CN1473562A - Mouth cavity quick dissolving quick disintegrating freeze-dried tablet and its preparing method - Google Patents
Mouth cavity quick dissolving quick disintegrating freeze-dried tablet and its preparing method Download PDFInfo
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- CN1473562A CN1473562A CNA031302688A CN03130268A CN1473562A CN 1473562 A CN1473562 A CN 1473562A CN A031302688 A CNA031302688 A CN A031302688A CN 03130268 A CN03130268 A CN 03130268A CN 1473562 A CN1473562 A CN 1473562A
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- youngster
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Abstract
The oral cavity quick dissolving and quick disintegrating freeze dried tablet for children includes at least one medicinal active component and at least one medicinal stuffing, adhesive and other supplementary material. It is loose and porous tablet in network structure and prepared through common freeze drying process. The said medicinal active component may be different children's medicines, such as antibiotic, antipyretic, analgesic, cough stopping and phlegm eliminating medicine, cold medicine, etc. Bitter or excitant medicine may be coated and water insoluble medicine is prepared into fine powder of 50 micron below size for stable dispersion in liquid. The present invention has fast disintegration, no jamming in throat, simple preparation process and low cost.
Description
Technical field
The present invention relates to a kind of pharmaceutical dosage form, particularly relate to a kind of youngster with oral instant, rapidly disintegrating lyophilized and preparation method thereof.
Background technology
As everyone knows, allow preschooler (the particularly infant below the 3 years old) oral tablets be the bothersome thing of part, children's cries and screams during medicine feed, and father and mother worry.In order to solve the problem of above-mentioned child's oral administration, producer develops many oral Pharmaceutical dosage forms of being convenient to children, as granule, chewable tablet, dispersible tablet, effervescent tablet and various liquid preparation.Though the said medicine preparation has improved the compliance and the convenience of child's oral medication to a certain extent, still has weak point.Many infant are felt when the head of a family prepares administration, just begin uncooperatively, and the administration process is still very difficult; Add some medicinal preparation for oral administration and have the taste that is difficult to accept, the child is clear-cut, and refusal is taken medicine, and the head of a family has to adopt the method for perfusion by force, card larynx or cough and choke phenomenon very easily occur.In addition, for the sick child of dysphagia or under the situation of no drinking water, take the still very inconvenience of above-mentioned medicinal preparation for oral administration.
At the end of the seventies in last century, Britain Weyth company at first is applied in the technology (promptly so-called " zidys " technology) of injection lyophilized preparation to make on the oral drug preparation, begins to develop oral freeze-dried medicinal tablet.To the eighties, She Le company begins to participate in the suitability for industrialized production of efficient, the low consumption of oral freeze-dried medicinal tablet.British patent GB-A-1548022 and GB-A-2111423 disclose rapid disintegrating oral solid pharmaceutical dosage formulation and preparation method in a kind of oral cavity, this dosage form is the network structure substrate that is loaded with the opening of medicine, the substrate of this opening is for being inert water solublity or meeting the dispersible carrier material of water to medicine, lyophilization removes and desolvates from the solution that contains medicine and carrier material or suspension, the preparation solid dosage forms.U.S. Pat 539540,5120549, US5558880, US4546684,5330763, US6063802 and Chinese patent CN1085081, CN1290525, CN1171741 also disclose rapid disintegrating oral solid pharmaceutical dosage formulation and preparation method in a kind of oral cavity respectively.
But, utilize in the oral cavity that the freeze drying process of above-mentioned patent disclosure prepares rapidly that disintegrating oral solid pharmaceutical dosage formulation, particularly youngster usually do not reach ideal effect with the oral instant of specification, rapidly disintegrating lyophilized tablet, its reason has following several:
(1) pastille and the solution of carrier mass or the solid content of being prepared before the lyophilizing in the suspension, contained solvable or insoluble total solid matters amount in ie in solution or the suspension directly has influence on the cancellated situation of hole of lyophilized solid dosage form and the mechanical strength of this dosage form.If it is too much to contain solid thing, not only be difficult in the depression model of the plastic film system that is assigned to, products therefrom hole network structure is few, does not reach ideal speed and collapses instant effect.If solid content is few, then product is too loose, and hole is excessive, though it is fast to collapse molten speed in the oral cavity, product is appearance poor not only, and mechanical strength is also little, and is easily broken, even is difficult to take out from model and takes.The content that above-mentioned existing patented technology is treated partition liquid is not mentioned admittedly or is indeterminate.In addition, though above-mentioned existing patented technology has been done the regulation of amount to some material in the carrier (as the main matter as filler---mannitol, gelatin etc.), but do not consider active medicinal matter itself, big medicine of dose particularly, itself also be this situation of cancellated framework material, bring difficulty for the ideal freeze-dried drug dosage form of preparation.
(2) oral instant, rapidly disintegrating lyophilized are because be mushy network structure form, its bad mechanical strength, crush resistance is poor, in order to solve this shortcoming, above-mentioned existing patented technology has mostly strengthened the consumption as the gelatin of one of carrier mass, the gelatine content that has accounts for more than 20%, have near 40%.But the gelatin consumption is inappropriate, and particularly consumption is too much, will produce two problems: the one, if the gelatin consumption in the component is many, liquid to be allocated is gel (rather than suspension or solution) under the room temperature, is difficult to be dispensed in the polynary depression model.The 2nd, gelatin (under 37 ℃ human body temperature) at normal temperatures is difficult to water-solublely, and indissoluble is separated under the situation that saliva is less in the oral cavity still more.The oral instant of preparing like this, rapidly disintegrating lyophilized are difficult to rapid disintegrate and disperse in the oral cavity, if be used for the child then be easy to generate the danger of " card larynx ".
Summary of the invention
Technical problem to be solved by this invention is, overcome in the above-mentioned existing oral cavity shortcoming of disintegrating oral lyophilizing sheet and preparation method rapidly, a kind of child of being suitable for is provided, and particularly the youngster of the infant taking below 3 years old is with oral instant, rapidly disintegrating lyophilized and preparation method thereof.
In order to solve the problems of the technologies described above, the technical solution used in the present invention is: youngster of the present invention comprises with oral instant, rapidly disintegrating lyophilized: filler, binding agent and other adjuvants that at least a medicament active composition and at least a pharmacy are suitable for; Adopt general freeze-drying method to be prepared into loose and the cancellated lyophilizing tablet of tool hole.
Described active medicinal matter is meant the medicine of the different drug effects that can be used for the child, comprises that antibiotic or other antimicrobial drugs, analgesic antalgica, eliminating phlegm and stopping cough medicine, Coritab and other are suitable for child's medication.When medicine does not have serious bitterness or serious penetrating odor, can directly use.For heavy bitter taste or penetrating odor weight person, can adopt the coating powder of taste masking, but water-insoluble drug needs fine powder, granule＜50 μ m is so that stable being dispersed in the liquid.
The lyophilizing sheet that the youngster of being suitable for produced according to the present invention uses except that containing medicinal active substance, must add the filler that pharmacy is suitable for.Filler is the carrier of medicine, and forms the framework material of porous network structure.Filler among the present invention be meant water solublity that pharmacy is suitable for or water-insoluble but meet water dispersible, to pharmaceutical inert and the good material of lyophilizing formability, preferred mannitol, lactose, glucose, sucrose, sorbitol, xylitol, water solublity dextrin, water solublity pregelatinized Starch, maltose, glycine etc., preferred especially mannitol, xylitol, glycine, lactose.Above-mentioned filler both can be used separately, also available its mixture.
According to the present invention, the consumption of filler has important effect for prepared youngster with oral instant, rapidly disintegrating lyophilized, has influence on the porosity and the network structure situation of lyophilizing sheet, is directly connected to that the lyophilizing sheet dissolves in the oral cavity or the situation of disintegrate.Filler loading is many, and then lyophilizing sheet hole is few, and network structure is poor, and the lyophilizing sheet is too tight, and dissolving or disintegrate are then slow in the oral cavity; If filler loading is few, then Zhi Bei lyophilizing sheet hole is many, and tablet is too loose, though in the oral cavity dissolving or disintegrate disperse fast, appearance poor, bad mechanical strength, broken especially easily.According to the present invention, the consumption of filler depends on following two factors:
1. design the content of lyophilizing sheet Chinese medicine active ingredient.No matter be water-soluble active composition or water-insoluble active ingredient, after lyophilizing, all form solids, constitute the part of porous crack network structure lyophilizing sheet.Therefore, after the gross weight of lyophilizing sheet was determined, medicament active composition measured big person, and filler loading reduces; Little as the medicament active composition amount, then should increase the amount of filler.
2. She Ji lyophilizing sheet size.After the medicament active composition specification was determined, the sheet of design was great, and for reaching the suitable network structure that made lyophilizing sheet has, the also corresponding increase of then used depression model volume distributes the solution or the molten long-pending corresponding increase of suspension that enter, and then filler loading increases; Otherwise, should reduce consumption.
Youngster produced according to the present invention uses the drug solution or the suspension of oral instant, rapidly disintegrating lyophilized preparation, solvent for use is water and low-carbon (LC) alcohols, but special preferred water and concentration are lower than 30% ethanol water, its total solid content (weight/volume) should be between 5-40%, preferred 7.5-35%, preferred especially 10-25%.
Youngster produced according to the present invention is with oral instant, rapidly disintegrating lyophilized, also must add binding agent, the main effect of binding agent is adhesion medicament active composition, filler and other adjuvant in the lyophilized preparation of making, and guarantees that the lyophilizing sheet has suitable mechanical strength, crush resistance.The binding agent that the present invention is suitable for has natural gelatin substance, as gelatin, pectin, acacin, tragacanth, guar gum, arabic gum, Resina persicae, xanthan gum etc.; Synthetic polymer class material is as polyvinylpyrrolidone, carbomer, sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, polyethylene glycol oxide, polyvinyl alcohol and alginate etc.Preferred gelatin, polyvinylpyrrolidone, carbomer.According to the present invention, can use a kind of binding agent, also can use two or more binder combination.
Select for use gelatin as binding agent, if consumption is too much, under chamber state, drug solution preparation, to be allocated or suspension easily are gel, are difficult to quantitative branch to the model that caves in.If gelatin surpasses 10% in the weight of made lyophilizing sheet, then this lyophilizing sheet is put into the oral cavity and is difficult to be used for the danger that child Ze Yi produces " card larynx " in dissolving in 10 seconds or disintegrate.According to the present invention, select for use gelatin as binding agent, its consumption is the 0.2-15% of lyophilizing sheet weight, preferred 0.5-10%.
According to the present invention, the preparation youngster except that pharmaceutically active substance, filler, binding agent, also should add other materials that pharmacy is suitable for oral instant, rapidly disintegrating lyophilized, comprises surfactant, suspending agent, correctives, sweeting agent, pigment, antiseptic etc.
Youngster prepared in accordance with the present invention is with oral instant, rapidly disintegrating lyophilized, is insoluble to the pharmaceutically active substance of dosing solvent and filler and other adjuvants that various pharmacy is suitable for and is powder, and its granularity should＜50 μ m.
Youngster of the present invention comprises with the preparation method of oral cavity lyophilizing sheet:
Step 1. obtain solution and suspension: take by weighing active constituents of medicine, filler, binding agent and other adjuvants according to recipe quantity and be dissolved in or be scattered in the selected solvent, be prepared into solution and stable suspension.
Step 2. is freezed: above-mentioned solution or suspension are assigned in the polynary depression model on request, put into fridge quick freezing molding under Celsius-20--30 ℃ temperature then.
Step 3. sublimation drying: the powder charge model after will freezing is in freeze drying equipment, under the fine vacuum cryogenic conditions (temperature is lower than-40 ℃ Celsius, pressure 0.1-1.0 millibar) moisture is removed in distillation and suitable drying is removed residual moisture, and required time was according to the general 3-8 of amount of liquid in the model hour.
Step 4. pressing mold packing: will cover one deck aluminium foil on the product model plate after the lyophilizing.
The invention has the beneficial effects as follows: it is fast that youngster is collapsed molten speed with oral rapidly disintegrating, instant lyophilized, can dissolve fast within 10 seconds in the oral cavity or disintegrate disperses, and can prevent child's " card larynx " phenomenon of taking medicine effectively; Preparation method is simple and practical, low cost of manufacture.
The specific embodiment
Below in conjunction with the specific embodiment the present invention is described in further detail:
Embodiment 1
Youngster is (500) with amoxicillin lyophilizing sheet, its prescription:
Amoxicillin 25g (calculating) with anhydride
Mannitol 32g
Gelatin 2g
Polyethylene glycol 6000 3g
Flavoring orange essence 0.5g
The sweet 2.5g of A Siba
Methyl hydroxybenzoate 0.21g
Ethyl hydroxybenzoate 0.11g
Pure water adds to 250ml
Youngster comprises with the preparation method of amoxicillin lyophilizing sheet:
Step 1. crushing screening: amoxicillin, flavoring orange essence, aspartame, methyl hydroxybenzoate, ethyl hydroxybenzoate ground respectively sieve, make the fine powder of the about 50 μ m of granularity.
Step 2. preparation suspension: take by weighing each component according to recipe quantity, in 85% pure water, add gelatin stirring and dissolving under about 60 ℃ of temperature then, add the mannitol stirring and dissolving again, with the solution cool to room temperature, the fine powder that adds amoxicillin and other components then, after stirring, add other 15% pure water, stir and make stable suspension to 250ml.
Step 3. lyophilization: above-mentioned suspension is assigned in the special PVC plastic film depression model, each depression model 0.5ml suspension, put into fridge quick freezing under-30 ℃ of temperature, lyophilization under the condition of 1.0 millibars of temperature-40 ℃, vacuum, lyophilization cycle is 2.5 hours.
Step 4. covers epiphragma: take out the mould plate that contains the lyophilizing sheet from freeze dryer, with sealing behind the hot-press method covering layer of aluminum plastic film, get product.
Embodiment 2
Youngster is (100) with eliminating phlegm and stopping cough lyophilizing sheet, its prescription:
Dextromethorphan hydrobromide 0.5g
Guaifenesin 10g
Mannitol 6.5g
Resina persicae 0.5g
Crosslinked rope sodium carboxymethylcellulose pyce 0.32g
Polyethylene glycol 6000 0.8g
Aspartame 0.8g
Flavoring pineapple essence 0.8g
Methyl hydroxybenzoate 0.085g
Propylparaben 0.045g
Pure water adds to 250ml
Youngster is basic identical with the preparation method of amoxicillin lyophilizing sheet with the preparation method and embodiment 1 youngster of eliminating phlegm and stopping cough lyophilizing sheet, repeats no more here.
Embodiment 3
Youngster is (100) with acetaminophen lyophilizing sheet, its prescription:
Coating acetaminophen powder 9.4g (pure acetaminophen 8.0g)
Mannitol 4.0g
Glycine 3.0g
Gelatin 0.4g
Saccharin sodium 1g
PVP
K30 0.2g
Fructus Citri Limoniae essence 0.3g
Methyl hydroxybenzoate 0.085g
Propylparaben 0.045g
Pure water adds to 80ml
Youngster is basic identical with the preparation method of amoxicillin lyophilizing sheet with the preparation method and embodiment 1 youngster of acetaminophen lyophilizing sheet, difference only is: before step 2. preparation suspension, with ethyl cellulose, alcoholic solution the acetaminophen powder is carried out the coating taste masking and handle the pure acetyl aminophenol 8.0g that contains of coating acetaminophen.
Claims (10)
1. a youngster comprises: filler, binding agent and other adjuvants that at least a medicament active composition and at least a pharmacy are suitable for oral instant, rapidly disintegrating lyophilized; Described medicament active composition is antibiotic or other antibacterials, antipyretic analgesic, eliminating phlegm and stopping cough medicine, Coritab and other active constituents of medicine; It is characterized in that: described binder dosage is the 0.2-15% of lyophilizing sheet weight, and preferred amounts is 0.5-10%; The pastille of preparation and the solution (drug solution) or the suspension of various adjuvants before the lyophilizing, its solid content (weight/volume) is 5-40%, preferred solid content 7.5-35%, preferred especially solid content 10-25%.
2. youngster according to claim 1 is with oral instant, rapidly disintegrating lyophilized, it is characterized in that: the filler that described pharmacy is suitable for is meant medicament active composition is filler inert, good forming ability in preparation lyophilized solid dosage form that preferred mannitol, sorbitol, xylitol, lactose, glucose, maltose, glycine soluble dextrins or solubility are given gelling starch.
3. youngster according to claim 1 is with oral instant, rapidly disintegrating lyophilized, it is characterized in that: the binding agent that described pharmacy is suitable for is meant the natural gum class that pharmacy is suitable for, as gelatin, xanthan gum, guar gum, Resina persicae, pectin, tragacanth, acacin, the organic polymer class suitable with pharmacy, as sodium carboxymethyl cellulose, polyethylene, ketopyrrolidine, carbomer, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, polyethylene glycol oxide, polyvinyl alcohol and alginic acid salt, preferred gelatin PVP, carbomer.
4. youngster according to claim 1 is with oral instant, rapidly disintegrating lyophilized, it is characterized in that: the adjuvant that described other pharmacy are suitable for is meant surfactant, suspending agent, pigment, antiseptic, correctives and the sweeting agent that pharmacy is suitable for, and its kind and consumption are not done particular provisions.
5. youngster according to claim 1 is with oral instant, rapidly disintegrating lyophilized, and it is characterized in that: the state that is insoluble to the composition of dosing solvent in described active constituents of medicine and the adjuvant is the fine powder of the about 50 μ m of granularity.
6. youngster according to claim 1 is with oral instant, rapidly disintegrating lyophilized, and it is characterized in that: youngster is (500) with amoxicillin lyophilizing sheet, its prescription:
Amoxicillin 25g (calculating) with anhydride
Mannitol 32g
Gelatin 2g
Polyethylene glycol 6000 3g
Flavoring orange essence 0.5g
The sweet 2.5g of A Siba
Methyl hydroxybenzoate 0.21g
Ethyl hydroxybenzoate 0.11g
Pure water adds to 250ml
7. youngster according to claim 1 is with oral instant, rapidly disintegrating lyophilized, and it is characterized in that: youngster is (100) with eliminating phlegm and stopping cough lyophilizing sheet, its prescription:
Dextromethorphan hydrobromide 0.5g
Guaifenesin 10g
Mannitol 6.5g
Resina persicae 0.5g
Crosslinked rope sodium carboxymethylcellulose pyce 0.32g
Polyethylene glycol 6000 0.8g
Aspartame 0.8g
Flavoring pineapple essence 0.8g
Methyl hydroxybenzoate 0.085g
Propylparaben 0.045g
Pure water adds to 250ml
8. youngster according to claim 1 is with oral instant, rapidly disintegrating lyophilized, and it is characterized in that: youngster is (100) with acetaminophen lyophilizing sheet, its prescription:
Coating acetaminophen powder 9.4g (pure acetaminophen 8.0g)
Mannitol 4.0g
Glycine 3.0g
Gelatin 0.4g
Saccharin sodium 1g
PVP
K30 0.2g
Fructus Citri Limoniae essence 0.3g
Methyl hydroxybenzoate 0.085g
Propylparaben 0.045g
Pure water adds to 80ml
9. youngster according to claim 1 comprises with oral instant, rapidly disintegrating lyophilized preparation method: step 1. obtain solution and suspension, step 2. are freezed, step 3. sublimation drying and step 4. pressing mold packing; It is characterized in that: described step 2 is: will be assigned on request in the polynary depression model according to the solution or the suspension of step 1 preparation, put into-20 ℃ Celsius of fridge inherence then--quick freezing molding under 30 ℃ of degree temperature; Described step 3 is: the powder charge model after will freezing is in freeze drying equipment, under the fine vacuum cryogenic conditions (temperature is lower than-40 ℃ Celsius, pressure 0.1-1.0 millibar) moisture is removed in distillation and suitable drying is removed residual moisture, and required time was according to the general 3-8 of amount of liquid in the model hour.
10. youngster according to claim 9 is with oral instant, rapidly disintegrating lyophilized preparation method, it is characterized in that: the solution or the suspension of preparation before the lyophilizing, solvent for use is water and low-carbon (LC) alcohol solution (＜30% concentration), its solid content is in 5-40% (weight/volume), preferred solid content is at 7.5-35%, and preferred especially solid content is at 10-25%.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031302688A CN1473562A (en) | 2003-06-27 | 2003-06-27 | Mouth cavity quick dissolving quick disintegrating freeze-dried tablet and its preparing method |
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| CNA031302688A CN1473562A (en) | 2003-06-27 | 2003-06-27 | Mouth cavity quick dissolving quick disintegrating freeze-dried tablet and its preparing method |
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