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Abstract

The most suitable and helpful measurement structure is a container. the ability to conceal awful preferences and scents. They might work on the dynamic fixings' bioavailability and promptly break down in the gastrointestinal system's gastric juices. The calcium-channel blocker nifedipine is much of the time used to treat fundamental hypertension and angina pectoris. Nifedipine has a somewhat short half-existence of two hours and is totally solvent in water. Subsequently, it is by and large recognized that the best type of Nifedipine for routine hypertension treatment is in container structure. The essential objective of the exploration was to make and evaluate a hard gelatin case measurement type of nifedipine, which is utilized to treat hypertension. To work on the dissolvability of the prescription, polymers like Transcutol and Stake 400 were utilized.

Keywords

Nifedipine, Transcutol, Liquisolid compact, Less water soluble drug .

Introduction

The improvement of the oral medication conveyance framework primarily relies upon drug solvency, in this manner its oral bioavailability.[1] More than 90 % of dynamic drug fixings a work in progress and 50 % of as of now marketeddosage structures have dissolvability issues. Nifedipine is one of the most intense cal-cium-channel blockers. It is broadly utilized in the treatment of vascular illnesses, for example, hypertension, angina pectoris and Raynaud's peculiarity. it is a profoundly non-polar com-pound, which ingested totally from the gastrointestinal plot. However, has an exceptionally low bioavailability essentially due to presystemic digestion. On account of the restricted aque-ous solvency, it shows unfortunate disintegration attributes and its oral assimilation is dis-arrangement rate limited.The new 'liquisolid'' method might be applied to figure out fluid meds (i.e., slick fluid medications and arrangements, sus-annuities or emulsions of water-insoluble strong medications conveyed in nonvolatile fluid vehicles) into powder. liquisolid smaller method is a promising and novel procedure to upgrade inadequately water-dissolvable medications' dissolvability and disintegration rate.[2] In this strategy, the fluid type of a medication in a non-unpredictable dissolvable is changed over into dry-looking, non-follower, and openly streaming powder by usingcarrier and covering materials.[2, 3] The essential system behind liquisolid definitions is expanded wettability and surface region accessible for drug discharge. Thus, utilizing the liquisolid strategy, we can accomplish better bioavailability of ineffectively dissolvable medications.

Need :

The rationale behind the research is used for poor solubility of nifidipine in water.

Objective of liquisolid system :

  • Improve the bioavailability of water insoluble drug which are given by oral route.
  • Absorption can be enhanced.
  • Improve release of drug.

Application of Liquisolid Technique :

  • Solubility And Dissolution improvement
  • Flowability
  • Bioavailability improvement.

Liquid loading factors (Lf)

It is defned as the weight ratio of the liquid formulation (W) and the carrier material (Q) in the system:           

Lf = W/Q    (1)

(W is the weight of the liquid medication (the drug + non-volatile liquid vehicle) and Q is the weight of  the carrier.)

Represents the ratio between the weights of the carrier (Q) and the coating (q) material present in the formulation:

Then optimum weight of the coating material (q) could also be obtained (Equation 2).  

R=Q/q                              (2)                                                                           

The liquid load factor that ensures acceptable fowability (Lf) can be determined by:

Lf=?+ ?. (1/R)                  (3)

By calculating Lf and W, we can calculate the amount of Q and q required for the liquisolid system.

Theoretical Aspects of liquisolid system :

To accomplish ideal stream conduct and compressibility of liquisolid frameworks, a numerical model created by Spireas et al. was utilized as the detailing configuration model for the liquisolid tables. Requirements for this incorporate a reasonable medication competitor, a proper non-unstable dissolvable, transporter materials, and covering materials. The fluid stacking factors (Lf) and the flowable fluid maintenance possible qualities (X-esteem) are utilized to compute the measures of excipients (transporter and covering materials) utilized in the readiness of liquidsolid pieces.

MATERIALS & METHODS :

Materials

Nifedipine was obtained from J B chemicals & pharmaceutical Ltd , Transcutol was obtained from Gattefossé India Pvt. Ltd , Crospovidone was obtained from Cipla Ltd,  Polyethylene glycol (PEG) , Glycerol , Glycerine , Span 80 , Microcrystalline cellulose (MCC), Silicon dioxide , Starch were obtained from Loba Chemie Pvt Ltd.

Methods

  1. Micromeretics study:

The drug and excipient powder mix was subjected to following micromeretics study parameters.

  1. Angle of repose
  2. Bulk density
  3. Tapped density
  4. Compressibility index

1. Angle of Repose:

The point of rest is the most extreme point that structures between the outer layer of the powder heap and the even surface. The point of rest values for most of drug powders fall somewhere in the range of 25 and 45°; lower values signify better stream qualities [4]. The fix channel strategy was used for deciding point of rest. In the decent pipe technique, diagram paper is laid on a level even surface and a channel is situated with its tip at a foreordained level, H. Till the highest point of the conelike heap simply arrives at the channel's tip, powder or granulation is delicately poured through the pipe. Then, the point of rest is determined utilizing the distance across of the tapered heap's base [5].It is determined using the given formula,

tan? = h / r (1)

where, h is height of pile, r is radius of pile

               


Table 1: Angle of repose [6]


       
            Screenshot 2024-05-29 171326.png
       

    
 

2. Bulk Density:

The volume of a known mass of powder that went through the screen is used for determining the bulk density [4]. It is calculated by using the given formula,

Bulk Density =  M /????????     (2)

Where, 

M= Mass of sample,

Vb= Volume of sample [5].

3. Tapped density:

It is obtained by tapping the measuring cylinder containing known mass of powder and then measuring the volume of powder [7]. It was performed using the Electrolab’s tapped density apparatus.

4. Compressibility index:

Carr’s Compressibility index and Hausner ratio gives the indication about the ease with which a powder material can flow using following equations,

Carr’s Compressibility index (CI)

         (tapped density ? bulk density)

CI =  Tapped density                                     × 100                                (3)

tapped density

Hausner’s ratio (HR):

                         

 

                        Tapped density

HR =                                                                        (4)

                             Bulk density


Table 2: Scale of flowability for CI and HR [5]


       
            Screenshot 2024-05-29 171406.png
       

    ???????
 

  1. Determination of solubility

Nifedipine's solubility was tested in a variety of solvents, including water, PEG 400, propylene glycol, and Tween 20.  Excess medication was added to the vehicles to create saturated solutions, which were then shaken continuously for 48 hours at 25 ± 0.5°C. Following this time, the solutions were diluted, filtered, and UV-spectrophotometer-analyzed at 238 nm.[8]


Table 3 : Determination of solubility


       
            Screenshot 2024-05-29 171500.png
       

    ???????
 

  1. Carrier and coating material ratio

Carrier material

For a liquid vehicle, the carrier material should have strong absorption qualities and be porous in nature.[9] A restricted amount of liquid should be held by both the coating and the carrier materials while maintaining flowability and compressibility. Example : microcrystalline cellulose (MCC).

Coating Material

Typically, coating materials are made of coarsely ground particles that cover wet particles by absorbing excess liquid and producing a free-flowing, dry powder.[10] Example : Silicon Dioxide


Table 4: Carrier and coating material ratio


       
            Screenshot 2024-05-29 171528.png
       

    


Formulation design of liquisolid capsule:


Table 5: Formulation design of liquisolid capsule of Nifedipine


       
            Screenshot 2024-05-29 171610.png
       

    

Preparation of Capsule of Nifedipine : [11]

    • Placing Capsules in the Manual Capsule Filler.
    • Put empty capsules in the loading tray and place it onto the machine.
    • Pull locking handle forward, push down the long lever to lift the caps  of the capsule bodies.
    • Put the tray with caps aside.
    • Push the locking handle back and capsule bodies will come to the filling surface.
    • Filling Powder in the Capsules.
    • Put powder tray to avoid spilling of the powder.
    • Pour the right quantity of powder and spread it. Bring down the tamper and lock  it.
    • Turn the handle given above to compress the powder.
    • Bring up the tamper. Pour & spread the extra powder.
    • Covering the Capsules.
    • Put the tray with caps to filler and bring down the locking plate.
    • Lock the plate and turn the front knob to the right.
    • Push the long lever down to push capsule bodies into caps.
    • Open the locking plate lock, lift the locking plate and turn the front knob to the left.
    • Pull down the long lever and lift the tray with filled capsules.
    • Turn the tray to get filled capsules out of the tray.

C) Evaluation of Capsules:

1. Drug–polymer compatibility studies :

Due to their close proximity during the manufacture of the capsule formulation, the medicine and polymer may interact and cause the drug to become unstable. Therefore, choosing the right polymers requires careful consideration of preformulation studies pertaining to the drug-polymer interaction. The compatibility of nifedipine with the chosen polymers was determined using FT-IR spectroscopy[12].

3. Capsule evaluation :

  1. To measure the diameter and thickness of capsule shell and body by using Vernier caliper.
  2. To measure the height and length of whole capsule.

4. Weight Variation Test :

Capsules meet the requirements of the following test with respect to variation in weight of contents. Weigh 20 intact capsules individually, and determine the average weight. [13]The requirements are met if each of the individual weights is within the limits of 90% and 110% of the average weight.

5.Disintegration test :

Disintegration test was performed using the Disintegration test apparatus. One capsule introduced into each tube and added a disc to each tube. The assembly was suspended in the water in a 1000 ml beaker . [14]The volume of water such that wire mesh at its highest point is at least 25 mm below the surface of the water ,and its lower point was at least 25 mm above the bottom of the beaker . The apparatus was operated and maintained the temperature at 37+_ 2 degree celcius.[15]

Procedure of Disintegration : [16]

  • Preparation of 0.1 N HCL . Measure Accurately 8.62 ml HCL add in 1000 ml distilled water.
  • Clean the apparatus carefully and take 900 ml 0.1 N HCL in a beaker then maintain the temperature upto 37+/-0.2 degree celcius then add  the capsule in basket of 10 mesh sieve, Start the motor.
  • Switch and record the capsule release time.

6.Dissolution test :

Dissolution is the process in which a substance forms a solution. Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc. The dissolution of a drug is important for its bioavailability and therapeutic effectiveness.[17]

RESULT AND DISCUSSIONS:

  1. Micromeritics study :

The result of micromeretics properties of all the batches from Ls1 to Ls4 of capsule of nifedipine by liquisolid technique are shown in table 5. These batches were evaluated for parameters like bulk density, tapped density, Carr’s index, Hausner’s ratio and angle of repose. [18]


Table 6: Result of Micromeritics study on powder blend


       
            Screenshot 2024-05-29 171645.png
       

    

2. Drug–polymer compatibility studies :

Solubility studies were performed to select the solvent for liquisolid system. Table 3 explains the results of solubility studies.[18] Nifedipine showed maximum solubility in  Transcutol,  hence the  same was  selected as  non-volatile solvent.       

IR of Nifedipine   :      

Capsules were evaluated for Infrared Spectroscopy [19] , the Ls1 batch was showing the highest wavelength. The result for the test is given in image.



       
            Picture1.jpg
       

    



       
            Screenshot 2024-05-29 171716.png
       

    


Capsule evaluation :


Table 7 : Capsule evaluation

       
            Screenshot 2024-05-29 171716.png
       

    

Weight Variation Test :

Capsules were evaluated for weight variation test, the Ls1 batch was within the acceptable limits as per the IP, BP and USP[20]. The result for the test is given in table 8.


Table 8 : Weight Variation Test

       
            Screenshot 2024-05-29 171745.png
       

    

Formula : Average weight- Individual weight = NMT 7.5

251.65-253= 2

5.Disintegration test :

Capsules were evaluated for Disintegration test, the Ls1 batch was within the acceptable limits as per the IP, BP and USP[21]. The result for the test is 2.17 min .

6.Dissolution test :

The capsules belonging to all the 4 formulation were evaluated, all showed control release pattern for drug release for upto 40 min as given in table.[22] The test result showed that as the concentration of polymer was increases the amount of drug release was retarded. The formulation batch Ls1 showed the drug release about 94%.


Table 9: Concentration vs Absorbance


       
            Picture2.png
       

    

Table 10:Time and % drug release


       
            Screenshot 2024-05-29 171826.png
       

    ???????
       
            Picture3.png
       

    

CONCLUSION

In the present work, Nifedipine capsule prepared by liquisolid compact technique using polymer such as Tanscutol. The flow property of the powder  has shows satisfactory result for various physico-chemical evaluation of capsule .The in –vitro dissolution study of nifedipine capsule is tested in 0.1 N HCL. From the in-vitro dissolution study  it is observed that the increases in dissolution and bioavailability. As the solubility increases bioavalibility and rate of drug release increases. From the overall study concluded that Nifedipine drug capsule shows good release with good absorption .

REFERENCES :

  1. Vo CL, Park C, Lee BJ. Current trends and future perspectives of solid dispersions containing poorly water-soluble drugs. Eur J Pharm Biopharm. 2013;85:799–813. 10.1016/j.ejpb.2013.09.0072.
  2. Devi  S,  Kumar  S,  Verma  V,  Kaushik  D,  Verma  R,  Bhatia  M.  Enhancement  of  ketoprofen  dissolution  rate  by  the  liquisolid technique:  optimization  and  in  vitro  and  in  vivo  investigations.  Drug  Deliv  Transl  Res.  2022  Nov;12(11):2693-2707.  doi: 10.1007/s13346-022-01120-x.
  3. Lu M, Xing H, Jiang J, Chen X, Yang T, Wang D, Ding P. Liquisolid technique and its applications in pharmaceutics. Asian J Pharm. 2017;12:115-23.10.1016/j.ajps.2016.09.00713.
  4. Prasanna Kumar Desu, G.Vaishnavi, K. Divya, U.Lakshmi, An overview on Preformulation studies, Indo American Journal of Pharmaceutical Sciences, 2015, 2 (10), 1399-1407.
  5. Leon Lachman, Herbert A. Liberman, The Theory and practice of Industrial Pharmacy, CBS publishers, Fourth edition, 2013, 
  6. Shubhangi S. Pawar, Sanjay K. Bais, Sanket P. Shivsharan, Review on Preformulation Studies and Preparation of Preformulation Data Sheet, International Journal of Advanced Research in Science, Communication and Technology, 2023, 3(2), 318-328.
  7. Sandip Mohan Honmane, Yuvraj Dilip Dange, Riyaz Ali M. Osmani, Dhanraj Raghunath Jadge, General Considerations of Design and Development of Dosage Forms: Pre-formulation Review, Asian Journal of Pharmaceutics, 2017, 11(3), 479-488.
  8. Indian Pharmacopoeia, 4th Ed. Vol. I: Controller of Publications, Ministryof Health & Family Welfare, Govt. of India, Delhi; 1996: 511-13.11.
  9. Peddi MG. Novel drug delivery system: liquid-solid compact. J Mol Pharm Org Proc Res 2013;1:1-5.
  10. Swati M. Solubility enhancement of a drug by liquisolid technique. Int J Pharm Chem Bio Sci 2014;4:339-44.
  11. Sahir V, Ghuge N, Bakde BV. Liquisolid compact: a new technique for enhancement of drug dissolution. Int J Pharm Res Dev 2012;4:302-6.
  12. Baby JN, Manjila SB, Bijen EN, Constantine I, Pramod K, Valsalakumari J. Design and technology of liquisolid compacts. J Appl Pharm Sci 2013;3:111-9.
  13. Grover R, Spireas S, Wang T. Effect of powder substrate on the dissolution properties of methchrothiazide liquisolid compacts. Drug Dev Ind Pharm 1999;25:163-8.
  14. Papadimitriou SA, Bikiaris D, Avgoustakis K. Microwaveinduced enhancement of the dissolution rate of poorly watersoluble tibolone from poly (ethylene glycol) solid dispersions. J Appl Polymer Sci 2008;108:1249-58.
  15. Schiermeier S, Schmidt PC. Fast dispersible ibuprofen tablet. Eur J Pharm Sci 2002;15:295-305.
  16. Tiong N, Elkordy AA. Effects of liquisolid formulations on the dissolution of naproxen. Eur J Pharm Biopharm 2009;73:373-84.
  17. Nagabandi VK, Ramarao T, Jayaveera KN. Liquisolid Compacts. A novel approach to enhance bioavailability of poorly soluble drugs. Int J Pharm Bio Sci 2011;1:89-102.

Spireas S, Sadu S. Enhancement of prednisolone dissolution properties using liquisolid compacts. Int J Pharm 1998;166:177-88.

  1. Javadzadeh Y, Jafari-Navimipour B, Nokhodchi A, et al. a Liquisolid technique for dissolution rate enhancement of a high dose water-insoluble drug (carbamazepine). Int J Pharm 2007;341:26–34.
  2. Javadzadeh Y, Shariati H, Movahhed-Danesh E, et al., Effects of different grades of microcrystalline cellulose on flowability, compressibility and dissolution of liquisolid systems, Drug. Dev. Ind. Pharm. 2008; 1-9.
  3. Javadzadeh Y, Siahi MR, Asnaashri S, et al., An investigation of physicochemical properties of piroxicam liquisolid compacts, Pharm. Dev. Tech. 2007; 12: 337-34.
  4. https://www.researchgate.net/publication/309716266_Liquisolid_technique_and_its_applications_in_pharmaceutics.

Reference

  1. Vo CL, Park C, Lee BJ. Current trends and future perspectives of solid dispersions containing poorly water-soluble drugs. Eur J Pharm Biopharm. 2013;85:799–813. 10.1016/j.ejpb.2013.09.0072.
  2. Devi  S,  Kumar  S,  Verma  V,  Kaushik  D,  Verma  R,  Bhatia  M.  Enhancement  of  ketoprofen  dissolution  rate  by  the  liquisolid technique:  optimization  and  in  vitro  and  in  vivo  investigations.  Drug  Deliv  Transl  Res.  2022  Nov;12(11):2693-2707.  doi: 10.1007/s13346-022-01120-x.
  3. Lu M, Xing H, Jiang J, Chen X, Yang T, Wang D, Ding P. Liquisolid technique and its applications in pharmaceutics. Asian J Pharm. 2017;12:115-23.10.1016/j.ajps.2016.09.00713.
  4. Prasanna Kumar Desu, G.Vaishnavi, K. Divya, U.Lakshmi, An overview on Preformulation studies, Indo American Journal of Pharmaceutical Sciences, 2015, 2 (10), 1399-1407.
  5. Leon Lachman, Herbert A. Liberman, The Theory and practice of Industrial Pharmacy, CBS publishers, Fourth edition, 2013, 
  6. Shubhangi S. Pawar, Sanjay K. Bais, Sanket P. Shivsharan, Review on Preformulation Studies and Preparation of Preformulation Data Sheet, International Journal of Advanced Research in Science, Communication and Technology, 2023, 3(2), 318-328.
  7. Sandip Mohan Honmane, Yuvraj Dilip Dange, Riyaz Ali M. Osmani, Dhanraj Raghunath Jadge, General Considerations of Design and Development of Dosage Forms: Pre-formulation Review, Asian Journal of Pharmaceutics, 2017, 11(3), 479-488.
  8. Indian Pharmacopoeia, 4th Ed. Vol. I: Controller of Publications, Ministryof Health & Family Welfare, Govt. of India, Delhi; 1996: 511-13.11.
  9. Peddi MG. Novel drug delivery system: liquid-solid compact. J Mol Pharm Org Proc Res 2013;1:1-5.
  10. Swati M. Solubility enhancement of a drug by liquisolid technique. Int J Pharm Chem Bio Sci 2014;4:339-44.
  11. Sahir V, Ghuge N, Bakde BV. Liquisolid compact: a new technique for enhancement of drug dissolution. Int J Pharm Res Dev 2012;4:302-6.
  12. Baby JN, Manjila SB, Bijen EN, Constantine I, Pramod K, Valsalakumari J. Design and technology of liquisolid compacts. J Appl Pharm Sci 2013;3:111-9.
  13. Grover R, Spireas S, Wang T. Effect of powder substrate on the dissolution properties of methchrothiazide liquisolid compacts. Drug Dev Ind Pharm 1999;25:163-8.
  14. Papadimitriou SA, Bikiaris D, Avgoustakis K. Microwaveinduced enhancement of the dissolution rate of poorly watersoluble tibolone from poly (ethylene glycol) solid dispersions. J Appl Polymer Sci 2008;108:1249-58.
  15. Schiermeier S, Schmidt PC. Fast dispersible ibuprofen tablet. Eur J Pharm Sci 2002;15:295-305.
  16. Tiong N, Elkordy AA. Effects of liquisolid formulations on the dissolution of naproxen. Eur J Pharm Biopharm 2009;73:373-84.
  17. Nagabandi VK, Ramarao T, Jayaveera KN. Liquisolid Compacts. A novel approach to enhance bioavailability of poorly soluble drugs. Int J Pharm Bio Sci 2011;1:89-102.

Spireas S, Sadu S. Enhancement of prednisolone dissolution properties using liquisolid compacts. Int J Pharm 1998;166:177-88.

  1. Javadzadeh Y, Jafari-Navimipour B, Nokhodchi A, et al. a Liquisolid technique for dissolution rate enhancement of a high dose water-insoluble drug (carbamazepine). Int J Pharm 2007;341:26–34.
  2. Javadzadeh Y, Shariati H, Movahhed-Danesh E, et al., Effects of different grades of microcrystalline cellulose on flowability, compressibility and dissolution of liquisolid systems, Drug. Dev. Ind. Pharm. 2008; 1-9.
  3. Javadzadeh Y, Siahi MR, Asnaashri S, et al., An investigation of physicochemical properties of piroxicam liquisolid compacts, Pharm. Dev. Tech. 2007; 12: 337-34.
  4. https://www.researchgate.net/publication/309716266_Liquisolid_technique_and_its_applications_in_pharmaceutics.

Photo
Bhagyashri S. Jadhav
Corresponding author

Student of Pravara Rural College of Pharmacy

Photo
Dnyanda H. Kangude
Co-author

Student of Pravara Rural College of Pharmacy

Photo
Awantika N. Kale
Co-author

Student of Pravara Rural College of Pharmacy

Photo
S.D. Mankar
Co-author

Assistant Professor (Pharmaceutics Department) in Pravara Rural College of Pharmacy.

S.D. Mankar , Bhagyashri S. Jadhav , Dnyanda H. Kangude , Awantika N. Kale, Formulation And Evaluation Of Capsule Of Nifedipine By Liquisolid Compact, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 5, 1659-1669. https://doi.org/10.5281/zenodo.11385976

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