CN108926540A - A method of for manufacturing the soft chewable dosage forms of drug delivery - Google Patents
A method of for manufacturing the soft chewable dosage forms of drug delivery Download PDFInfo
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
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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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
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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
- 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
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines having two or more nitrogen atoms in the same ring, e.g. oxadiazines
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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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
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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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- Life Sciences & Earth Sciences (AREA)
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- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Chemical & Material Sciences (AREA)
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Abstract
The present invention relates to a kind of methods for manufacturing the soft chewable dosage forms of drug delivery, belong to pharmaceutical technology field.Suitable soft chewable drug preparation includes non-active ingredient, and preferred non-active ingredient composition includes liquid adhesive system and solid excipient.Such preferred prescription of prescription compages object not only can be used traditional extruder or moulding press and carry out shaped preparation, but also common tablet press machine progress tabletting can be used and prepare soft chewable drug preparation, to get rid of the limitation constraint to molding equipment.It manufactures workable soft chewable drug carrier and does not need steady concentration low with finished product moisture content using heat, and then that offer active constituent is provided during mixing, to produce the uniform soft chewable drug carrier of, quality good to dog/cat palatability, quality.
Description
Technical field
The present invention relates to a kind of methods of soft chewable dosage forms for manufacturing drug delivery, belong to pharmaceutical technology field.
Background technique
The palatability of drug can increase the patient acceptability of drug, and the cat especially for animal, and in animal is to medicine
The palatability of object is more fastidious；Animal relatively tends to the solid pharmaceutical preparation of the forms such as swallow tablet or capsule, but very much
Active material mouthfeel itself is extremely bad (such as bitter taste, astringent taste), this makes animal palatability when taking drugs very poor.
Flavoring agent, corrigent or phagostimulant are used to improve the palatability of pharmaceutical preparation.Such as animal origin in veterinary drug
Flavoring agent (such as powdered beef, chicken liver meal, powder of pork, bovine bone powder, hepar siccatum, milk, gelatin, egg) or plant origin (such as soybean
Albumen etc.) flavoring agent be used in chewable tablets.
Although having used flavoring agent, corrigent or phagostimulant in chewable tablets, this is not sufficient to absorb people --- especially
It is the use of animal, in general, the i.e. soft chewable formulation (soft chewables) of " the edible soft chaw " of meat sample block, because
It has similar to cold cuts soft degree and smell (having both color and taste) and widely received by animal, especially cat this
The kind animal especially sensitive to taste.The soft chewable formulation of external listing registration includes at present：Heartgard(ivermectin/
pyrantel)、Quellin(carprofen)、Nexgard(afoxolaner)、Nexgard Spectra(afoxolaner/
milbemycin oxime)、Interceptor Plus(milbemycin oxime and praziquantel)、
Sentinel Spectrum (lufenuron/praziquantel/milbemycin oxime) etc..
Chinese patent CN105963270A (application number 201610507054.6) discloses a kind of soft nozzle of benazepril hydrochloride
Piece and preparation method thereof is chewed, needs to carry out fluidized bed coating processing to benazepil bulk pharmaceutical chemicals in the patent, and do not describe correlation
Molding equipment, so preparation process in the patent and technology can not be realized in field of veterinary and be mass produced；And the patent
The ratio of middle coating material and bulk pharmaceutical chemicals is unable to reach the effect of taste masking well at all, and specific ratio is referred to Chinese patent
The technological parameter for benazepil Cotton seeds mentioned in CN1652754B (application number 03810571.3).
Chinese patent CN100488376C (application number 200480021551) discloses for animals group of agreeable to the taste ductile chewable
Object is closed, i.e., corresponding Interceptor Plus, it is pest repellant (inside and outside) that this patent, which is applicable in active constituent, and it is to extrusion
Equipment requirement is very high (at least cloth strangles the above equipment of BCTG-62/28D model), while requiring when extrusion in low temperature (being lower than 10 DEG C)
Under the conditions of carry out, this patented method undoubtedly increases production cost, and is unfavorable for carrying out large-scale production and popularization at home and makes
With.
Chinese patent CN101909605B (application number 200880124524.4) discloses manufacture for the soft of drug delivery
Method of chewable dosage forms and products thereof is equally mentioned in this patent and needs to carry out fluidized bed coating processing, this patent to bulk pharmaceutical chemicals
Method increases production cost, requires height to equipment performance, is not suitable for being mass produced and being promoted the use of at home.
Currently, being learnt according to research data both domestic and external and patent information, the production of soft chewable formulation is generally by mixed
It is extruded from after closing uniformly.All supplementary materials are mixed in mixing machine in advance, add extruder or molding after mixing
In machine, by the extruding of screw rod, suitable size is squeezed out.The heat of compression can be generated in the process, and then for low melting point
Compound is not suitable for such method, and will affect the uniformity, consistency and stability of preparation.Or it is suppressed after mixing material
At big pie, it is being cut into suitable size.Used equipment is not raw for drug to these methods in process of production
The industrial equipment of production, or the equipment for having used particular/special requirement such as need low temperature or need to carry out specially treated to bulk pharmaceutical chemicals
(such as fluidized bed coating) is unfavorable for realizing the industrialized production of drug.(patent No. US4327077) is earliest in foreign patent
Soft chewable formulation is prepared using conventional tablet presses though mentioning, because there are will appear sticking, puckery punching when conventional tablet machines tabletting
Phenomena such as, patent at that time does not solve these problems.
Therefore, the process of chewable formulation soft for industrialized production is implicitly present in demand, wherein realizing optimization
Preparation prescription technique realizes the mass production of drug by equipment such as tablet press machines common in medicinal chewing tablet.Preferably, should
Method is not in the case where applying additional heat or not needing cryogenic conditions to carrying out under mixture or the product of formation.Made in soft chewing
Flavoring agent, corrigent or phagostimulant can increase the attraction to animal.Furthermore, it is therefore highly desirable to the preparation process side of soft chewing
Method, without using complicated production equipment, this method both may be used in the method for ensuring uniform soft chewing weight, quality and medicament contg
Mass production is realized on common extruder or moulding press in conventional patents or document, and common tablet press machine can be used and carry out
Industrialized production gets rid of constraint of the technology to equipment.
Summary of the invention
The present invention provides unique soft chewable drug preparation formulation and its manufacturing method, the soft chewable drug system in this method
Agent is especially agreeable to the taste, especially fastidious animal cat for animal.
The manufacturing method of the present invention allows the production of soft chewable formulation, uses preferred preparation recipe and technique, Wo Menyi
Traditional extruder or moulding press had can be used not only to be formed in outer discovery, but also can be used common in drug production
Tablet press machine realizes industrialized production, facilitates the mass production application for realizing pharmaceutical preparation, gets rid of the limitation to particular device and beam
It ties up.
Preferably, it is formed because using tablet press machine, does not need to generate or apply molding of the additional heat to complete preparation, it can
To protect the activity of active pharmaceutical ingredient well, low-temperature operation is not needed yet, reduces the requirement to equipment and environment.
Simultaneously, it was also found that in production process and can control the content of moisture in finished product, while reducing microorganism growth
Chance increases the stability of preparation.
One, the material for soft chewable formulation of the invention
In general, soft chewable formulation includes active pharmaceutical ingredient and non-active ingredient, the ordinary skill of this research field
Personnel are very familiar for these non-active ingredients.
In order to solve the problems, such as finally to use the mouldability of tabletting machine, the combined screening and wet granular of liquid adhesive
The control of moisture is even more important, so as to be not in sticking, puckery the phenomenon that rushing when soft chewable formulation tabletting, compressibility is good, solves
The mouldability problem of subsequent industrialized production.It has been surprisingly found that the prescription compages and preparation process of all choosings can be fine
Ground solves this problem, and making prepared wet granular not only can be used extruder or moulding press but also tablet press machine can be used.It is selected
Liquid adhesive combines：Water, polyethylene glycol, maltose, hydroxypropyl methylcellulose, glycerol, pungent certain herbaceous plants with big flowers acid glyceride, soybean oil,
Lecithin.It is preferred that water, glycerol and soybean oil are the combination of liquid, preferably polyethylene glycol is solid binder, the component of adhesive
Content is in 30-60%, preferably 45-55%.Solid binder and solid excipient are mixed together uniformly.
Solid excipient combination used includes starch, lactose, sucrose, microcrystalline cellulose, carboxymethyl starch in the present invention
It receives, croscarmellose sodium, calcium carboxymethylcellulose, crospovidone, beef flavor, fish meat flavor, iron oxide, core
One of flavine, famille rose etc. or a variety of compositions, solid excipient constituent content is in 40-70%, preferably 45-55%.
Any active medicinal matter that can be used for being administered orally can be provided as soft chewable formulation of the invention.The mankind and/
Or the those of ordinary skill of animal doctor's pharmaceutical field for these active medicinal matters is characterized in being completely familiar with, and includes but unlimited
In epizoa agent in antibody, antimicrobial, anti-full worm agent, analgesic agent, antiviral drugs, antiacid, anticonvulsive drug,
Hormone, vaccine, sedative, antihistamine, expectorant, minerals, micro-element etc..
The amount of every kind of ingredient can be different in finished product, this depends on physicochemical property, the indication, target of active constituent
The factors such as animal or people, dosage.Those of ordinary skill in the art will be adjusted according to the present invention in soft chewable formulation
The amount of given activity ingredient.In general, the range of active principle：It is preferred that 1.0%-50.0%, particularly preferred 1.0-
35.0%, preferred 1.0-20.0% are most preferably no more than 15.0%.For example, reference our company has authorized compound
Active material is anxious caused by dog peri-operation period and clinical operation etc. for treating to dog in patent (ZL201110160496.5)
Property, chronic ache and inflammation, aforementioned mixture can be added to by tieing up his former times cloth (Vitacoxib, referring to embodiment 1)
4.24%.
Benazepil is the drug of the diseases such as a kind for the treatment of hypertension (people), heart failure (dog) and albuminuria (cat), but
Benazepil drug itself is very bitter, and flavour problems cause it very poor using palatability in pet medicine, so Chinese patent
It is announced in CN1652754B (application number 03810571.3) a kind of using coating of pellets technology solution dog/cat palatability problems
Method, but it is very high to production equipment requirement.In this patent it has been surprisingly found that even if not being coated place to bulk pharmaceutical chemicals
Reason, dog/cat palatability is still fine, and (is specifically shown in embodiment 2 without influence to soft chewing quality.) so this patent can be with
Dog/cat palatability problems are solved without bulk pharmaceutical chemicals are coated with the process of processing, reduce the cost of mass production and to setting
Standby requirement.
Anthelmintic and antibiotic are suitable in occupation of the big dominant contribution in market two, the method for this patent in pet medicine by expelling parasite
Medicine and antibiotic exploitation are at suitable soft chewing, because pliability, smell or/and fragrance that soft chewing is made into meat piece make dog/cat
For which kind of essence and insensitive, this palatability for relatively substantially increasing pet especially cat with chewable tablets used, specifically
See embodiment 3.
Soft chewable formulation of the invention can be packed individually, for being administered and stable storage.Suitable packaging material includes
HDPE bottles of aluminum-plastic packaged or double aluminium packagings etc..
Two, the method for the soft chewable formulation of the manufacture present invention
Liquid adhesive combined system and solid excipient are first respectively configured in the present invention, then active constituent and solid are assigned
Shape agent is uniformly mixed, and liquid adhesive is added in solid excipient, wet granular is made, then is not needed during this mixing
Additional application heat, carries out, this is very suitable to for thermally sensitive drug under room temperature.By wet granular
Dry (preferably 3-6 hours) wet granular is to moisture between 3-8% under the conditions of low temperature (preferably more than 40 degree) is nonventilated
(preferably between 4-6%), crosses nylon mesh or steel sieve granulation, sieve mesh number use extruder less than 80 mesh (preferably 16-24 mesh)
Or the soft chewable formulation of moulding press or tablet press machine (suitable formed punch and mold) compacting suitable stiff, it is packed and stored.
Mixing apparatus includes but is not limited to wet granulator, flat mixer etc. common in pharmaceutical preparation production, this
Invent preferred mixing machine be band stir blade mixing machine, as patent (CN200480021551.0,
CN200880124524.4 the mixing machine mentioned in) be adapted to the present invention stir and evenly mix it is needed for.
Particularly preferably using the granulator of wet granulation in pharmaceutical preparation as mixing apparatus in the present invention, to reach more
Good mixture homogeneity, and do not have to it is additional apply heat, and can guarantee drug under gmp conditions manufacture environment.
More especially and be found surprisingly that be the preferred molding equipment being used in the present invention either extruder or
Moulding press can also be tablet press machine common in pharmaceutical production.The preparation process of preparation is especially important to equipment selection, preferably needs
It soft to soft chewing to be just that control moisture content is dried between 3-8% in wet granular, preferably 4-6% makes after moisture is qualified
Tabletting is then carried out less than 80 mesh (preferably 16-24 mesh) with nylon mesh or steel sieve granulation, sieve mesh number, selection is closed as needed
The soft chewing for the shape that suitable plunger chip die preparation needs.And it is preferred that the hardness for controlling soft chewable formulation is no more than 20N.
Detailed description of the invention
Fig. 1 is that the soft chewing of prescription 1 with his former times cloth chewable tablets is tieed up compares dissolution curve in main medium.
Specific embodiment
The present invention is adequately described, and the specific implementation of invention is illustrated by the following examples.Embodiment is unlimited
It is formed on the present invention, is completely limited by appended claims.
Embodiment 1：Containing the active constituent-prescription 1- preparation for tieing up his former times cloth
Formula composition is following (4000 batches, specification 80mg)：
Preparation process：
Glycerol, soybean oil and the water for mixing recipe quantity at room temperature, about mix 15 minutes and are allowed to uniform；Wet process is used at room temperature
The solid excipient of granulator mixing recipe quantity, mixing are allowed to uniform in about 20 minutes；Liquid adhesive is added slowly to mix
It closes in uniform stemness auxiliary material and continues stirring and obtain wet granular in 10 minutes；Use drying box (acyclic wind, set temperature 25
Degree) slowly keep wet granular dry to moisture between 3-8%, preferably 4-6%；Use nylon mesh or steel sieve granulation, sieve mesh
Number is less than 80 mesh (preferably 16-24 mesh)；It is formed using extruder or moulding press, or select suitable formed punch pressure using tablet press machine
Piece needs to control tabletting parameter to prevent glutinous punching, and hardness is no more than 20N；It packs (bottled or aluminum-plastic packaged).
Dog/cat palatability testing, product stability test are carried out to the soft chewing article of embodiment 1 and tie up his former times cloth nozzle
The dissolution Comparability test of piece is chewed, it is as a result as follows：
(1) 1 dog of soft chewing prescription/cat palatability testing
Dog is carried out using the soft chewing sample of prescription 1 and cat palatability is tested, as the result is shown the soft chewing sample dog of prescription 1
It is preferable with cat palatability, it can be effectively solved the palatability problems of dog and cat.Testing program：Select respectively 50 dogs and
Cat holds soft chewing to dog and cat, and actively feeding is denoted as actively receiving in 1 minute；If not searching for food actively in 1 minute, by soft nozzle
It chews and is put into dog and cat oral cavity, taken in 1 minute and be denoted as receiving, above situation is determined as palatability qualification；If being spat in 1 minute
Out or refusal takes, and is denoted as refusal, is determined as that palatability is unqualified, as a result see the table below.The soft chewing of prescription 1 is in dog and cat
Palatability is preferable, and overall receptance is all larger than 80%.
(2) soft 1 stability test of chewing prescription
By the soft chewing of prescription 1 respectively with it is bottled and aluminum-plastic packaged and place acceleration environment lower 6 months (40 DEG C ± 2 DEG C,
RH75% ± 5%) the soft chewing of observation stability, as a result see the table below.The soft chewing of prescription 1 under acceleration conditions stablize by quality, with 0
Month indifference.
(3) Comparability test is dissolved out
When the soft chewing of prescription 1 being compared the dissolution curve in main medium with his former times cloth chewable tablets is tieed up, and analyzing acceleration 6 months
Dissolution curve, accelerate 6 months (bottled) dissolution curve results and 0 month indifference (f as the result is shown2=51.56), prescription 1 is soft
Chewing dissolution curve compared with tieing up his former times cloth chewable tablets has similitude (f2=53.17), as shown in Figure 1.
Embodiment 2：Active constituent containing benazepil-prescription 2- preparation
Formula composition is following (4000 batches, specification 5mg)：
Preparation process：With embodiment 1.
Prescription 2 is subjected to agreeable to the taste Journal of Sex Research and stability study, it is as a result as follows：
(1) 2 dogs of soft chewing prescription/cat palatability testing
Dog/cat palatability testing such as following table.The results show that palatability of the prescription 2 on dog and cat (is greater than very well
80%).
(2) soft 2 stability test of chewing prescription
The soft chewing of prescription 2 is packed with bottled and placed acceleration environment lower 6 months (40 DEG C ± 2 DEG C, RH75% ± 5%)
The stability for observing soft chewing, as a result see the table below.The soft chewing of prescription 2 under acceleration conditions stablized by quality, with 0 month indifference.Have
Pass substance is impurity C, is the Thermo-sensitive feature degradation impurity in benazepil, equally exists in chewable tablets, with soft chewable formulation
It is unrelated.
Embodiment 4：Active constituent containing anthelmintic or antibiotic-prescription 3-8- preparation
Formula composition is following (4000 batches)：
Remarks：Active constituent used in prescription 3-5 is the compound preparation of praziquantel and milbemycin oxime, activity used in prescription 6-8
Ingredient is the preparation of horse slope sand star, and the essence of prescription 3-8 successively is natural chicken meat taste, natural chicken gizzard taste, natural bacon taste, people
Work chicken flavor, artificial chicken gizzard taste, artificial bacon taste.Preparation process：With embodiment 1.
Palatability investigation is carried out to prescription 3-8, it is as a result as follows：
(1) soft chewing prescription 3-8 dog/cat palatability testing
Dog/cat palatability testing such as following table (50).The results show that tried essence type palatability in dog and cat is good
It is good, processing is coated to bulk pharmaceutical chemicals without increasing additional technique.
| Prescription | Flavor varieties | Dog total pass rate (%) | Cat total pass rate (%) |
| Prescription 3 | Natural chicken meat taste | 98 | 84 |
| Prescription 4 | Natural chicken gizzard taste | 98 | 82 |
| Prescription 5 | Natural bacon taste | 100 | 82 |
| Prescription 6 | Artificial chicken flavor | 96 | 78 |
| Prescription 7 | Artificial chicken gizzard taste | 96 | 80 |
| Prescription 8 | Artificial bacon taste | 98 | 78 |
Claims (4)
1. a kind of method for manufacturing edible soft chewable drug carrier, which is characterized in that the soft chewable drug carrier
It is made of active pharmaceutical ingredient and non-active ingredient, wherein non-active ingredient includes the group of liquid adhesive and solid excipient
It closes.
2. as described in claim 1, it is characterised in that the preparation method is as follows：First be sufficiently mixed respectively liquid adhesive and
Solid excipient, the Auxiliary Liquid Material of mixing is added in solid mixture to be sufficiently mixed uniformly obtains wet granular, by wet granular
Dry (preferably 3-6 hours) wet granular is to moisture between 3-8% under the conditions of low temperature (preferably more than 40 degree) is nonventilated
(preferably between 4-6%) crosses nylon mesh or steel sieve granulation, and for sieve mesh number less than 80 mesh (preferably 16-24 mesh), wet granular both can be with
Using extruder or moulding press shaped preparation, and the soft of tablet press machine (suitable formed punch and mold) compacting suitable stiff can be used
Chewable formulation, control hardness are no more than 20N, are packed and stored.
3. as described in claim 1 and 2, it is characterised in that the inert matter includes：
(a) adhesive optimum organization system includes water, polyethylene glycol, maltose, hydroxypropyl methylcellulose, glycerol, pungent certain herbaceous plants with big flowers acid glycerol
At least one of ester, soybean oil, lecithin or a variety of combinations, preferably water, glycerol and soybean oil are the adhesive group of liquid
It closes, preferably polyethylene glycol is solid binder, and the constituent content of adhesive is in 30-60%, preferably 45-55%.Solid binder
It is mixed together uniformly with solid excipient.
(b) solid excipient combination include starch, lactose, sucrose, microcrystalline cellulose, carboxymethyl starch receive, cross-linked carboxymethyl it is fine
It ties up in plain sodium, calcium carboxymethylcellulose, crospovidone, beef flavor, fish meat flavor, iron oxide, riboflavin, famille rose etc.
At least one or more of composition, solid excipient constituent content is in 40-70%, preferably 45-55%.
4. traditional extruder or moulding press had both can be used in the wet granular of the technique preparation as described in claim 1-3
Shaped preparation, and common tablet press machine progress tabletting can be used and prepare soft chewable drug preparation, control suitable size and hardness
The uniform soft chewable drug preparation of edible quality, quality is obtained, the industrialized production for realizing drug is facilitated.
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| CN201710376866.6A CN108926540A (en) | 2017-05-25 | 2017-05-25 | A method of for manufacturing the soft chewable dosage forms of drug delivery |
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| CN201710376866.6A CN108926540A (en) | 2017-05-25 | 2017-05-25 | A method of for manufacturing the soft chewable dosage forms of drug delivery |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114796140A (en) * | 2022-04-29 | 2022-07-29 | 丽珠集团新北江制药股份有限公司 | Good-palatability milbemycin oxime praziquantel soft chewable tablets for animals and preparation method thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1829448A (en) * | 2003-07-30 | 2006-09-06 | 诺瓦提斯公司 | Palatable ductile chewable veterinary composition |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114796140A (en) * | 2022-04-29 | 2022-07-29 | 丽珠集团新北江制药股份有限公司 | Good-palatability milbemycin oxime praziquantel soft chewable tablets for animals and preparation method thereof |
| CN114796140B (en) * | 2022-04-29 | 2024-04-02 | 丽珠集团新北江制药股份有限公司 | Milbenoxime praziquantel soft chewable tablet with good palatability for animals and preparation method thereof |
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