Fexofenadine Hydrochloride Dry Suspension and Its Preparation Method

Abstract

The present invention discloses a fexofenadine hydrochloride dry suspension and a preparation method thereof, which relates to the technical field of pharmaceutical preparations. The fexofenadine hydrochloride dry suspension of the present invention comprises the following components in percentage by weight: fexofenadine hydrochloride 1-6%, sodium docusate 0.01-0.06%, mannitol 1-6%, disodium hydrogen phosphate anhydrous 0.05-0.10%, citric acid 0.5-0.8%, polyvinylpyrrolidone K30 0.1-0.9%, sucrose 85-93% and silicon dioxide 0.1-0.5%. The present invention is prepared by a wet granulation method, and the obtained fexofenadine hydrochloride dry suspension has good uniformity, good taste and high stability.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical preparations, and particularly relates to a fexofenadine hydrochloride dry suspension and a preparation method thereof. Background Art

[0002] Fexofenadine hydrochloride has the chemical name of 2,2-dimethyl-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl] butyl] phenylacetic acid, and is a white or off-white powder. It is the active metabolite of terfenadine in the human body, and is a histamine H1 receptor antagonist without anticholinergic or α1-adrenergic receptor blocking effects. Fexofenadine hydrochloride has no adverse reaction of prolonging the cardiac QT interval like terfenadine, and has no rare cardiovascular toxicity that may be produced by the same kind of drug astemizole. It has good clinical therapeutic effects, belongs to the third-generation antihistamine drug without sedative effects, and is used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria.

[0003] Fexofenadine hydrochloride is readily soluble in methanol, soluble in absolute ethanol, slightly soluble in glacial acetic acid, and almost insoluble in water, chloroform, ether and acetone. At present, the dosage forms of fexofenadine hydrochloride approved for marketing in China are mainly tablets, capsules, suspensions and compound preparations with pseudoephedrine. However, tablets and capsules have the disadvantage of being difficult to swallow, and are not suitable for children, the elderly and patients with difficulty in swallowing. Coupled with the poor solubility of fexofenadine hydrochloride, in order to improve its bioavailability, many current studies focus on preparing it into a dry suspension. The dry suspension has the advantages of good drug absorption, uniform particle distribution after being made into a suspension, wide distribution area in the gastrointestinal tract, fast absorption and high bioavailability, and is suitable for children, the elderly and patients with difficulty in swallowing.

[0004] In the prior art, the patent application No. 201610477785.0 discloses a fexofenadine hydrochloride dry suspension and a preparation method thereof. The method is to dissolve fexofenadine hydrochloride and a binder in ethanol, and then jointly make granules with a filler and a solubilizer, and then mix them with an externally added suspending agent, glidant and flavoring agent to obtain the product, which solves the problems of poor solubility and slow dissolution. However, since the particle size of the flavoring agent particles is quite different from that of the prepared particles, and the prescription amount of fexofenadine hydrochloride is very small (the proportion is 1-3%), directly mixing the prepared particles with the externally added flavoring agent easily leads to poor uniformity, and the uniformity of packaging needs to be improved.

[0005] Patent application No. 202011628733.1 discloses a fexofenadine hydrochloride dry suspension and a preparation method thereof, wherein the method comprises wet granulation of an ethanol solution of a wetting agent and a flavoring agent with fexofenadine hydrochloride and a filler to obtain the fexofenadine hydrochloride dry suspension, which has good taste, good patient compliance, high stability, and improved drug solubility. Although sodium dioctyl sulfosuccinate is used as a wetting agent, the hydrophilicity of the drug and its dispersibility in water can be further improved.

[0006] Based on the above reasons, the purpose of the present application is to provide a fexofenadine hydrochloride dry suspension and a preparation method thereof to solve the problems of drug uniformity, wettability and dispersibility. Summary of the invention

[0007] In view of the above shortcomings, the present invention provides a fexofenadine hydrochloride dry suspension and a preparation method thereof. The prepared fexofenadine hydrochloride dry suspension has good uniformity, good dispersibility in water, and good suspension. It does not form cakes after sedimentation, can be quickly redispersed after shaking, has high stability, and has no gritty feeling when taken and has strong palatability. The specific technical scheme is as follows:

[0008] A fexofenadine hydrochloride dry suspension comprises the following components in percentage by weight:

[0009] Fexofenadine hydrochloride 1-6%, docusate sodium 0.01-0.06%, mannitol 1-6%, anhydrous disodium hydrogen phosphate 0.05-0.10%, citric acid 0.5-0.8%, povidone K300.1-0.9%, sucrose 85-93% and silicon dioxide 0.1-0.5%.

[0010] A fexofenadine hydrochloride dry suspension comprises the following components in percentage by weight: 4% of fexofenadine hydrochloride, 0.02% of docusate sodium, 4% of mannitol, 0.08% of anhydrous disodium hydrogen phosphate, 0.7% of citric acid, 0.8% of povidone K30, 90% of sucrose and 0.4% of silicon dioxide.

[0011] The present invention also provides a method for preparing a fexofenadine hydrochloride dry suspension, comprising the following steps:

[0012] (1) Weigh the above components according to the prescribed amount;

[0013] (2) firstly adding the fexofenadine hydrochloride into ethanol and dissolving it completely, then placing it in a wet granulator together with the povidone K30, anhydrous disodium hydrogen phosphate and citric acid, mixing and stirring, then adding purified water for granulation, passing through a 400-500 μm pore size sieve, and finally placing it in a fluidized bed for drying, and the obtained dry granules passing through a 100-200 μm pore size sieve to obtain first granules;

[0014] (3) Put the sodium docusate and mannitol into an ultrafine grinder and grind for 1 - 2 minutes, then add the first particles and grind together for 1 - 2 minutes to obtain the second particles.

[0015] (4) After crushing sucrose, mix and stir it together with silicon dioxide and the second particles in a wet granulator, then add purified water for granulation, screen through a sieve with a pore size of 300 - 450 μm, and finally dry in a fluidized bed. The obtained dry granules are screened through a sieve with a pore size of 100 - 200 μm to obtain the dry suspension of fexofenadine hydrochloride.

[0016] Preferably, the dosage of ethanol is 3 - 5 times the volume of fexofenadine hydrochloride.

[0017] Preferably, when mixing and stirring in the wet granulator, the stirring speed is 240 - 300 r / min and the stirring time is 5 - 8 minutes.

[0018] Preferably, when granulating in the wet granulator, the stirring speed is 240 - 300 r / min, the cutting speed is 1800 - 2500 r / min, and the granulation time is 5 - 10 minutes.

[0019] Preferably, the added amount of purified water is 5 - 10 times the weight of the mixed materials in the granulator.

[0020] Preferably, the inlet air temperature of the fluidized bed is controlled at 65 - 70 °C and the material temperature is controlled at 40 - 60 °C.

[0021] Preferably, the particle size of sucrose after crushing is 100 - 200 μm.

[0022] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0023] 1. The dry suspension of fexofenadine hydrochloride prepared by the present invention has good uniformity, fine dispersion in water, slow sedimentation, good suspension property, does not form cakes after sedimentation, can be rapidly redispersed after shaking, has high stability, and strong palatability.

[0024] 2. In the present invention, sodium docusate is used as a surfactant and mannitol is used as a wetting agent. After grinding sodium docusate and mannitol in an ultrafine grinder, the particles of sodium docusate and mannitol become smaller. When grinding together with the particles prepared from fexofenadine hydrochloride, a large number of small particles can adhere to the surface of the particles prepared from fexofenadine hydrochloride, improving the hydrophilicity of the medicament, making the prepared dry suspension have good dispersibility and strong wettability in water, and further making the medicament have less gritty feeling in the mouth and strong palatability.

[0025] 3. The combined use of sodium docusate and mannitol in the present invention can improve the suspension property and stability, and can meet the requirements that the dry suspension has fine dispersion, slow sedimentation, does not form cakes after sedimentation, and can be rapidly redispersed after shaking.

[0026] 4. The present invention uses sucrose after being crushed, which can improve the uniformity of the medicament, ensure that the drug content in each package is the same during dispensing, and at the same time has a better taste masking effect. Detailed implementation manners

[0027] The following is a detailed description of the specific implementation manners of the present invention, but it should be understood that the protection scope of the present invention is not limited by the specific implementation manners.

[0028] Example 1

[0029] Prescription:

[0030] Raw materials and proportions

[0031] Raw materials Weight percentage Function analysis Fexofenadine hydrochloride 6％ Main drug Sodium docusate 0.01％ Surfactant Mannitol 2％ Wetting agent Disodium hydrogen phosphate anhydrous 0.10％ Flocculant / buffer Citric acid 0.5％ pH regulator (taste masking agent) Polyvinylpyrrolidone K30 0.9％ Binder and suspending agent Sucrose 89.99％ Sweetening agent Silicon dioxide 0.5％ Glidant

[0032] Preparation method:

[0033] (1) Weigh each of the above components according to the prescription amount;

[0034] (2) First, add fexofenadine hydrochloride to an ethanol solution with a mass concentration of 95% and a volume 3 times that of fexofenadine hydrochloride, and dissolve it completely. Then, place it together with polyvinylpyrrolidone K30, disodium hydrogen phosphate anhydrous, and citric acid in a wet granulator, and mix and stir at a rotation speed of 240 r / min for 5 min to obtain a first mixture. Then, add purified water 5 times the weight of the first mixture, and granulate at a stirring speed of 240 r / min and a cutting speed of 1800 r / min for 5 min. Screen through a sieve with a pore size of 400 μm, and finally place it in a fluidized bed for drying, controlling the inlet air temperature at 60 °C and the material temperature at 45 °C. The obtained dry granules are screened through a sieve with a pore size of 100 μm to obtain the first granules;

[0035] (3) Put sodium docusate and mannitol into an ultrafine grinder and grind for 1 min, then add the first granules and grind together for 1 min to obtain the second granules;

[0036] (4) Crush sucrose to a particle size of 100 μm, and place it together with silicon dioxide and the second granules in a wet granulator, and mix and stir at a rotation speed of 240 r / min for 5 min to obtain a second mixture. Then, add purified water 5 times the weight of the second mixture, and granulate at a stirring speed of 240 r / min and a cutting speed of 1800 r / min for 5 min. Screen through a sieve with a pore size of 300 μm, and finally dry in a fluidized bed, controlling the inlet air temperature at 60 °C and the material temperature at 45 °C. The obtained dry granules are screened through a sieve with a pore size of 100 μm to obtain the fexofenadine hydrochloride dry suspension.

[0037] Example 2

[0038] Prescription:

[0039] Raw materials and proportions

[0040] Raw materials Weight percentage Function analysis Fexofenadine hydrochloride 1％ Main drug Sodium docusate 0.06％ Surfactant Mannitol 6％ Wetting agent Disodium hydrogen phosphate anhydrous 0.05％ Flocculant / buffer Citric acid 0.8％ pH regulator (taste masking agent) Polyvinylpyrrolidone K30 0.1％ Binder and suspending agent Sucrose 91.89％ Sweetening agent Silicon dioxide 0.1％ Glidant

[0041] Preparation method:

[0042] (1) Weigh each of the above components according to the prescription amount;

[0043] (2) First, dissolve fexofenadine hydrochloride completely in an ethanol solution with a mass concentration of 95% and a volume 5 times that of fexofenadine hydrochloride. Then, place it together with povidone K30, disodium hydrogen phosphate anhydrous, and citric acid in a wet granulator and mix and stir at a speed of 300 r / min for 8 min to obtain a first mixture. Then, add purified water 10 times the weight of the first mixture and granulate at a stirring speed of 300 r / min and a cutting speed of 2500 r / min for 10 min. Screen through a sieve with a pore size of 500 μm, and finally place it in a fluidized bed for drying. Control the inlet air temperature at 80 °C and the material temperature at 65 °C. Screen the obtained dry granules through a sieve with a pore size of 200 μm to obtain the first granules;

[0044] (3) Put sodium docusate and mannitol into an ultrafine grinder and grind for 2 min, then add the first granules and grind together for 2 min to obtain the second granules;

[0045] (4) Crush sucrose to a particle size of 200 μm, place it together with silicon dioxide and the second granules in a wet granulator, and mix and stir at a speed of 300 r / min for 8 min to obtain a second mixture. Then, add purified water 10 times the weight of the second mixture and granulate at a stirring speed of 300 r / min and a cutting speed of 2500 r / min for 10 min. Screen through a sieve with a pore size of 450 μm, and finally dry in a fluidized bed. Control the inlet air temperature at 80 °C and the material temperature at 65 °C. Screen the obtained dry granules through a sieve with a pore size of 200 μm to obtain the fexofenadine hydrochloride dry suspension.

[0046] Example 3

[0047] Prescription:

[0048] Raw materials and proportions

[0049] Raw materials Weight percentage Function analysis Fexofenadine hydrochloride 4％ Main drug Sodium docusate 0.02％ Surfactant Mannitol 4％ Wetting agent Disodium hydrogen phosphate anhydrous 0.08％ Flocculant / buffer Citric acid 0.7％ pH regulator (taste masking agent) Polyvinylpyrrolidone K30 0.8％ Binder and suspending agent Sucrose 90％ Sweetening agent Silicon dioxide 0.4％ Glidant

[0050] Preparation method:

[0051] (1) Weigh each of the above components according to the prescription amount;

[0052] (2) First, dissolve fexofenadine hydrochloride completely in an ethanol solution with a mass concentration of 95% that is 4 times the volume of fexofenadine hydrochloride. Then, place it together with povidone K30, disodium hydrogen phosphate anhydrous, and citric acid in a wet granulator and mix and stir at a rotation speed of 250 r / min for 7 min to obtain the first mixture. Next, add purified water that is 8 times the weight of the first mixture and granulate at a stirring speed of 250 r / min and a cutting speed of 2000 r / min for 8 min. Screen through a sieve with a pore size of 450 μm, and finally place it in a fluidized bed for drying. Control the inlet air temperature at 70 °C and the material temperature at 55 °C. Screen the obtained dry granules through a sieve with a pore size of 150 μm to obtain the first granules;

[0053] (3) Put sodium docusate and mannitol into an ultrafine grinder and grind for 2 min, then add the first granules and grind together for 1 min to obtain the second granules;

[0054] (4) Crush sucrose to a particle size of 150 μm, place it together with silicon dioxide and the second granules in a wet granulator, and mix and stir at a rotation speed of 250 r / min for 7 min to obtain the second mixture. Next, add purified water that is 8 times the weight of the second mixture and granulate at a stirring speed of 250 r / min and a cutting speed of 2000 r / min for 8 min. Screen through a sieve with a pore size of 400 μm, and finally dry in a fluidized bed. Control the inlet air temperature at 70 °C and the material temperature at 55 °C. Screen the obtained dry granules through a sieve with a pore size of 150 μm to obtain the fexofenadine hydrochloride dry suspension.

[0055] Dissolution test of the fexofenadine hydrochloride dry suspension of the present invention:

[0056] Use the fexofenadine hydrochloride dry suspension marketed in Japan as the reference preparation, and use the paddle method in the 2015 edition of the Chinese Pharmacopoeia to measure the dissolution data of the fexofenadine hydrochloride dry suspension prepared in each example in the pH 1.2 medium. The results are shown in Table 1:

[0057] Table 1 Dissolution test results

[0058] Item Dissolution rate at 15 min (%) Dissolution rate at 30 min (%) Dissolution rate at 60 min (%) Example 1 62 84 94 Example 2 64 86 95 Example 3 65 88 97 Reference preparation 66 87 95

[0059] Table 1 shows that the dissolution results of the fexofenadine hydrochloride dry suspension prepared in the present invention are basically similar to those of the existing commercially available products (reference preparation), and have a dissolution rate equivalent to that of the existing products.

[0060] Comparative Example 1

[0061] Prescription: The same as that in Example 3

[0062] Preparation method: Step (3) is omitted, that is, sodium docusate and mannitol are not ground. Instead, sodium docusate, mannitol, and the first particles are directly placed together with crushed sucrose and silicon dioxide in a wet granulator for granulation to obtain the product. Other steps are the same as those in Example 3.

[0063] Comparative Example 2

[0064] Prescription: The same as that in Example 3

[0065] Preparation method: In step (3), the grinding time of sodium docusate and mannitol in the ultrafine grinder is set to 4 minutes. Other steps are the same as those in Example 3.

[0066] Comparative Example 3

[0067] Prescription: The same as that in Example 3

[0068] Preparation method: In step (3), the co-grinding time with the first particles is set to 4 minutes. Other steps are the same as those in Example 3.

[0069] Comparative Example 4

[0070] Prescription: Mannitol is not included in the raw materials. The raw materials and their proportions are as follows:

[0071] Raw materials Weight percentage Function analysis Fexofenadine hydrochloride 4％ Main drug Sodium docusate 4.02％ Surfactant Disodium hydrogen phosphate anhydrous 0.08％ Flocculant / buffer Citric acid 0.7％ pH regulator (taste masking agent) Polyvinylpyrrolidone K30 0.8％ Binder and suspending agent Sucrose 90％ Sweetening agent Silicon dioxide 0.4％ Glidant

[0072] Preparation method: The same as that in Example 3.

[0073] Comparative Example 5

[0074] Prescription: Sodium docusate is not included in the raw materials. The raw materials and their proportions are as follows:

[0075] Raw materials Weight percentage Function analysis Fexofenadine hydrochloride 4％ Main drug Mannitol 4.02％ Wetting agent Disodium hydrogen phosphate anhydrous 0.08％ Flocculant / buffer Citric acid 0.7％ pH regulator (taste masking agent) Polyvinylpyrrolidone K30 0.8％ Binder and suspending agent Sucrose 90％ Sweetening agent Silicon dioxide 0.4％ Glidant

[0076] Preparation method: The same as that in Example 3.

[0077] Comparative Example 6

[0078] Prescription: The same as that in Example 3

[0079] Preparation method: In step (4), sucrose is not crushed. Other steps are the same as those in Example 3.

[0080] Stability test:

[0081] The sedimentation volume ratios of the fexofenadine hydrochloride dry suspensions prepared in each example and Comparative Examples 1 to 5 were tested separately. The testing method referred to the testing method for the sedimentation volume ratio of suspensions recorded in the Chinese Pharmacopoeia 2020 Edition. The larger the sedimentation volume ratio, the more stable the suspension. The suspensions dispersed in water and left for 3 days were placed in a graduated cylinder and rotated to redisperse them into a uniform system. The number of rotations required for redispersion was used to evaluate the redispersibility of each group. The fewer the number of rotations, the better the redispersibility. The measurement results are shown in Table 2:

[0082] Table 2 Sedimentation volume ratios and redispersibilities of each example and comparative example

[0083] Item Sedimentation volume ratio Dispersibility Example 1 0.98 Can be rapidly redispersed Example 2 0.96 Can be rapidly redispersed Example 3 0.99 Can be rapidly redispersed Control example 1 0.84 Redispersion speed is slower Control example 2 0.72 Difficult to redisperse Control example 3 0.82 Redispersion speed is slower Control example 4 0.87 Redispersion speed is slower Control example 5 0.82 Redispersion speed is slower

[0084] The data in Table 2 show that: from the data of the examples, it can be seen that the fexofenadine hydrochloride dry suspension prepared by the method of the present invention has good stability; from the comparison between Example 3 and Comparative Examples 1, 2 and 3, it can be seen that whether sodium docusate and mannitol are ground, the grinding time, and the co-grinding time of sodium docusate and mannitol with the main drug will all have a great impact on the stability of the finished product. The grinding time of sodium docusate and mannitol and the co-grinding time of sodium docusate and mannitol with the main drug set in the present invention can make the finished product have strong stability; from the comparison between Example 3 and Comparative Examples 5 and 6, it can be seen that the combined use of sodium docusate and mannitol in the present invention can improve the stability.

[0085] Taste evaluation:

[0086] Thirty adult volunteers with normal taste were selected to evaluate the taste of the fexofenadine hydrochloride dry suspensions prepared in each of the above examples and comparative examples. After randomly numbering the fexofenadine hydrochloride dry suspensions prepared in each of the above examples and comparative examples, the volunteers were asked to put them into their mouths respectively, feel the taste for 20 s, spit them out and gargle 5 times, and then measure the next one after there was no bitter taste in the mouth. After the volunteers fully felt the taste, the scores of bitterness and gritty feeling (each score range was 1-10) were recorded, and the sum of the three was calculated to obtain the total score. A total of two rounds were tried, and the average value was statistically analyzed. The higher the total score, the better the taste. The results are shown in Table 3:

[0087] Table 3 Taste evaluation results

[0088]

[0089]

[0090] Conclusion: The total scores of the examples are all higher than those of the comparative examples, indicating that the taste of the fexofenadine hydrochloride dry suspension prepared by the method of the present invention is relatively good; the data comparison between Example 3 and Comparative Examples 1 to 3 shows that the wettability of the medicament can be improved after sodium docusate and mannitol are ground, thereby reducing the gritty feeling. The data comparison between Example 3 and Comparative Examples 4 to 5 shows that the overall taste can be improved by using sodium docusate and mannitol in combination. The data comparison between Example 3 and Comparative Example 6 shows that the taste masking effect is better and the bitterness is less after sucrose is crushed.

[0091] In summary, the fexofenadine hydrochloride dry suspension prepared by the present invention has the characteristics of good uniformity, high stability, and strong palatability.

[0092] The foregoing description of the specific exemplary embodiments of the present invention is for purposes of illustration and exemplification. These descriptions are not intended to limit the invention to the precise forms disclosed, and obviously, many changes and variations are possible in light of the above teachings. The purpose of selecting and describing the exemplary embodiments is to explain the specific principles of the invention and its practical applications, so that those skilled in the art can implement and utilize the various different exemplary embodiments of the invention, as well as various different selections and changes. The scope of the invention is intended to be defined by the claims and their equivalents.

Claims

1. A fexofenadine hydrochloride dry suspension, characterized in that, It comprises components in the following weight percentages: Fexofenadine Hydrochloride 1 - 6%, Sodium Docusate 0.01 - 0.06%, Mannitol 1 - 6%, Disodium Hydrogen Phosphate Anhydrous 0.05 - 0.10%, Citric Acid 0.5 - 0.8%, Polyvinylpyrrolidone K30 0.1 - 0.9%, Sucrose 85 - 93% and Silicon Dioxide 0.1 - 0.5%; The preparation method of the dry suspension comprises the following steps: (1) Weigh each of the above components according to the prescription amount; (2) First, add the fexofenadine hydrochloride to ethanol and dissolve it completely, then place it in a wet granulator together with the polyvinylpyrrolidone K30, disodium hydrogen phosphate anhydrous and citric acid for mixing and stirring. Then add purified water for granulation, pass through a sieve with a pore size of 400 - 500 μm, and finally place it in a fluidized bed for drying. The obtained dry granules are passed through a sieve with a pore size of 100 - 200 μm to obtain the first granules; (3) Grind the sodium docusate and mannitol in a superfine grinder for 1 - 2 min, and then add the first granules and grind them together for 1 - 2 min to obtain the second granules; (4) After crushing the sucrose, place it in a wet granulator together with silicon dioxide and the second granules for mixing and stirring. Then add purified water for granulation, pass through a sieve with a pore size of 300 - 450 μm, and finally dry it in a fluidized bed. The obtained dry granules are passed through a sieve with a pore size of 100 - 200 μm to obtain the fexofenadine hydrochloride dry suspension.

2. The fexofenadine hydrochloride dry suspension according to claim 1, wherein It comprises components in the following weight percentages: Fexofenadine Hydrochloride 4%, Sodium Docusate 0.02%, Mannitol 4%, Disodium Hydrogen Phosphate Anhydrous 0.08%, Citric Acid 0.7%, Polyvinylpyrrolidone K30 0.8%, Sucrose 90% and Silicon Dioxide 0.4%.

3. The fexofenadine hydrochloride dry suspension according to claim 1, characterized in that, The amount of ethanol used is 3 - 5 times the volume of the fexofenadine hydrochloride.

4. The fexofenadine hydrochloride dry suspension according to claim 1, characterized in that When mixing and stirring in the wet granulator, the stirring speed is 240 - 300 r / min and the stirring time is 5 - 8 min.

5. A fexofenadine hydrochloride dry suspension according to claim 1, wherein When granulating in the wet granulator, the stirring speed is 240 - 300 r / min, the cutting speed is 1800 - 2500 r / min, and the granulation time is 5 - 10 min.

6. The fexofenadine hydrochloride dry suspension according to claim 1, characterized in that, The amount of purified water added is 5 - 10 times the weight of the mixed materials in the granulator.

7. A fexofenadine hydrochloride dry suspension according to claim 1, characterized in that, The inlet air temperature of the fluidized bed is controlled at 65 - 70 °C and the material temperature is controlled at 40 - 60 °C.

8. The fexofenadine hydrochloride dry suspension according to claim 1, characterized in that, After crushing, the particle size of the sucrose is 100 - 200 μm.

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