CN110559270B - Sitagliptin phosphate pharmaceutical composition and preparation method thereof - Google Patents
Sitagliptin phosphate pharmaceutical composition and preparation method thereof Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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Abstract
The invention belongs to the technical field of medicine preparation, and particularly relates to a sitagliptin phosphate pharmaceutical composition and a preparation method thereof. The sitagliptin phosphate pharmaceutical composition provided by the invention comprises the following components in percentage by weight: 30-40% of sitagliptin phosphate, 25-30% of microcrystalline cellulose, 20-30% of anhydrous dicalcium phosphate, 1-5% of disintegrating agent, 2-5% of lubricant and 2-5% of coating agent. The sitagliptin phosphate pharmaceutical composition prepared by the invention has high coating rate reaching 89%, so that the sitagliptin phosphate pharmaceutical composition has good stability under the conditions of high temperature, high humidity and illumination, and meanwhile, the tablet surface is smooth and attractive, and the compliance of patients can be improved.
Description
Technical Field
The invention belongs to the technical field of medicine preparation, and particularly relates to a sitagliptin phosphate pharmaceutical composition and a preparation method thereof.
Background
Type 2 diabetes is a metabolic disease caused by the body's inability to secrete sufficient insulin or to utilize the insulin poorly. With the increasing incidence of type 2 diabetes, sitagliptin phosphate has become increasingly popular as a novel antidiabetic agent.
Sitagliptin phosphate, white solid powder, soluble in water, slightly soluble in ethanol, acetone and acetonitrile. The tablet is a tablet preparation prepared by a certain preparation process of medicines and auxiliary materials, and has the characteristics of large yield, small volume, multiple types, small influence, high mechanization degree, low cost, accurate dosage, convenience in carrying and taking, good stability and the like. At present, known methods for preparing the sitagliptin phosphate pharmaceutical composition comprise a wet granulation method, a direct compression method and a dry granulation method, which are intermediate between physicochemical properties of the sitagliptin phosphate, so that the dry granulation method and the direct compression method are more suitable for preparing the sitagliptin phosphate pharmaceutical composition. However, the sitagliptin phosphate pharmaceutical composition obtained by the dry granulation and direct compression methods is unstable in high temperature, high humidity and light environment, so that the sitagliptin phosphate pharmaceutical composition needs to be stored under the conditions of sealing and avoiding light.
Chinese patent CN106822017A discloses a sitagliptin phosphate tablet and a preparation method thereof, and particularly discloses that the sitagliptin phosphate tablet comprises sitagliptin phosphate, a filler, a binder, a disintegrant and a lubricant, and the preparation method thereof, namely, a finished product of the sitagliptin phosphate pharmaceutical composition is obtained by dry granulation and coating. However, the preparation method does not describe the specific steps of coating in detail, and the specific steps of coating influence the performance of the prepared sitagliptin phosphate pharmaceutical composition.
Disclosure of Invention
The invention aims to provide a sitagliptin phosphate pharmaceutical composition and a preparation method thereof, the coating rate of the sitagliptin phosphate pharmaceutical composition prepared by the invention is high and reaches 89%, so that the sitagliptin phosphate pharmaceutical composition has good stability under the conditions of high temperature, high humidity and illumination, and meanwhile, the tablet surface is smooth and attractive, and the compliance of patients can be improved.
In order to achieve the purpose, the invention adopts the following technical scheme:
the sitagliptin phosphate pharmaceutical composition consists of the following components in percentage by weight:
30-40% of sitagliptin phosphate, 25-30% of microcrystalline cellulose, 20-30% of anhydrous dicalcium phosphate, 1-5% of disintegrating agent, 2-5% of lubricant and 2-5% of coating agent;
the coating agent comprises the following components in percentage by weight: 30-60% of liquid plasticizer and 5-50% of powder mixture;
the powder mixture consists of talc and a colorant.
Further, the liquid plasticizer is prepared from polyvinyl alcohol, triacetyl glyceride and polyethylene glycol according to a mass ratio of 1: (0.3-0.5): (0.6-1).
Further, the mass ratio of the talcum powder to the coloring agent is 1: 0.1 to 0.2.
Further, the colorant is titanium dioxide, iron oxide red or yellow iron oxide.
Further, the disintegrant is crosslinked carboxymethyl cellulose.
Further, the lubricant is magnesium stearate and/or sodium stearyl fumarate.
The invention also provides a preparation method of the sitagliptin phosphate pharmaceutical composition, which comprises the following steps:
A) taking sitagliptin phosphate, microcrystalline cellulose, anhydrous dicalcium phosphate, a disintegrating agent and a lubricant according to the formula ratio, and preparing a tablet core by adopting a powder direct tabletting method;
B) mixing the liquid plasticizer with the formula amount at the temperature of 30-45 ℃, and then filling the mixture into a liquid spray gun; mixing talcum powder and a coloring agent according to the formula ratio at 50-60 ℃, and then filling into a powder spray gun;
C) preheating the tablet core in the step A) in a rotary coating pan, controlling the temperature to be 30-45 ℃, and then respectively spraying a liquid spray gun and a powder spray gun on the coating pan to obtain a coated tablet;
D) and (3) keeping the coated tablet at the temperature of 30-45 ℃ for 60-72 hours, and curing to form a film to obtain the sitagliptin phosphate pharmaceutical composition.
According to the invention, the tablet core is coated by adopting a liquid plasticizer dry powder coating mode, so that the influence of water and an organic solvent in the coating process on sitagliptin phosphate is avoided, the temperature in the coating process is reduced to the glass transition temperature of a liquid tackifier, and the influence of high temperature on the sitagliptin phosphate is avoided. However, in the actual operation process, it is found that the stability of the coated sitagliptin phosphate pharmaceutical composition under the conditions of high temperature, high humidity and light is not in an ideal state, and the obtained sitagliptin phosphate pharmaceutical composition has rough and concave surfaces. Therefore, the inventors add triacetyl glyceride to improve the stability under high temperature, high humidity and light conditions, and the principle of triacetyl glyceride is that the capillary force between powder mixtures is enhanced, thereby improving the stability of the sitagliptin phosphate pharmaceutical composition under high temperature, high humidity and light conditions. Furthermore, it was found that the addition of triacetyl glyceride did not solve the problem of rough and concave surfaces, probably because the mixing temperature of the liquid thickener was close to the glass transition temperature, and when the mixing temperature of the powder mixture coated with the liquid thickener was low, the temperature of the liquid thickener on the tablet core was lowered, so that the powder mixture could not melt, and when the mixing temperature of the powder mixture was increased appropriately, the surface of the prepared sitagliptin phosphate pharmaceutical composition was smooth and beautiful.
Compared with the prior art, the invention has the following beneficial effects:
the sitagliptin phosphate pharmaceutical composition prepared by the invention has better stability under the conditions of high temperature, high humidity and illumination, has smooth and attractive surface, and greatly improves the compliance of patients.
Detailed Description
The present invention will be described in further detail with reference to the following examples. It should not be understood that the scope of the above-described subject matter of the present invention is limited to the following examples.
TABLE EXAMPLE 1 formulation of sitagliptin phosphate pharmaceutical composition
TABLE TWO EXAMPLES 1-3 coating agent formulations
Examples 1-3 the following preparation method was used, comprising the following steps:
A) taking sitagliptin phosphate, microcrystalline cellulose, anhydrous dicalcium phosphate, a disintegrating agent and a lubricant according to the formula ratio, and preparing a tablet core by adopting a powder direct tabletting method;
B) mixing the liquid plasticizer with the formula amount at 45 ℃, and then filling the mixture into a liquid spray gun; mixing talcum powder and a coloring agent according to the formula amount at 50 ℃, and then filling into a powder spray gun;
C) placing the tablet core in the step A) in a rotary coating pan for preheating, controlling the temperature to be 45 ℃, and then respectively spraying a liquid spray gun and a powder spray gun on the coating pan to obtain a coated tablet;
D) and (3) keeping the coated tablet at 45 ℃ for 72 hours, and curing to form a film to obtain the sitagliptin phosphate pharmaceutical composition.
Comparative example 1 sitagliptin phosphate pharmaceutical composition
Similar to example 1, except that: the coating agent was mixed at room temperature of 35 ℃ without addition of triacetyl glyceride, talc and a coloring agent, and the other parameters were the same as in example 1.
Comparative example 2 sitagliptin phosphate pharmaceutical composition
Similar to example 1, except that: the talc and the colorant were mixed at room temperature at 35 ℃ and the remaining parameters were the same as in example 1.
Comparative example 3 sitagliptin phosphate pharmaceutical composition
Similar to example 1, except that: talc powder and colorant were mixed at 40 ℃ and the remaining parameters were the same as in example 1.
Comparative example 4 sitagliptin phosphate pharmaceutical composition
Similar to example 1, except that: talc powder and colorant were mixed at 45 ℃ and the remaining parameters were the same as in example 1.
Comparative example 5 sitagliptin phosphate pharmaceutical composition
Similar to example 1, except that: talc powder and colorant were mixed at 55 ℃ and the remaining parameters were the same as in example 1.
Comparative example 6 sitagliptin phosphate pharmaceutical composition
Similar to example 1, except that: talc powder and colorant were mixed at 60 ℃ and the remaining parameters were the same as in example 1.
Comparative example 7 sitagliptin phosphate pharmaceutical composition
Similar to example 1, except that: talc powder and colorant were mixed at 65 ℃ and the remaining parameters were the same as in example 1.
Test I, quality detection
The sitagliptin phosphate pharmaceutical compositions prepared in examples 1 to 3 and comparative examples 1 to 7 were subjected to coating rate, hardness, tablet weight difference and appearance test.
Results of coating rate, hardness, tablet weight difference and appearance detection of the third layer
As can be seen from Table III, the sitagliptin phosphate pharmaceutical composition of example 1-3 has smooth and beautiful tablet surfaces, small tablet weight difference and high hardness and coating rate. Compared with example 1, the coating rate of comparative example 1 is low and the tablet surface is rough, and the coating rate of comparative example 2 is remarkably improved by adding triacetyl glyceride. It can be seen from comparative examples 2 to 7 that the mixing temperature of the powder mixture has an influence on the sheet-side appearance.
Test II, stability test
The test refers to the related requirements of the guidelines of the stability test of the raw material medicaments and the preparation under the guideline of the fourth part 9000 of the 'Chinese pharmacopoeia' 2015 edition.
The test method is as follows:
2.1 high temperature test: the sitagliptin phosphate pharmaceutical composition is placed in an open container, placed at the temperature of 60 ℃ for 10 days, sampled on the 5 th and 10 th days, and compared with the data on the 0 th day, the content of the sitagliptin phosphate is measured.
2.2 high humidity test: placing the sitagliptin phosphate pharmaceutical composition in a constant-temperature closed dryer for 10 days under the condition of relative humidity of 75% + -5% (NaCl saturated solution: relative humidity of 75% + -1%) at 25 ℃, sampling at 5 th and 10 th days, and comparing with the data of 0 th day, and measuring the content of the sitagliptin phosphate.
2.3 illumination test: the sitagliptin phosphate pharmaceutical composition is placed under the condition of illumination intensity (4500 +/-500) Lx for 10 days, samples are taken at 5 days and 10 days, and the content of the sitagliptin phosphate is measured by comparing with the data of the 0 days.
TABLE IV high-temperature high-humidity and illumination test results
As can be seen from Table IV, examples 1-3 have better stability in the high temperature test, the high humidity test and the light test. The comparative example 1 (without triacetyl glyceride added) had poor stability in the high temperature test, the high humidity test and the light test, compared to example 1, and the reason for this may be that the coating rate was low and the porosity of the formed coating film was large.
Experiment III, dissolution rate detection experiment
4.1 test methods: the test refers to the related requirements of the second method of the dissolution and release determination method under the guiding principle of the fourth 0931 part of the 'Chinese pharmacopoeia' 2015 edition. Taking 1000ml water as dissolution medium, rotating speed 50rpm, temperature 37 + -0.5 deg.C, and sampling 10ml at 5min, 10min, 15min and 30min respectively according to the method. The absorbance of the sample was measured at 275nm wavelength, and the amount of 5 tablets was measured for each example, and the dissolution rate of each example was calculated.
4.2 control drugs: pharmaceutical product prepared according to CN106822017A
Table five dissolution test results
| Dissolution rate | Example 1 | Example 2 | Example 3 | Control drug |
| 5min(％) | 41.9 | 41.2 | 41.1 | 47.3 |
| 10min(％) | 56.8 | 55.4 | 56.1 | 61.2 |
| 15min(％) | 69.2 | 68.7 | 68.9 | 72.9 |
| 30min(％) | 87.4 | 86.9 | 87.8 | 89.6 |
As can be seen from Table V, the dissolution rates of examples 1-3 at 5min and 10min were lower than those of the control drug product, which may be due to the higher coating rate of the sitagliptin phosphate pharmaceutical composition, resulting in lower early dissolution rate, while the dissolution rates of examples 1-3 were substantially identical to those of the control drug product with the increase of time.
The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.
Claims (5)
1. The sitagliptin phosphate pharmaceutical composition is characterized by comprising the following components in percentage by weight:
30-40% of sitagliptin phosphate, 25-30% of microcrystalline cellulose, 20-30% of anhydrous dicalcium phosphate, 1-5% of disintegrating agent, 2-5% of lubricant and 2-5% of coating agent;
the coating agent comprises the following components in percentage by weight: 30-60% of liquid plasticizer and 5-50% of powder mixture;
the powder mixture consists of talcum powder and a coloring agent;
the preparation method of the sitagliptin phosphate pharmaceutical composition comprises the following steps:
A) taking sitagliptin phosphate, microcrystalline cellulose, anhydrous dicalcium phosphate, a disintegrating agent and a lubricant according to the formula ratio, and preparing a tablet core by adopting a powder direct tabletting method;
B) mixing the liquid plasticizer with the formula amount at the temperature of 30-45 ℃, and then filling the mixture into a liquid spray gun; mixing talcum powder and a coloring agent according to the formula ratio at 50-60 ℃, and then filling into a powder spray gun;
C) preheating the tablet core in the step A) in a rotary coating pan, controlling the temperature to be 30-45 ℃, and then respectively spraying a liquid spray gun and a powder spray gun on the coating pan to obtain a coated tablet;
D) and (3) keeping the coated tablet at the temperature of 30-45 ℃ for 60-72 hours, and curing to form a film to obtain the sitagliptin phosphate pharmaceutical composition.
The liquid plasticizer is prepared from polyvinyl alcohol, triacetyl glyceride and polyethylene glycol according to a mass ratio of 1: (0.3-0.5): (0.6-1).
2. The sitagliptin phosphate pharmaceutical composition according to claim 1, wherein the mass ratio of the talcum powder to the coloring agent is 1: 0.1 to 0.2.
3. The sitagliptin phosphate pharmaceutical composition according to claim 2, characterized in that the colorant is titanium dioxide, red iron oxide or yellow iron oxide.
4. The sitagliptin phosphate pharmaceutical composition according to claim 1, characterized in that the disintegrant is cross-linked carboxymethyl cellulose.
5. Sitagliptin phosphate pharmaceutical composition according to claim 1, characterized in that the lubricant is magnesium stearate and/or sodium stearyl fumarate.
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| CN114159401A (en) * | 2021-11-18 | 2022-03-11 | 苏州天马医药集团天吉生物制药有限公司 | Sitagliptin phosphate tablet and preparation method thereof |
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| CN1162917A (en) * | 1994-10-07 | 1997-10-22 | 伯温德药品服务公司 | Enteric film coating compositions, method of coating therewith, and coated forms |
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