Formulation and evaluation of stomach specific mucoadhesive tablets of

famotidine

Aim of present investigation

Famotidine is a histamine H2-receptor antagonist. It is widely prescribed in gastric ulcers, duodenal

ulcers, Zollinger-Ellison syndrome and gastroesophageal reflux disease. In the management of benign
gastric and duodenal ulceration the dose is 40 mg daily by mouth at bedtime, for 4 to 8 weeks. In
gastroesophageal reflux disease the recommended dose is 20 mg by mouth twice daily for 6 to 12
weeks; where gastroesophageal reflux disease is associated with esophageal ulceration, the
recommended dosage is 40 mg twice daily for a similar period. For the short term symptomatic relief
of heartburn or non-ulcer dyspepsia a dose of 10 mg up to twice daily is suggested. In the Zollinger-
Ellision syndrome the initial dose by mouth is 20 mg every 6 hrs, increased as necessary; dose up to
80 mg daily have been employed 1. Its low bioavailability (40-45%) and short biological half-life (2.5-
4.0 hrs) following oral administration favors development of a sustained release formulation.

The gastroretentive drug delivery systems can be retained in the stomach and contribute in improving
the oral sustained delivery of drugs that have an absorption window in a particular region of the
gastrointestinal tract. These systems help in continuously releasing the drug before it reaches the
absorption window, thus ensuring optimal bioavailability 2. It has been reported that the oral
treatment of gastric disorders with an H2 receptor antagonist like famotidine or ranitidine used in
combination with antacids promotes local delivery of these drugs to the receptor of parietal cell wall.
Local delivery also increases the stomach wall receptor site bioavailability and increases efficacy of
drugs to reduce acid secretion. Hence this principle may be applied for improving systemic as well as
local delivery of famotidine, which would efficiently reduce gastric acid secretion 3.

There are a number of approaches that can be used to prolong gastric retention time, like these include
floating drug delivery systems, also known as hydrodynamically balanced systems, swelling and
expanding systems, polymeric bioadhesive systems, modified-shape systems, high-density systems,
and other delayed gastric emptying devices 4-10. A floating drug delivery system, being less dense than
gastric juice due to the incorporation of at least one porous structural element was described 11.
Recently, research has been done using famotidine as an effervescent type drug delivery system 12.
Also, a new type of multiparticulate floating drug delivery system consisting of a highly porous
carrier material (foam powder), drug and polymer: low density microparticles have been proposed 13-
14
.

The aim of this work was the study of new mucoadhesive stomach-specific tablets, realized by
mucoadhesive and swellable polymers, in order to increase famotidine residence time and to control
its topical delivery. Furthermore, the design of this type of swellable drug delivery systems (SDDS) is
rather sophisticated because of the necessity to impart two specific properties to the system, i.e.
immobilization and controlled release characteristics. Among many kinds of immobilized SDDS 15-16,
monolithic tablets were considered because of the possibility of manufacture using
conventional techniques and their ability to hold large amounts of drug.
This goal can also be achieved using mucoadhesive polymers with different physicochemical and
mechanical properties. In this study a modified chitosan, mixed with a synthetic bioadhesive polymer,
such as polivinylpyirrolidone (PVPK90) or polycarbophil (PCPAA1) was employed and investigated.

Chitosan is a hydrolyzed polysaccharide (deacetylated) derivative of chitin, a biopolymer widespread

in nature, that is non-toxic, biocompatible and biodegradable 17. It is reported to show antibacterial
activity 18-20 and penetration enhancement properties towards pluristratified epithelia by improving the
transport of hydrophilic drugs through monostratified mucosa containing tight junctions 21. In addition
it has many other properties useful for pharmaceutical applications 22 and, for these reasons, largely
employed to prepare buccal and vaginal mucoadhesive dosage forms 23-28. The presence of
OH and NH2 groups, together with its cationic character, allows the establishment of hydrogen
bonding with mucin chains, resulting in a good mucoadhesive character 22. So, chitosan appeared to be
an excellent candidate to prepare formulations applicable on a mucin surface, rich in numerous folds
and microridges.

Chitosan polymers have been sporadically used for tableting 29 however, to date, no detailed
compression and compaction characterizations exist and, generally, it necessitates the addition of
other ingredients to facilitate compression30.

In this study, the chitosan derivative FG90 was employed. It is a highly deacetylated chitosan (degree
of deacetylation 99.97%) with good tableting properties and suitable to obtain highly mechanically
stable tablets29.

Experimental

Materials

Famotidine was gifted by Torrent Pharmaceuticals Pvt. Ltd (Chhatral, India). Polycarbophil
AA1®NOVEON (PCPAA1) (from Noveon Inc., USA) MW > 106; polyvinylpyrrolidone PLASDONE
K90 (PVPK90) (from ISP Tecnologies Inc., Wayne, NJ), MW 1.3 × 106 and chitosan (FG90C), a food
grade chitosan (manufactured by Primex, Drammen, Norway from shrimp shells and distributed by
Faravelli, Milano, Italy) degree of acetylation 0.03%, average MW 100 kDa, viscosity of 1% solution
in 1% acetic acid 110 mPa s, ashes 0.3%, were used as mucoadhesive polymers for
tablet preparation.

Estimation of famotidine

A solution of Famotidine was prepared in 0.1 N HCl and Phosphate buffer pH 4.5 and UV
spectrum was taken using Shimadzu UV-1601 UV/Vis double beam Spectrophotometer
(Kyoto, Japan), The UV maxima of Famotidine was found to be 265 nm in 0.1 N HCl and
also same in Phosphate buffer pH 4.5
The results of standard curve preparation are shown in Figure 5.1.
 1
0.8

Absorbance
0.6
0.4
0.2
0
0 5 10 15 20 25
Conc(mcg/ml)

Figure 1: Standard curve of famotidine in 0.1 N HCl

The results of standard curve preparation are shown in Figure 2.

1
0.8
Absorbance

0.6
0.4
0.2
0
0 5 10 15 20 25
Conc(mcg/ml)

Figure 2: Preparation of standard curve of famotidine in phosphate buffer (pH 4.5)

Manufacturing of tablets

A homogeneous physical blend of polymers (200 mg) and famotidine (40 mg) was gently prepared by
using a pestle and mortar and then compressed, by a 13 mm diameter die on an single-punch, manual
hydraulic press (Cadmach, India) 24-25, using a compression force of 1 × 103 kg for a total time of 10 s.
Tablet thickness was measured (n = 5) by a micrometer (Borletti, Milano, Italy) (Table 3).
Table 3: Characterization of tablets

Tablet Polymer composition (mg) Thickness Crushing Friability Ex vivo Ex vivo

s (mm ± SD strength force (% ± SD) mucoadhesio mucoadhesiv
PVPK9 FG90C PCPAA ) (n = 5) (N ± SD) (n = 20) n time e force
0 ratio ratio 1 ratio (n = 10) (h ± SD) (N ± SD)
(mg) (mg) (mg) (n = 3) (n = 3)

G1 2 1 - 1.46 ± 0.04 135.00 ± 10.1 0.127 ± 0.06 23 ± 0.15 1.35 ± 0.01

(133.33) (66.66) 0 7

G2 1 (100) 1 (100) - 1.43 ± 0.04 93.00 ± 15.50 0.229 ± 0.03 24 ± 0.20 0.96 ± 0.13

3

G3 1 (66.66) 2 - 1.37 ± 0.02 90.00 ± 12.23 0.310 ± 0.04 24 ± 0.20 1.46 ± 0.14

(133.33 5
)

G4 - 1 2 1.35 ± 0.03 140.00 ± 6.54 0.050 ± 0.01 28 ± 0.35 1.51 ± 0.02

(66.66) (133.33) 1

G5 - 1 (100) 1 (100) 1.30 ± 0.03 137.00 ± 9.09 0.057 ± 0.01 >75 1.52 ± 0.16

5

G6 - 2 1 (66.66) 1.27 ± 0.03 129.00 ± 11.3 0.042 ± 0.01 22 ± 0.25 1.10 ± 0.07

(133.33 5 7
)

Physical characterization: crushing strength

The crushing strength was analyzed, according to the Indian Pharmacopoeia using a hardness tester
(Pfizer hardness tester). Data are reported as an average of 10 measurements and the error expressed
as SD (Table 3).

Physical characterization: friability

Friability was determined according to IP 96 by submitting 20 previously weighed tablets to falling

shocks for 4 min in an friabilator (Labtronics, India), set at 25 rev/min. After 4 min, the tablets were
reweighed and the percentage friability was calculated (Table 3).

Swelling studies

Tablet swelling properties (%) and erosion characteristics, matrix erosion or dissolution (DS) were
evaluated as previous reported 31. These experiments were performed in triplicate and data were
calculated using the following Equations (1) and (2):

[1]
 [2]

Table 4: % Hydration of tablets G1-G6

Time (hrs) % Hydration

G1 G2 G3 G4 G5 G6
0.5 51.5 55 57 58 67 75.65

1 61 65 66 63 87 82

2 70 72 76 78 83 90

3 75 73 77 80 85 91

4 71 75 77 81 86 92

5 68 76 78 83 87 92

10 65 77 79 84 88 92

15 63 77 80 85 88 92

20 60 78 80 88 90 93

25 54 81 84 91 92 94

100
80
60
40
20
0
0.5 1 2 G13 4 G25 10 G3
15 20 25
G4 G5 G6
 Figure 3: % Hydration of tablets G1-G6

Ex vivo mucoadhesion time and behaviour

Ex vivo mucoadhesion times were detected (triplicate) after application of tablets on fresh cut rat
stomach mucosa 32. Tablet behaviour and mucoadhesive times were monitored until complete
detachment or dissolution occurred (Table 3).

Ex vivo mucoadhesion force

Ex vivo adhesion strength (expressed as force required to remove a tablet from rat stomach mucosa)
of tablets was assessed in simulated gastric environment 33-34 using a modified physical balance.
Measurements started after 3 min from tablet application; the maximum adhesive forces are the
expression of the average of three measurements (n = 3) and the confidence interval was determined
at 0.05 significance level (Table 3).

In vitro drug release studies

The drug release study was performed using USP XXIV basket apparatus (Electrolab, TDT-06T,
Mumbai, India) at 37oC ± 0.5oC and at 50 rpm using 900 mL of 0.1 N HCL (pH 1.2) as a dissolution
medium (n = 5) as per USP XXVI dissolution test prescribed for famotidine.

In vitro release mathematical model

In vitro release data were submitted to statistical investigation. All tablet release profiles were fitted to
the Ritger and Peppas's 35 kinetics mathematical model Mt/M∞ = Ktn, applied to swellable matrices, in
order to investigate what mechanism causing for famotidine release from its diffusional exponent
evaluation.

Table 5: Ritger and Peppas's kinetic mathematical model and first order kinetics model fitting

Mt/M∞ = Ktn G1 G2 G3 G4 G5 G6
y = 5.244x  y = 5.2062x  y = 3.8809x  y = 3.893x y = 4.2248x  y = 3.4218x
n = 1
+ 11.055 + 12.689 + 14.364  − 14.519 + 3.3466  + 4.9467
r = 0.9795 r = 0.9418 r = 0.9521 r = 0.9768
r = 0.9818 r = 0.9942

y = 7.0186x  y = 7.0437x  y = 5.3818x  y = 3.893x  y = 5.8652x y = 4.748x 

n = 0.9
+ 8.4957 + 9.8176 + 11.641 − 14.519  + 0.4487 + 2.6177
r = 0.9862 r = 0.9528 r = 0.9626 r = 0.9768
r = 0.9852 r = 0.9972

y = 9.432x  y = 9.5689x  y = 7.4949x  y = 9.2565x  y = 8.1724x  y = 6.6138x 

n = 0.8
+ 5.4012 + 6.3489 + 8.3518 + 3.5814 − 3.0352 − 0.191
r = 0.9918 r = 0.9629 r = 0.9722 r = 0.9683
r = 0.9871 r = 0.9988
 y = 1.397x  y = 18.555x  y = 14.855x  y = 3.893x  y = 16.182x  y = 13.097x 
n = 0.6
− 0.3911 − 4.4361 − 0.9839 − 14.519 − 12.867 − 8.1529
r = 0.9978 r = 0.9801 r = 0.9871 r = 0.9768
r = 0.9843 r = 0.9961

y = 20.423x  y = 21.289x  y = 17.756x y = 21.339x  y = 19.328x y = 15.647x

n = 0.55
− 6.4618 − 6.9019  − 4.2399 − 10.649 − 16.29  − 10.932
r = 0.9978 r = 0.9807 r = 0.9896 r = 0.9818
r = 0.9819 r = 0.9938

y = 24.088x  y = 25.244x y = 21.322x  y = 25.48x y = 23.19x  y = 18.778x

n = 0.5
− 10.086  − 10.936 − 8.0795  − 14.976 − 20.325  − 14.212
r = 0.9971 r = 0.9823 r = 0.9913 r = 0.9825 r = 0.9907
r = 0.9785

Results and discussion

The aim of this study was the design of mucoadhesive stomach-specific tablets by using, as a matrix,
a mixture of deacetylated chitosan and synthetic polymers, having improved performances if
compared to traditional formulations employed in BV therapy.

Manufacturing of tablets and technological assays

Six kinds of tablets were prepared by using different mucoadhesive polymer percentages as shown in
Table 3. Each tablet contains FG90C mixed, in different ratios, to PVPK90 (tablets G1–G3) or to
PCPAA1 (tablets G4–G6). Observing tablet thickness values (Table 3), it is possible to note that their
width is mainly affected by the amounts of the synthetic polymer. The hardness test (Table 3) showed
that tablets had a crushing strength range between 90.00 and 140.00 N. Friability tests were performed
according to the specific monograph of the IP and 20 tablets were tested by using a friabilator and
were observed at predetermined time: if none of these is cracked or broken, all tablets, after re-
weighting, must show a mass loss less than 1%.

Swelling studies

All tablets swelled quickly with high hydration percentage (51.5–75.65%) after only 30 min, reaching
values between 70 and 90% after 2 h. It was clearly evident that tablets G4–G6 (PCPAA1/FG90C)
hydrated more and faster than tablets G1–G3 attaining the maximum of hydration in 2 h, while the
latter (PVPK90/FG90C) hydrated very slowly showing hydration <60% after 30 min.

Ex vivo mucoadhesion time and behaviour

Ex vivo mucoadhesive tests were performed in order to evaluate tablet residence time on the
application site, to observe tablet behaviour when in contact to mucosal surface and gastric fluid, and
to identify a formulation able to avoid numerous daily administrations.

All kinds of tablets adhered immediately to mucosal surface and showed high adhesion times (22–
75 hrs), but tablets G4–G6 had more prolonged times than G1–G3.
Ex vivo mucoadhesion force

All tablets showed good mucoadhesive forces with values ranging between 0.96 and 1.52 N (Table 3).

In this case, no exact relationships between bioadhesion force and polymer blends could be drawn.
Tablets G3–G5 resulted to have the strongest adhesivity.

In vitro drug release studies

Tablets G1–G3 released only up to 80% of famotidine in 12 hrs. Release profiles were very similar
and practically overlapped for the first 4 hrs. After this period, it was possible to note a small
difference: tablet G2 (PVPK90/FG90C ratio 1:1) drug release slightly increased (6–8 hrs).

Tablets G4–G6 behaviors were less uniform than G1–G3. The percentage of drug released was
proportional to PCPAA1 content in the polymer blend. Famotidine release from tablet G4
(PCPAA1:FG90C 2:1), in fact, was most rapid, reaching 63.0% after 8 hrs, 79.0% after 11 hrs and the
maximum of 90.0% after 15 hrs.

Release profiles of tablets G5 and G6 were overlapped for the first 10 hrs. After this time, tablet G6
(PCPAA1:FG90C 1:2) showed the lowest profile, while tablet G5 (PCPAA1/FG90C 1:1) had an
intermediate behavior between G6 and G4.

Finally, tablets presenting highest drug release were those based on PCPAA1/FG90C blend,
confirming mucoadhesion time and behavior tests, because of high swelling due to PCPPA1 presence.

In vitro release mathematical model

Analysis data showed that the 1th group of tablets, had two kinds of kinetics. In the case of tablet G1,
the best fitting (r = 0.9978) was found for n value 0.6 and 0.55 indicating an anomalous release
mechanism. Table 3, in fact, proved the highest DS values. When chitosan content increased in the
blend, an additional release mechanism was observed. Tablets G2 and G3 showed highest r value for
n = 0.5, meaning that drug release depended on the square time (Higuchi kinetic for tablet G3). This
demonstrates that the liquid penetration rate constitutes the main process and that drug can easily
diffuse among polymeric network of gelled phase.

The 2nd group of tablets, G4, G5 and G6, showed different release profiles and mechanisms. Tablet
G4, containing the highest amount of PCPAA1 and presenting a very high hydration level, released
the drug mainly through a diffusion mechanism (r = 0.9825, n = 0.5). When chitosan content
increased, polymeric chain relaxation process affected drug diffusion and the n value increased: 0.8
for tablet G5 (r = 0.9871) and tablet G6 (r = 0.9988).

Conclusion

It is possible to assess that FG90C is a suitable polymer to realize mucoadhesive SDDS. In order to
prepare good tablets, chitosan must be blended with other polymers (PVPK90 or PCPAA1) because
its direct compression is not achievable. All polymer mixtures employed were useful to prepare
tablets; polymer–polymer and drug–polymer negative interactions were not observed. In this context
and in consideration of high in vitro adhesion time (28 hrs) and controlled release presented, tablet G4
has been considered the best formulation.
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In this study, a new dosage form, containing famotidine, was developed with the aim to realize
stomach-specific mucoadhesive tablets by including mucooadhesive polymers as chitosan (FG90C),
polyvinylpyrrolidone (PVPK90) and polycarbophil (PCPAA1), blended in different ratios. All
formulations were characterized by studies of friability, hardness, hydration, mucoadhesion, in vitro
release and release mechanism. FG90C performances improved in particular when mixed to PCPAA1
(1:2 ratio). This kind of delivery system is suitable for formulating famotidine for stomach-specific
prolong sustained delivery.