CN105616374A - Erlotinib hydrochloride tablet and preparation method thereof - Google Patents
Erlotinib hydrochloride tablet and preparation method thereof Download PDFInfo
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Abstract
The invention provides an erlotinib hydrochloride tablet. The erlotinib hydrochloride tablet is prepared from 109-164 parts by weight of erlotinib hydrochloride, 69-104 parts by weight of lactose, 120-180 parts by weight of microcrystalline cellulose, 5-50 parts by weight of sodium carboxymethyl starch, 0.1-1 part by weight of sodium dodecyl sulfate, 10-30 parts by weight of silica, 0.5-10 parts by weight of magnesium stearate and 0-25 parts by weight of a coating agent. The invention also provides a preparation method of the erlotinib hydrochloride tablet. The preparation method solves the problem that the fine raw materials can easily form airborne dust and has high adhesion and a slow dissolution rate. The preparation method utilizes a wet granulation process, improves raw material granularity and utilizes a wetting agent so that material airborne dust is greatly reduced and sticking possibility is reduced. Through wet granulation, the raw materials and accessory materials are uniformly dispersed and bonded with each other and layering possibility is reduced. Through prescription adjustment of silica addition, a raw material dissolution rate is improved. The erlotinib hydrochloride tablet provides a novel choice for clinical application.
Description
Technical field
The present invention relates to a kind of erlotinib Hydrochloride sheet.
Background technology
Erlotinib Hydrochloride sheet, English name: Tarceva (ErlotinibHydrochlorideTablets) trade name: Erlotinib; Double; two (2-the methoxyethoxy)-4-quinolinamine hydrochlorate of chemical name: N-(3-acetylene phenyl)-6,7-
This product is a kind of novel oral epidermal growth factor recipient tyrosine kinase inhibitor. Adenosine triphosphate (ATP) the binding pocket Idiotype in the tyrosine kinase domain district being positioned at HER1/EGFR molecule in Cytoplasm is combined. By suppressing the combination of adenosine triphosphate and HER1/EGFR, effectively suppress tyrosine kinase activity and downstream signal conduction, thus suppressing tumor cell proliferation, invasion and attack, transfer, reduce tumor cell adhesion ability, promote apoptosis of tumor cells, strengthen sensitivity to chemotherapy, thus extending tumor patient life cycle. Three lines treatments of the Locally Advanced failed for 2 or more than 2 chemotherapy regimens or the nonsmall-cell lung cancer (NSCLC) of transfer.
Erlotinib Hydrochloride is white extremely slightly yellow crystalline powder, the atomic water that is dissolved in, and preparation specification is relatively large, for 100mg, 150mg. Not disclosing concrete supplementary material formula and the technique of employing dry granulation, raw material is fine-powdered, and mobility is poor, it follows that raw material granularity relatively little Yi airborne dust, the dust removal requirement in workshop is high, and the harm of workman is big; The raw material adopting dry granulation mix with adjuvant after the technique of tabletting, there is higher risk of delamination, this belongs to the inherent defect of direct compression, it is possible to cause the problem that finished product content is uneven; In dry granulation process, raw material is relatively thin, viscosity is relatively strong, easily sticks on the gear of roll-in, need to clear up at any time; If clearing up not in time, material may result in the problem that product dissolution is slowed down after roll-in repeatedly.
How to improve the difficult problem that active component dissolution in the formulation is puzzlement those skilled in the art. Number of patent application: 201310731093.0, denomination of invention: tablet of a kind of hydrochloric Erlotinib and preparation method thereof, the invention discloses a kind of erlotinib Hydrochloride sheet, containing the silicon dioxide accounting for prescription gross weight 2��12%, dissolution can be promoted. The preparation method that the invention still further relates to described tablet, its technical process is simple, and to raw material granularity without particular/special requirement, product dissolution is good. By inventive embodiment it can be seen that this invention needs raw material and silicon dioxide to cross 100��200 mesh sieves. Because silicon dioxide density is less, therefore inevitably big volume production dirt in process of sieving; Two is adopt dry granulation process, therefore, however it remains problem that in dry granulation process, dust is bigger and the risk of material layering.
Application number: 201310051789.9, denomination of invention: erlotinib Hydrochloride sheet and preparation method thereof, the invention discloses a kind of erlotinib Hydrochloride sheet, containing HLB value surfactant between 10 to 20 as solubilizing agent, drug-eluting can be effectively facilitated, but this invention have selected grinds, with former, the surfactant that HLB value is inconsistent, cause that the risk of the vivo biodistribution inequivalence of preparation raises.
Application number: 201210429880.5, denomination of invention: a kind of erlotinib Hydrochloride Pharmaceutical composition and preparation method thereof, the present invention relates to a kind of erlotinib Hydrochloride Pharmaceutical composition and preparation method thereof. Crude drug, using erlotinib Hydrochloride as crude drug, is formed solid dispersion with disperse medium Polyethylene Glycol, then is equipped with filler, disintegrating agent and lubricant by the present invention, adopts pharmaceutically acceptable preparation technology granulation, tabletting or loads capsule. Pharmaceutical composition containing erlotinib Hydrochloride solid dispersion prepared by the present invention not only increases drug solubility, accelerates drug-eluting speed, thus improving the bioavailability of medicine, pharmaceutical quantities can be reduced to, reducing toxic and side effects, preparation technology is simple, is suitable for large-scale production. The method needs after preparing solid dispersion to adopt any special measures (such as x-ray powder diffraction, differential scanning calorimetry etc.) that product is characterized, and to prove to obtain target product, indirectly adds research and development and production cost; Two is the mechanism that this medicine fundamentally changes active component dissolution, even if this imitation medicine has reached to grind, with former, the level that quality is suitable in vitro, the risk of its vivo biodistribution inequivalence is still very high.
Summary of the invention
The technical scheme is that and provide a kind of erlotinib Hydrochloride sheet; The preparation method that another technical scheme of the present invention there is provided this erlotinib Hydrochloride sheet.
The invention provides a kind of erlotinib Hydrochloride sheet, it is the tablet being prepared from by the supplementary material of following weight percent:
Erlotinib Hydrochloride 109-164 part, lactose 69-104 part, microcrystalline Cellulose 120-180 part, carboxymethyl starch sodium 5-50 part, sodium lauryl sulphate 0.1-1 part, silica 1 0-30 part, magnesium stearate 0.5-10 part, coating materials 0-25 part.
It is further preferred that it is the tablet being prepared from by the supplementary material of following weight percent:
Erlotinib Hydrochloride 109-164 part, lactose 69-104 part, microcrystalline Cellulose 140-160 part, carboxymethyl starch sodium 8-15 part, sodium lauryl sulphate 0.5-1 part, silica 1 5-22 part, magnesium stearate 2-5 part, coating materials 9-18 part.
It is further preferred that it is the tablet being prepared from by the supplementary material of following weight percent:
Erlotinib Hydrochloride 109-164 part, lactose 69-104 part, microcrystalline Cellulose 145-147 part, carboxymethyl starch sodium 9-11 part, sodium lauryl sulphate 0.7-0.9 part, silica 1 7-19 part, magnesium stearate 4-5 part, coating materials 13-14 part.
It is further preferred that it is the tablet being prepared from by the supplementary material of following weight percent:
Erlotinib Hydrochloride 164 parts, lactose 104 parts, microcrystalline Cellulose 146.5 parts, carboxymethyl starch sodium 10 parts, sodium lauryl sulphate 0.8 part, silica 18 parts, magnesium stearate 4.5 parts, coating materials 13.5 parts;
Wherein, the particle size range of described erlotinib Hydrochloride is 60-100 order; Preferably, described particle size range is 60 orders.
Present invention also offers a kind of method preparing described erlotinib Hydrochloride sheet, it comprises the steps:
A, weigh the supplementary material of each weight proportion;
B, erlotinib Hydrochloride is crossed 60-100 mesh sieve; Adjuvant passes through 60 mesh sieves, progressively increases mode mix homogeneously by equivalent, then use lauryl sodium sulfate aqueous solution wet granulation, dry, adds magnesium stearate and mixes, tabletting, and coating obtains Tablets.
Wherein, the carboxymethyl starch sodium in adjuvant adds and dried addition respectively before granulation, and the weight proportion of the carboxymethyl starch sodium wherein added before granulation and the after drying carboxymethyl starch sodium of addition is: 2-8:1.
It is further preferred that the weight proportion of described the granulate front carboxymethyl starch sodium added and the dried carboxymethyl starch sodium added is: 2:1.
60 mesh sieves crossed by erlotinib Hydrochloride sheet Raw and adjuvant prepared by the present invention, compared with crossing 100 sieves, sieve easily and product dirt is less; Adopt wet granulation technology, it is possible to further reduce the product dirt problem in preparation process, and due to the combination between supplementary material so that material occurs the risk being layered relatively low in tableting processes. Additionally, use silicon dioxide in adjuvant of the present invention, this adjuvant does not affect the internal permeability of medicine, and wet method preparation process does not change the mechanism of preparation of Chinese medicine dissolution, and therefore, the risk being not result in vivo biodistribution inequivalence raises.
The preparation method of the pharmaceutical composition of the present invention, overcomes the problem that raw material too thin easily airborne dust, easily adhesion, dissolution are slower; The present invention adopts wet granulation technology, and raw material granularity increases, and is simultaneously introduced wetting agent, decreases the airborne dust of material to a great extent, be not easy to sticking. Material is by after wet granulation, dispersed and be combined with each other between raw material and adjuvant, is not easily layered, and by adjusting prescription, adds silicon dioxide, increases the dissolution rate of raw material, provide a kind of new selection for clinic.
Accompanying drawing explanation
The process chart of Fig. 1 present invention
The impact on stripping curve of Fig. 2 crude drug granularity
The impact on stripping curve of the consumption of Fig. 3 disintegrating agent
The impact on stripping curve of the consumption of Fig. 4 surfactant
The impact on stripping curve of the consumption of Fig. 5 silicon dioxide
The impact on stripping curve of the consumption of Fig. 6 microcrystalline Cellulose and silicon dioxide
Detailed description of the invention
The pharmaceutical composition of the present invention includes: API (erlotinib Hydrochloride), lactose monohydrate, microcrystalline Cellulose, silicon dioxide, carboxymethyl starch sodium, sodium lauryl sulphate, magnesium stearate and stomach dissolution type film coating agent. Amount ranges is as follows:
It is equal proportion convergent-divergent relation between note *: 100mg and 150mg specification.
The preparation technology of the pharmaceutical composition of the present invention is: 60 mesh sieves all crossed by raw material, adjuvant, progressively increase mode mix homogeneously by equivalent, then use lauryl sodium sulfate aqueous solution wet granulation, dry, add magnesium stearate and always mix, tabletting, coating. Amount ranges is as follows:
| Processing step | Final argument | State modulator recommended range | Preferable range scope |
| Grit number crossed by raw material | 60 orders | 60��100 orders | 60��80 orders |
| The concentration (w/w) of lauryl sodium sulfate aqueous solution | 0.5% | 0.4%��0.6% | 0.4%��0.5% |
| Dried moisture | 1��2% | 1��5% | 1��3% |
| Tablet hardness | 50��70N | 40��100N | 50��80N |
The process chart of the present invention is as shown in Figure 1:
The technological process of the present invention describes as follows:
1. material pretreatment: raw material, adjuvant are standby after sieving;
2. weigh: weigh that recipe quantity is former, adjuvant, pack, seal, mark;
3. prepare granulation solution: take recipe quantity sodium lauryl sulphate and be dissolved in a certain amount of purified water, make certain density solution, standby;
4. dispensing: take recipe quantity raw material successively with silicon dioxide, lactose, microcrystalline Cellulose, carboxymethyl starch sodium, mix by the equivalent mode of progressively increasing, be subsequently placed in trough type mixing machine mix homogeneously;
5. granulate: made granulation solvent in (3) is added soft material processed in (4), then through oscillating granulation; Wet grain drying is to moisture < 3%;
6. granulate, always mix: dry granule after granulate, add recipe quantity magnesium stearate, be placed in Mixers with Multi-direction Movement and always mix, pack, seal, weigh, mark;
7. intermediate detection: detection intermediates content, calculates theoretical tablet weight.
8. tabletting: adopt circular shallow concave punch, determine tablet weight according to intermediates content result, carry out tabletting, controls tabletting speed, tablet weight variation and tablet hardness in suitable scope. The plain sheet outward appearance simultaneously prepared, weight differential, content, dissolution etc. should meet regulation.
9. coating: take film coating agent, stirring adds in 80% ethanol water, is configured to certain density coating solution, continuous stirring (instant join); Pour into after element sheet is weighed in coating pan, control coating pan rotating speed, inlet temperature, leaving air temp; Carry out coating after adjusting spray gun spray pattern, after coating completes, reduce coating pan rotating speed, take the dish out of the pot when temperature is down to below 35 DEG C, weigh.
10. pack, Quan Jian, warehouse-in.
Following experimental example and embodiment are used for further illustrating but are not limited to the present invention.
Experimental example 1: the erlotinib Hydrochloride tablet containing varigrained raw material
Preparation method: by erlotinib Hydrochloride (crossing corresponding order number sieve net) and silicon dioxide, lactose, microcrystalline Cellulose, carboxymethyl starch sodium (inside adding), mix homogeneously, use lauryl sodium sulfate aqueous solution wet granulation, dry, add carboxymethyl starch sodium (additional), mix homogeneously, adds magnesium stearate, mixes tabletting.
Result is in Table-1 and Fig. 2.
Table-1. crude drug particle filter result
From the above results, the change of raw material granularity, the disintegration time of label is had no significant effect, but the granule character after disintegrate is had appreciable impact, with the reduction of raw material granularity, the granule after disintegrate is easily formed aggregate, is unfavorable for dissolution.
Stripping curve measurement result shows, the dissolution in 0.1mol/L hydrochloric acid, within the scope of 60��80 orders, is affected relatively big by crude drug granularity, when, after crude drug particle size reduction to 100 orders, reuniting occurs in the granule after disintegration of tablet, and dissolution is significantly slowed down; In pH6.8 phosphate buffer, after crude drug granularity is less than 100 orders, dissolution is significantly slowed down. To sum up, crude drug adopted 60 mesh sieves, it is preferable that particle size range is between 60��100 orders.
Embodiment 2: carboxymethyl starch sodium consumption screens
Preparation method: with embodiment 1. Result is in Table-2 and Fig. 3.
Table-2 carboxymethyl starch sodium consumption the selection result (n=3)
From the above results, on the basis of prescription A, increasing adding consumption in disintegrating agent carboxymethyl base Starch Sodium to 30mg/ sheet from 10mg/ sheet, tablet disintegration times increases to some extent, and disintegrate behavior also has significant change, presents the phenomenon first expanding disintegrate again; Within the scope of this, the stripping curve in 0.1mol/L hydrochloric acid is without notable change, and the stripping curve in pH6.8 phosphate buffer then occurs reducing (prescription F:30mg/ sheet). When increasing to 40mg/ sheet with disintegrating agent, the disintegration time of tablet does not have and slows down further, and the dissolution in two media all dramatically speeds up, but the dissolution in pH6.8 phosphate buffer do not bring up to yet with former triturate ( ) similar degree (f2=44), the dissolution in 0.1mol/L hydrochloric acid has been significantly faster than that former triturate simultaneously. It follows that only regulate carboxymethyl starch sodium add the purpose that consumption also can not reach to make the stripping curve in two media all consistent with former triturate. The consumption that adds tentatively drafting the carboxymethyl starch sodium in prescription is 10mg/ sheet, it is still necessary to investigate the other factors affecting laws to dissolution in prescription.
Embodiment 3: the consumption screening of surfactant
Preparation method: with embodiment 1. Result is in Table-3 and Fig. 4.
The consumption the selection result (n=3) of table-3 surfactant
From the above results, the stripping curve of tablet is had appreciable impact by the consumption of SDS. In 0.1mol/L hydrochloric acid, dissolution is under relatively low SDS consumption level (prescription A:0.18% and prescription C:0.37%), with the Similar Broken Line (f of former triturate2The factor respectively 62 and 59); When SDS consumption increases to 0.73% (prescription D), dissolution is decreased obviously, and grinds inconsistent (f with former2=36); And in pH6.8 phosphate buffer, dissolution dramatically speeds up with the increase of SDS consumption in prescription, prescription C and former triturate basic simlarity (f2=56), if continuing to increase SDS consumption, then it is likely to make the stripping curve in pH6.8 grind closer to former, but the dissolution in 0.1mol/L hydrochloric acid will be slowed down. To sum up, the impact of stripping curve in pH6.8 is noticeably greater than the impact of stripping curve in 0.1mol/L hydrochloric acid by the consumption of SDS, and affecting laws in two media is inconsistent, the consumption only regulating SDS can not make the stripping curve in two media all consistent with former triturate, it is still necessary to investigates the other factors affecting laws to dissolution in prescription.
Embodiment 4: the addition of silicon dioxide and consumption screening
Preparation method: with embodiment 1. Result is in Table-4 and Fig. 5.
The consumption the selection result (n=3) of table-4. silicon dioxide
From the above results, after adding the silicon dioxide of 3��4% in prescription, even if not additional disintegrating agent carboxymethyl base Starch Sodium, the disintegration rate of tablet also dramatically speeds up, dissolution in two media simultaneously is also accelerated, particularly in pH6.8 phosphate buffer, prescription I can arrive the dissolution degree (f of former triturate substantially2=59), to former grind similar; In 0.1mol/L hydrochloric acid, the early stage dissolution of prescription I has been significantly faster than that former grinding, remains to grind basic simlarity (f with former2=53). Therefore, primarily determine that silica content is account for label 4%.
Due to prescription I dissolution in 0.1mol/L hydrochloric acid and pH6.8 phosphate buffer, all present early stage (5��20min) to grind faster than former, later stage (30��60min) omits slow and the former feature ground, and its disintegrate (< 30 "); therefore; next step needs that prescription carries out some and finely tunes, and slightly slow down disintegration time, makes to be more nearly from the trend of film-making stripping curve and former triturate rapidly.
Embodiment 5: the optimization of microcrystalline Cellulose and silica content
Preparation method: with embodiment 4. Result is in Table-5 and Fig. 6.
The optimum results (n=3) of table-5 microcrystalline Cellulose and silica content
From the above results, after the consumption of microcrystalline Cellulose in prescription is reduced to 146.5mg/ sheet (accounting for label 33%, prescription J), the disintegrate of tablet is slightly slowed down, dissolution in 0.1mol/L hydrochloric acid and pH6.8 phosphate buffer all has slight decrease, f2The factor respectively 53 and 59, increases with the similarity of former triturate; Being increased after 5% by the consumption of silicon dioxide on this basis, tablet dissolution in 0.1mol/L hydrochloric acid is accelerated rapidly, (f no longer similar to former triturate2=30), it follows that the effect that silicon dioxide promotes disintegrate in this product is significantly stronger than microcrystalline Cellulose. To sum up, primarily determining that the consumption of microcrystalline Cellulose is 146.5mg/ sheet (about 33%), silica content is 18mg/ sheet (about 4%).
Claims (9)
1. an erlotinib Hydrochloride sheet, it is characterised in that: it is the tablet being prepared from by the supplementary material of following weight percent:
Erlotinib Hydrochloride 109-164 part, lactose 69-104 part, microcrystalline Cellulose 120-180 part, carboxymethyl starch sodium 5-50 part, sodium lauryl sulphate 0.1-1 part, silica 1 0-30 part, magnesium stearate 0.5-10 part, coating materials 0-25 part.
2. erlotinib Hydrochloride sheet according to claim 1, it is characterised in that: it is the tablet being prepared from by the supplementary material of following weight percent:
Erlotinib Hydrochloride 109-164 part, lactose 69-104 part, microcrystalline Cellulose 140-160 part, carboxymethyl starch sodium 8-15 part, sodium lauryl sulphate 0.5-1 part, silica 1 5-22 part, magnesium stearate 2-5 part, coating materials 9-18 part.
3. according to claim 2 it is characterized in that: it is the tablet being prepared from by the supplementary material of following weight percent:
Erlotinib Hydrochloride 109-164 part, lactose 69-104 part, microcrystalline Cellulose 145-147 part, carboxymethyl starch sodium 9-11 part, sodium lauryl sulphate 0.7-0.9 part, silica 1 7-19 part, magnesium stearate 4-5 part, coating materials 13-14 part.
4. erlotinib Hydrochloride sheet according to claim 3, it is characterised in that: it is the tablet being prepared from by the supplementary material of following weight percent:
Erlotinib Hydrochloride 164 parts, lactose 104 parts, microcrystalline Cellulose 146.5 parts, carboxymethyl starch sodium 10 parts, sodium lauryl sulphate 0.8 part, silica 18 parts, magnesium stearate 4.5 parts, coating materials 13.5 parts.
5. the erlotinib Hydrochloride sheet according to claim 1-4 any one, it is characterised in that: the particle size range of described erlotinib Hydrochloride is 60-100 order.
6. erlotinib Hydrochloride sheet according to claim 5, it is characterised in that: the particle size range of described erlotinib Hydrochloride is 60 orders.
7. the method preparing erlotinib Hydrochloride sheet described in claim 1-6 any one, it comprises the steps:
A, weigh the supplementary material of each weight proportion;
B, erlotinib Hydrochloride is crossed 60-100 mesh sieve; Adjuvant passes through 60 mesh sieves, progressively increases mode mix homogeneously by equivalent, then use lauryl sodium sulfate aqueous solution wet granulation, dry, adds magnesium stearate and mixes, tabletting, and coating obtains Tablets.
8. the preparation method of erlotinib Hydrochloride sheet according to claim 7, it is characterized in that: the carboxymethyl starch sodium in adjuvant adds and dried addition respectively before granulation, the weight proportion of the carboxymethyl starch sodium wherein added before granulation and the after drying carboxymethyl starch sodium of addition is: 2-8:1.
9. the preparation method of erlotinib Hydrochloride sheet according to claim 8, it is characterised in that: the weight proportion of described the granulate front carboxymethyl starch sodium added and the dried carboxymethyl starch sodium added is: 2:1.
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Application publication date: 20160601 |