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Online First                                                                                                                      Indian J Pharm Drug Studies | 1  

Original Article 

Design and Development of Press Coated Pulsatile Release of Ketoprofen 

Tablets 

Srujana Gandrathi1, Padamatini Naveen kumar1, Chandrasekhara Rao Baru1, Sushma Desai2, M. 

Shiroja1, Raaga swetha1 

From, 1Assistant Professor, Department of Pharmaceutics, Chilkur Balaji college of Pharmacy, Moinabad Hyderabad, Telangana, 

India-500075, 2Research Scholar, Gitam University, Rudraram, Patancheru, Hyderabad, Telangana, India- 502329 

ABSTRACT 

Ketoprofen pulsatile tablets were developed and evaluated in this work utilizing synthetic  polymers grades Hydroxy propyl methyl 

cellulose (HPMC) E5, HPMCE15, and natural polymer xanthan gum. The angle of repose and compressibility index were determined 

to be within the acceptable range by pre-formulation investigations of core tablet granules, demonstrating excellent flow properties for 

compression. The core tablet underwent evaluation procedures that examined content homogeneity compliance, weight fluctuation 

within standard deviation (SD) ± 2%, hardness, and friability. Evaluations of the coated tablets showed that the weight fluctuation, 

hardness, and friability all fell within SD ± 2%. In vitro dissolving tests were conducted on formulations F1 through F9, and at the 

conclusion of the sixth hour, formulation 8 produced a pulsatile drug release. After the allotted period, the medication was released 

here at once. The stability study, which was conducted for two months for formulation 8 in accordance with International council of 

Harmonisation (ICH) requirements, was determined. 

Key words: ketoprofen; Press-coated pulsatile release tablet; Xanthan gum 

echnologies are evolving daily in the pharmaceutical 

industry, leading to the most effective dose form. In 

that regard, the most widely utilized and effective 

method of delivery has been oral for more design freedom for 

dose forms. Convenience and simplicity of administration [1-

5]. Their pharmaceutics excellence and therapeutic advantages 

over quick release pharmaceutical medicines have been 

acknowledged more and more in regulatory approval for 

commercialization [6-11]. Modified-release oral dosage forms 

have given fresh life to medications that had lost commercial 

potential because of gastrointestinal problems, toxic effects 

associated with dose, and the need for frequent administration 

[12-16]. When it comes to treating conditions like peptic ulcer, 

asthma, cardiovascular disease, arthritis, diabetes, and 

hypercholesterolemia, the above regulated and sustained 

release medication delivery method has limitations because 

these conditions rely on biological rhythms [17,18]. Pulsatile 

release is the main rationale for its use when continuous drug 

release, also known as zero-order release, is desired. In this 

current project, it is hypothesized that pulsatile drug delivery 

with various polymers ketoprofen drug effectiveness can be 

improved [19-24].  

Access this article online 

 

Received –  04th December 2025 

Initial Review –  08th December 2025 

Accepted – 10th December 2025 

Quick Response Code 

MATERIALS 

Ketoprofen was purchased from Infinity Pharmaceuticals. 

Lactose Monohydrate was purchased from Biocon, Bangalore, 

India. Microcrystalline Cellulose was purchased from Sigachi 

Industries. Sodium Starch Glycolate was purchased from 

Maruthi Chemicals. PVP K 30 purchased from Nabhi 

chemicals, Thane, India. Isopropyl Alcohol was purchased 

from Rankem. Purified Talc was purchased from Gangotri 

Inorganics. Magnesium Stearate was purchased from Amishi 

Drugs and Chemicals. HPMC E5 & HPMC E15 was 

purchased from Jianxin Cellulose. Xanthan Gum purchased 

from Peer Chemical Industries, Hyderabad. 

METHODOLOGY 

Pre-formulation Studies 

Standard graph preparation: Identifying the drug's lambda 

max: A 100 ml sample of ketoprofen was collected, diluted in 

100 ml of 0.1N HCl (1000µg/ml), and then 1 ml of the 

concentrated sample was made up with 6.8 pH phosphate 

buffer solution to determine the drug's lambda max.  

Calibration curve: To create the principal stock, 100 mg of 

precisely weighed medication was added to a 100 ml 

volumetric flask and topped off with 0.5N HCl (1000 mg/ml).  

__________________________________________________ 

Correspondence to: Sushma Desai, Gitam University, 

Rudraram, Patancheru, Hyderabad, Telangana, India- 502329. 

Email: d.sushmapharma@gmail.com 

T 

mailto:d.sushmapharma@gmail.com


Gandrathi et al.                                                                                              Press-Coated Pulsatile Ketoprofen Tablets 

Online First                                                                                                                      Indian J Pharm Drug Studies | 2  

Serial dilutions of that solution (1, 2, 3, 4, 5) are prepared 

and scanned under a UV lamp at λ max 260 nm. This process 

was then repeated with a 6.8 pH phosphate buffer solution and 

UV scan at λ max 262 nm and menthol at λ max 257 nm. 

The Fourier Transform Infra-Red Spectroscopic Study: 

For compatibility investigations Fourier Transform Infra-Red 

spectroscopic (FTIR) is used. For the pellet potassium 

bromide (KBr) was utilized. The ratio is (1:10). The empty 

medication was examined without any polymer as carrier, and 

in addition, drug combinations (1:1) were examined for 

formulation sample 1 mixture containing pure drug 

Ketoprofen and sample 2 containing Lactose + micro-

cellulose phosphate (MCCP) + sodium starch glycollate (SSG) 

+ polyvinyl pyrrolidone (PVP) + talc + magnesium stearate + 

ketoprofen. Sample 3 containing drug mixture with HPMC E5 

and sample 4 containing drug mixture with HPMC E15 and 

sample 5 mixture containing pure drug ketoprofen with 

xanthan gum. Moreover, structural elucidation was done. 

Solubility: The medicine ketoprofen has BCS 

(Biopharmaceutics classification system) Class II, which has a 

weak acid property, poor water solubility presents as (racemic) 

mixture and good solubility in certain organic solvents, 

according to a solubility study [25]. Using water, acetone, 

menthol, ethanol, 0.1N HCL, and 6.8 pH phosphate buffer, the 

sample was extracted and its solubility was examined. Drug 

purity assay: 100 mg of precisely weighed medication was 

added to a 100 ml volumetric flask and diluted with 6.8 pH 

phosphate buffer (1000 mg/ml). After extracting 1 milliliter of 

the sample from that solution, it was diluted in a 100-milliliter 

volumetric flask and examined under a UV lamp at λ max 262 

nm. Additionally, the standard sample and this sample were 

contrasted (identified the difference between the sample and 

standard/reference sample). 

Preparation of Ketoprofen tablet: To create a well-

distributed mixture, the powdered ketoprofen, lactose, MCCP 

pH 102, and sodium starch glycolate were run through a 

210µm sieve and then thoroughly combined using a pestle and 

mortar. With constant stirring, a PVP K 30 alcoholic solution 

should be added to the mixture dropwise. Lubricating should 

be followed by compacting the resulting powdery 

combinations. A conventional oven was used to dry the 

granules for six hours at 60ºC. Using a traditional single 

punch press, the dried granules with a size of 25–60 mesh 

were compacted into tablets after talc and magnesium stearate 

were added as a lubricant [7]. 

Pre-compression Studies 

Angle of repose: After filling a funnel to overflowing, the 

produced grains were allowed to pass through the opening 

under the influence of gravity. The height (h) and the radius (r) 

of the pile was determined from the cone that formed on a 

graph sheet, which was used to estimate the pile's area [7]. 

Repose angle = tan-1 (h/r) 

Bulk Density (BD): Twenty grams of precisely weighed 

grains were added to a 50 ml measuring cylinder. After the 

first volume (V0) was measured and determined [12]. 

Density of bulk = M/V0 

Tapped Density (TD): The grains in the measurement 

cylinder were tapped 100 times. We measured and determined 

the cylinder's minimal volume (Vt). M/Vt is the tapped 

density. The Hausner's ratio. In order to determine Hanuser's 

ratio, bulk density and tapped density were used. Hausner's 

ratio = BD – TD [13]. 

Carr's index (CI) or compressibility index (CI): The tapped 

density and bulk density were used to calculate and assess the 

compressibility index [16]. 

 CI=(TD-BD)/TD x 100 

Ketoprofen pulsatile drug delivery tablet preparation: 400 

mg of polymer (HPMC E5, HPMC E15, Xanthan Gum) and in 

combination {HPMC E5 and xanthan gum (1:1 and 3:1), 

HPMC E5 and HPMC E15 (1:1), HPMC E15.  xanthan gum 

(1:1, 2:1, and 3:1)} were removed from the punched tablets, 

which were used as cores. Two phases were employed when 

using polymer: first, 200 mg of coating polymer was poured 

into the die, then cores were placed in the middle of the die 

and slightly pushed to secure the coatings under and around 

the core. Finally, the remaining coatings were filled and 

compressed [19]. 

 

Table 1:  Formulation of ketoprofen tablets: 

Materials F1 F2 F3 F4 F5 F6 F7 F8 F9 

Ketoprofen 75mg 75mg 75mg 75mg 75mg 75mg 75mg 75mg 75mg 

Lactose 18mg 18mg 18mg 18mg 18mg 18mg 18mg 18mg 18mg 

MCCP pH 

102 

55.73mg 55.73mg 55.73mg 55.73mg 55.73mg 55.73mg 55.73mg 55.73mg 55.73mg 

SSG 18mg 18mg 18mg 18mg 18mg 18mg 18mg 18mg 18mg 

PVP 

solution 

Q.s Q.s Q.s Q.s Q.s Q.s Q.s Q.s Q.s 

Talc 1mg 1mg 1mg 1mg 1mg 1mg 1mg 1mg 1mg 



Gandrathi et al.                                                                                              Press-Coated Pulsatile Ketoprofen Tablets 

Online First                                                                                                                      Indian J Pharm Drug Studies | 3  

Magnesium 

Stearate 

1mg 1mg 1mg 1mg 1mg 1mg 1mg 1mg 1mg 

HPMC E5 400mg - - 200mg - 200mg - - 300mg 

HPMC E15 - 400mg - - 200mg 200mg 250mg 300mg - 

Xanthan 

gum 

- - 400mg 200 mg 200mg - 150mg 100mg 100mg 

 

Post compression studies: From each formulation, ten tablets 

were chosen at random, and each tablet's thickness was 

measured with a vernier caliper. The standard deviation was 

also computed. Test of Friability: Using Tablet Friabilator test 

apparatus, the friability of tablets was assessed. Initially ten 

tablets were first weighed (W initial), they were put into a 

friabilator. The friabilator was run for four minutes at 25 rpm 

or until it reached 100 revolutions. Weighing the tablets after 

the friabilation as (W final).  friability was then determined. 

Tablets with less than 1% friability are deemed acceptable 

[21].  

In vitro studies: The drug release of ketoprofen from the 

produced pulsatile tablets was investigated using an eight-

station dissolving rate testing device with a revolving paddle 

at 50 rpm and 25 cm depth in 0.1N HCl for two hours and in 

phosphate buffer pH 6.8 (900ml) for four hours. A constant 

temperature of 37.5ºC was maintained during the dissolving 

process. samples are taken out each at 1hr interval. Using a 

Ultra Violet (UV) visible spectrophotometer, the drawn 

samples are measured at 262 nm with 6.8 pH phosphate buffer 

as reference [21]. 

Stability Studies: optimized Formulation F8, underwent 

accelerated stability testing over a two-month period at 40°C ± 

2°C and 75% ± 5% Relative Humidity (RH). Dissolution and 

content uniformity tests were also conducted [21]. 

RESULTS & DISCUSSION 

Using various polymers (HPMC E5, HPMC E15, Xanthan 

gum) and a combination of synthetic and natural polymers 

(HPMC E5 and xanthan gum (1:1 and 3:1), HPMC E5 and 

HPMC E15 (1:1), HPMC E15 and xanthan gum (1:1, 2:1, and 

3:1)), the current study aims to formulate and evaluate 

Ketoprofen pulsatile tablets. 

Determination of lambda max: 

 

Fig 1: Determination of lambda max of Ketoprofen Drug 

Construction of calibration curve: 

Table 2:  Construction of Calibration curve of Ketoprofen 

S.no Concentration Absorbance in 

0.1N Hcl 

Absorbance in 6.8 pH 

Phosphate buffer 

1 10 0.098 0.113 

2 20 0.191 0.240 

3 30 0.293 0.352 

4 40 0.398 0.456 

5 50 0.487 0.545 

 

 

Fig 2: Calibration curve of Ketoprofen in 0.1N Hcl 

 

 

Fig 3: Calibration curve of Ketoprofen in 6.8 pH 

Phosphate buffer 



Gandrathi et al.                                                                                              Press-Coated Pulsatile Ketoprofen Tablets 

Online First                                                                                                                      Indian J Pharm Drug Studies | 4  

Compatibility studies: 

 

Fig 4: FT-IR of Ketoprofen 

 

 

Fig 5: FT-IR of Ketoprofen+ Lactose+ MCCP+SSG+PVP K 30+ Talc + Mg stearate 



Gandrathi et al.                                                                                              Press-Coated Pulsatile Ketoprofen Tablets 

Online First                                                                                                                      Indian J Pharm Drug Studies | 5  

 

Fig 6: FT-IR of Ketoprofen +HPMC E5 

 

 

Fig 7: FT-IR of Ketoprofen +HPMC E15 



Gandrathi et al.                                                                                              Press-Coated Pulsatile Ketoprofen Tablets 

Online First                                                                                                                      Indian J Pharm Drug Studies | 6  

 

Fig 8: FT-IR of Ketoprofen + Xanthan gum 

 

The FTIR analysis, which was conducted to identify and 

assess the compatibility of the drug and excipients, revealed 

no notable alterations in the powder combination of the drug 

and excipients. For the formulation development, the 

following excipients were chosen: lactose, MCCP, SSG, PVP, 

talc, magnesium stearate, and polymers: HPMC E5, HPMC 

E15, and xanthan gum. 

Solubility studies: 

Table 3: Solubility of Ketoprofen 

SOLVENT SOLUBILITY 

Water Practically insoluble 

Acetone Soluble 

Methanol Slightly soluble 

Ethanol Soluble 

0.1N Hcl Sparingly soluble 

pH 6.8 phosphate buffer Soluble 

It was determined that the organoleptic characteristics and 

solubility of ketoprofen found highly soluble in acetone, 

ethanol. 

Assay: 

Table 4: Study the purity of drug 

Method 1 2 3 Avg 

Spectrophotometric 

 

method 

99.96% 100.1% 99.98% 100.01% 

Limits: ≤ 99 % - ≥100.5% 

Pre-compression Studies  

Table 5: Angle of Repose, Bulk density, Tapped Density, Hausner’s ratio, Compressibility Index 

S.no Angle of 

 

repose (θ) 

Bulk density 

 

(gm/ml) 

Tapped density 

 

(gm/ml) 

Hausner’s 

 

ratio 

Compressibility 

 

Index (%) 

1 24.680 ± 0.47 0.432 ± 0.004 0.480 ± 0.005 1.112 ± 0.0119 10.067 ± 0.97 

All the values are expressed as mean ± SD n=3 



Gandrathi et al.                                                                                              Press-Coated Pulsatile Ketoprofen Tablets 

Online First                                                                                                                      Indian J Pharm Drug Studies | 7  

Research on compatibility, solubility, and organoleptic characteristics was done and the results were satisfactory. Angle of repose and 

compressibility index were determined to be within the range by pre-formulation investigations of core tablet granules, demonstrating 

excellent flow properties for compression. 

Post compression Studies 

Table 6: Thickness, Diameter, Hardness, Friability and weight variation of optimized tablet 

S.no Thickness 

 

(mm) 

Diameter 

 

(mm) 

Hardness 

(kg/cm2) 

Friability (%) Weight 

 

variation(mg) 

1 3.013 ± 0.009 8.005 ± 0.007 9.9 ± 0.316 0.01 0.185 ± 0.003 

All the values are expressed as mean ± SD. n=10 For thickness, diameter and weight variation. 

 Hence for hardness n=5, for friability n=1  

Post compression studies of coated tablet 

Table 7: Thickness, Diameter, Hardness, Friability, and weight variation  

Formulation Thickness 

 

(mm) 

Diameter (mm) Hardness 

(kg/cm2) 

Friability 

 

(%) 

Weight 

 

variation(mg) 

F1 3.79 ± 0.03 12.86 ± 0.008 16.9 ± 0.31 0.02 594.6 ± 2.10 

F2 3.81± 0.006 12.32± 0.006 17.0 ±0.3 0.01 595.2 ± 1.469 

F3 3.87 ± 0.006 12.867 ± 0.04 6.1 ± 0.3 0.04 595.2 ± 2.18 

F4 3.748 ± 0.007 12.931 ± 0.005 16.9 ± 0.3 0.03 595.4 ± 1.624 

F5 3.815 ± 0.006 12.983 ± 0.006 14.1 ± 0.3 0.04 594.6 ± 1.854 

F6 3.893 ± 0.007 12.883 ± 0.06 15.9 ± 0.3 0.04 594.8 ±1.939 

F7 3.847 ± 0.006 12.963 ± 0.004 16.9 ± 0.3 0.02 596.2 ± 1.66 

F8 3.863 ± 0.004 12.863 ± 0.004 16.9 ± 0.3 0.01 597.4 ± 1.113 

F9 3.851 ± 0.005 12.944 ± 0.004 17.0 ± 0.3 0.01 593.3 ± 1.676 

 

A powder mix was assessed for the pre-formulation 

investigations, which included Hausner's ratio (1.112 

±0.0119), compressibility index (10.067 ± 0.97), bulk density 

(0.432 ±0.004), taped density (0.480 ±0.005), and angle of 

repose (24.680 ± 0.47). The powder was then punched as 

tablets. The formulation core tablet's angle of repose and 

compressibility index (Carr's index) were determined to be 

within the range, demonstrating excellent compression flow 

properties. The core tablet underwent evaluation trials that 

included friability of 0.01%, hardness of 9.9 ± 0.316 kg/cm2, 

weight variation (mg) of -0.185 ± 0.003 falling within 2%, and 

content uniformity of 103.08 %, which conforms with not less 

than (NLT) 90.0% to not more than (NMT) 110.0% of the 

label claim. Following assessment tests of the core tablet, the 

tablet was press-coated utilizing coating materials HPMC E5, 

HPMC E15, and xanthan gum. Thus, evaluation tests for 

weight fluctuation, hardness, and friability of press-coated 

tablets were conducted and produced positive findings. 

In vitro studies: 

 

Fig: 9: Invitro studies graph of F1, F2, F3 formulations 

 

Fig10: In-vitro studies graph of F4, F5, F6 formulation 



Gandrathi et al.                                                                                              Press-Coated Pulsatile Ketoprofen Tablets 

Online First                                                                                                                      Indian J Pharm Drug Studies | 8  

 

Fig 11: In-vitro studies graph of F7, F8, F9 formulations 

In vitro dissolving tests were conducted on formulations F1 

through F9, whereas formulation 8 provided a 6-hour pulsatile 

release of the medication. In this case, the medicine was 

released entirely after the allotted period, indicating that the 

formulation was deemed satisfactory. For stability 

investigations, F8 was chosen based on in vitro release tests.  

Stability studies: For stability investigations, F8 was chosen 

based on in vitro release tests. The formulation 8 (F8), which 

has a 3:1 ratio of natural polymer (xanthan gum) to synthetic 

polymer (HPMC E15), exhibits a pulsatile drug release in 6 

hours, according to drug release experiments and after two 

months of accelerated trials, the F8 formulation was 

discovered to be stable. 

Accelerated studies: (40⁰C ± 2⁰C & 75%±5% RH) 

Table 8: Stability studies data for the optimized 

formulation 

S.no

  

   

 

Test  

parameters 

Optimized formulation 

1st month 2nd month 

1.  Appearance  Almost white 

colour  

Almost white 

colour 

2.  Drug content  102.98% 102.91% 

3.  Dissolution  At the end of 6th hr 
released 
completely 

At the end of 
6th hr released 
completely 

The stability study was conducted for two months at 40°C ± 

2°C and 75% relative humidity ± 5% ACS (Accelerated 

Stability Studies) in accordance with ICH recommendations. 

During the study time, tablets were assessed for assay and in 

vitro dissolving research, and no notable alterations were 

observed. 

SUMMARY 

Ketoprofen pulsatile tablets were developed and evaluated in 

this work utilizing a variety of polymers, including synthetic 

and natural polymers. The core tablet underwent evaluation 

procedures that examined content homogeneity compliance, 

weight fluctuation within SD±2%, hardness, and friability. 

Evaluations of coated tablets show that the weight fluctuation, 

hardness, and friability all fall within SD±2%. In vitro 

dissolving tests were conducted on formulations F1 through 

F9, and at the conclusion of the sixth hour, formulation 8 

produced a pulsatile drug release. After the allotted period, the 

medication was released here at once. The stability study, 

which was conducted for two months for formulation 8 in 

accordance with ICH requirements, was determined to be 

stable. 

CONCLUSION 

Although controlled and sustained drug delivery systems have 

been widely used and successful in the medical field, pulsatile 

systems can be helpful for providing medications in line with 

the circadian behavior of diseases. There is always a need for 

new delivery systems to give patients additional therapeutic 

benefits. One such technique, pulsatile medicine 

administration, which administers medications at the 

appropriate time, place, and dose, has the potential to benefit 

patients with chronic illnesses such arthritis (rheumatoid 

arthritis) mostly affects women globally.    

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How to cite this article: Gandrathi S, kumar PN, Baru CR, 

Desai S, M. Shiroja, Swetha R. Design and Development of 

Press Coated Pulsatile Release of Ketoprofen Tablets. Indian J 

Pharm Drug Studies. 2025; Online First. 

Funding: None;                 Conflicts of Interest: None Stated 

 

 

 


