressibility as the diluent, and the self sweetness of the diluent completely covers the defect of bitter taste of the main medicine, thereby increasing the medicine taking compliance of patients, and the application of the starch hydrolysis oligosaccharide simultaneously used as the diluent and the flavoring agent avoids adding a sweetening agent for taste covering, thereby simplifying the prescription composition, reducing the production cost and simultaneously increasing the medicine safety.
2. The invention adopts the production process of powder direct compression or dry granulation tabletting, avoids the introduction of water, prevents the main drug from hydrolysis in the long-term preparation process, and has the advantages of simple preparation process, easy industrialized mass production and stable product;
3. the medicine can be chewed and sucked by patients, and the patients do not need to take the medicine with liquid such as water, and the medicine is particularly suitable for patients with dysphagia or under the condition that the liquid such as water cannot be obtained.
4. At present, the tenofovir alafenamide fumarate only has film-coated tablets and enteric-coated tablets disclosed in patent CN201811632863, and the invention overcomes the defect of single oral dosage form and enriches the medication options of doctors and patients.
The invention relates to a tenofovir alafenamide fumarate preparation, which comprises the following components in part by weight:
(1) a pharmaceutically effective amount of tenofovir alafenamide fumarate; and
(2) at least one pharmaceutically acceptable excipient.
The invention relates to a palatable tenofovir alafenamide fumarate preparation; and
(1) a pharmaceutically effective amount of tenofovir alafenamide fumarate; and
(2) at least one pharmaceutically acceptable excipient, said formulation being palatable to the patient.
The invention relates to a tenofovir alafenamide fumarate preparation; and
(1) a pharmaceutically effective amount of tenofovir alafenamide fumarate; and
(2) at least one medicinal excipient, and the preparation is tablets, chewable tablets, buccal tablets, dispersible tablets, preferably chewable tablets.
The invention relates to a tenofovir alafenamide fumarate preparation, which comprises tenofovir alafenamide fumarate and a pharmaceutically acceptable excipient, wherein the tenofovir alafenamide fumarate (calculated by tenofovir alafenamide) is contained in each tablet in an amount of 5-25 wt%, the excipient comprises a diluent in an amount of 70-95% of the preparation, a flow agent in an amount of 0.5-5.0 wt% of the preparation and a lubricant in an amount of 0.5-5.0 wt% of the preparation.
The pharmaceutical formulation of tenofovir alafenamide fumarate of the present invention, wherein the amount of tenofovir alafenamide fumarate is 25mg calculated as tenofovir alafenamide.
The invention relates to a preparation method of a tenofovir alafenamide fumarate preparation, which comprises the following steps:
(1) mixing tenofovir alafenamide fumarate and a pharmaceutically acceptable excipient in a mixer;
(2) the mixture was compressed into tablets.
Wherein the process is carried out without wet granulation or drying.
The invention also relates to a preparation method of the tenofovir alafenamide fumarate preparation, which comprises the following steps:
(1) mixing tenofovir alafenamide fumarate and pharmaceutically acceptable excipients, compressing the resulting mixture into a mass or rolling into a strand, and grinding the prepared material into free-flowing granules;
(2) compressing the granules formed in step (1) into tablets.
Wherein the process is carried out without wet granulation or drying.
The invention relates to a preparation method of a preferable tenofovir alafenamide fumarate chewable tablet, which comprises the following steps:
(1) mixing tenofovir alafenamide fumarate and a pharmaceutically acceptable excipient in a mixer;
(2) the mixture was compressed into tablets.
Wherein the process is carried out without wet granulation or drying.
The tenofovir alafenamide fumarate, an active ingredient in the present invention, is very easily hydrolyzed, and thus it is desirable to prevent the hydrolysis from occurring during the formulation process, which poses a challenge to the formulation process, and for drugs that are very easily hydrolyzed, a process of granulating with water or other binders and drying is not desirable, which easily causes the hydrolysis of the active ingredient. Therefore, the process of powder mixing direct compression or the process of dry granulation and compression can be selected. Tenofovir alafenamide fumarate is poorly flowable, but at lower doses in pharmaceutical formulations, the flowability problem is ameliorated by the use of a higher proportion of a diluent which is well flowable, and a direct compression process using selective powder mixing is desirable. In addition, the tenofovir alafenamide fumarate and auxiliary materials can be subjected to dry granulation to improve the flowability, and then the subsequent tabletting process can be carried out.
The auxiliary materials selected in the preparation are particularly suitable for a powder direct compression process or a dry granulation process due to the excellent compressibility and flowability, wherein the diluent is starch hydrolysis oligosaccharide.
The diluent also has the function of being used as a sweetening agent, can completely cover the bitter taste of active ingredients, and greatly increases the medication compliance of patients.
The application of starch hydrolysis oligosaccharide as a diluent and a flavoring agent in chewable tablets is not seen in the prior art. The preferable chewable tablet preparation form of the invention can ensure that patients can take the medicine without taking the medicine with water, is convenient to take the medicine, is more suitable for patients with dysphagia or taking the medicine under the condition that liquid such as water and the like cannot be obtained, and increases the medication compliance of the patients.
The present invention is illustrated below by way of preferred examples, which are not intended to limit the disclosure of the present invention.
Detailed Description
Example 1
Preparation of Tenofovir alafenamide fumarate chewable tablet (25mg)
TABLE 1 formulation composition of Tenofovir alafenamide fumarate chewable tablets
The preparation method comprises the steps of crushing and sieving the raw material auxiliary materials, mixing the raw material auxiliary materials with the excipient, and tabletting after mixing, wherein specifically, the preparation steps of the 25mg chewable tablet are as follows:
(1) pulverizing tenofovir alafenamide fumarate, sieving with 60 mesh sieve, and sieving starch hydrolyzed oligosaccharide, silica gel micropowder and magnesium stearate with 40 mesh sieve respectively;
(2) mixing the tenofovir alafenamide fumarate and the starch hydrolysis oligosaccharide in the step (1) in a three-dimensional mixer for 20 minutes;
(3) adding the sieved micropowder silica gel and magnesium stearate, and continuously mixing for 6 minutes;
(4) and (4) directly tabletting the mixed powder in the step (3) by using a tabletting machine to obtain the tablet.
Example 2
Preparation of Tenofovir alafenamide fumarate chewable tablet (25mg)
TABLE 2 formulation composition of Tenofovir alafenamide fumarate chewable tablets
The preparation method comprises the steps of crushing and sieving the raw material auxiliary materials, mixing the raw material auxiliary materials with the excipient, and tabletting after mixing, wherein specifically, the preparation steps of the 25mg chewable tablet are as follows:
(1) pulverizing tenofovir alafenamide fumarate, sieving with 60 mesh sieve, and sieving starch hydrolyzed oligosaccharide, silica gel micropowder and magnesium stearate with 40 mesh sieve respectively;
(2) mixing the tenofovir alafenamide fumarate and the starch hydrolysis oligosaccharide in the step (1) in a three-dimensional mixer for 20 minutes;
(3) compressing the mixture into a strand-shaped material by adopting a dry granulator, and grinding the strand-shaped material into free-flowing particles;
(4) mixing the granules with the sieved micropowder silica gel and magnesium stearate for 6 minutes;
(5) and (4) tabletting the mixture obtained in the step (4) by using a tabletting machine to obtain the tablet.
Experimental example 1
Taste testing and raw research productsComparison of taste and flavor of original product
Taste tests were conducted by qualified physicians on the tenofovir alafenamide fumarate chewable tablets prepared in example 1 of the present invention. Taste questionnaires were distributed to 20 subjects aged 18-55 years. Each subject was asked to put a chewable tablet in the mouth, spit out and rinse after chewing for 15 seconds, and then each subject was allowed to hold 1 tablet of the original grinding TAF tablet (Vemlidy) for 5 seconds to simulate the actual medication process and then spit out the tablet. The subject is then asked to answer the questions in the questionnaire. The average score of the subjects for each question indicates the degree to which the chewable tablets prepared in example 1 and the original ground TAF tablets (Vemlidy) were taste-acceptable, respectively. Specifically, the question of how bitter the chewable tablet or the original ground TAF tablet was, resulted in average scores of 1.28 and 1.32, respectively, between "not bitter" and "slightly bitter", indicating that 20 subjects considered the taste of both the chewable tablet and the original ground TAF tablet (Vemlidy) acceptable, but better from a score point of view. The average scores obtained for the question "which is the most descriptive of your overall impression for the chewable tablet or original research TAF tablet (Vemlidy)" are 4.82 and 4.65 respectively (both between "neither liked nor disliked" and "slightly liked", and the chewable tablet is slightly better than the original research TAF tablet (Vemlidy)). The question of how you would score the taste of the chewable tablet or the original ground TAF tablet (Vemlidy) gave average scores of 4.75 and 4.54 (both between "neither liked nor disliked" and "slightly liked" and slightly better than the original ground TAF tablet (Vemlidy)), which all indicated that the taste of the chewable tablet was acceptable and slightly better than the original ground TAF tablet (Vemlidy).
TABLE 3 Scoring criteria for Key questions and average scores obtained
Claims (11)
1. A tenofovir alafenamide fumarate pharmaceutical formulation characterized by comprising tenofovir alafenamide fumarate and pharmaceutically acceptable excipients, wherein the amount of tenofovir alafenamide fumarate (calculated as tenofovir alafenamide) in each formulation unit is 5% to 25% by weight, the excipients comprise a diluent in an amount of 70% to 95% of the formulation, a flow agent in an amount of 0.5% to 5.0% by weight of the formulation and a lubricant in an amount of 0.5% to 5.0% by weight of the formulation, said formulation being prepared by a process comprising the steps of:
a. mixing tenofovir alafenamide fumarate and a pharmaceutically acceptable excipient in a mixer; or
b. Mixing tenofovir alafenamide fumarate and pharmaceutically acceptable excipients, compressing the resulting mixture into a mass or rolling into a strand, and grinding the prepared material into free-flowing granules;
c. compressing the mixture or granulate formed in step a or b into a tablet;
wherein the process is carried out without wet granulation or drying.
2. A process for the preparation of a tenofovir alafenamide fumarate pharmaceutical formulation comprising tenofovir alafenamide fumarate and a pharmaceutically acceptable excipient, wherein each formulation unit comprises tenofovir alafenamide fumarate (calculated as tenofovir alafenamide) in an amount of 5% to 25% by weight, the excipient comprising a diluent in an amount of 70% to 95% of the formulation, a flow agent in an amount of 0.5% to 5.0% by weight of the formulation and a lubricant in an amount of 0.5% to 5.0% by weight of the formulation, the process comprising the steps of:
a. mixing tenofovir alafenamide fumarate and a pharmaceutically acceptable excipient in a mixer;
b. compressing the mixture into tablets;
wherein the process is carried out without wet granulation or drying.
3. A process for the preparation of a tenofovir alafenamide fumarate pharmaceutical formulation comprising tenofovir alafenamide fumarate and a pharmaceutically acceptable excipient, wherein the amount of tenofovir alafenamide fumarate (calculated as tenofovir alafenamide) in each tablet is from 5% to 25% by weight, the excipient comprising a diluent in an amount from 70% to 95% of the formulation and a flow agent in an amount from 0.5% to 5.0% by weight of the formulation and a lubricant in an amount from 0.5% to 5.0% by weight of the formulation, the process comprising the steps of:
a. mixing tenofovir alafenamide fumarate and pharmaceutically acceptable excipients, compressing the resulting mixture into a mass or rolling into a strand, and grinding the prepared material into free-flowing granules;
b. compressing the granules formed in step a into tablets;
wherein the process is carried out without wet granulation or drying.
4. The pharmaceutical formulation of tenofovir alafenamide fumarate as claimed in claims 1, 2, 3 is a tablet, a chewable tablet, a buccal tablet, a dispersible tablet, preferably a chewable tablet.
5. The method for preparing a tenofovir alafenamide fumarate chewable tablet medicament of claim 2 or claim 3, wherein tenofovir alafenamide fumarate is pulverized and sieved with a 60-80 mesh sieve.
6. The formulation of claim 1 wherein the diluent is a starch hydrolyzing oligosaccharide.
7. The formulation of claim 1 wherein the flow agent is aerosil.
8. The formulation of claim 1, wherein the lubricant is magnesium stearate.
9. A tenofovir alafenamide fumarate chewable tablet of claim 1 comprising the following ingredients:
10. a tenofovir alafenamide fumarate chewable tablet of claim 1 comprising the following ingredients:
11. the tenofovir alafenamide fumarate chewable tablet of claim 1 and the preparation method of tenofovir alafenamide fumarate chewable tablet of claim 2, characterized by comprising the steps of:
a. grinding tenofovir alafenamide fumarate and then sieving the ground tenofovir alafenamide fumarate with a 60-80-mesh sieve;
b. b, uniformly mixing 14 parts of tenofovir alafenamide fumarate in the step a, 85 parts of starch hydrolyzed oligosaccharide, 0.5 part of superfine silica gel powder and 0.5 part of magnesium stearate in a three-dimensional mixer;
c. and c, directly tabletting the mixed powder in the step b by using a tabletting machine to obtain the tablet.
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