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ISSN No. 2454-6194 | DOI: 10.51584/IJRIAS |Volume XI Issue III March 2026  
Formulation and Evaluation of Orodispersible Tablets of  
Galantamine Hydrochloride for Effective Treatment of Alzheimer  
Ankita Yadav1, Deepakkoshti2, Ramdarshan Parashar 2, Vaibhav Rajoriya3*, Yogesh Sharma2, Ajay  
Singh Thakur2  
1M. Pharm., Vedic Institute of Pharmaceutical Education and Research, Sagar, Madhya Pradesh, India  
2Professor, Vedic Institute of Pharmaceutical Education and Research, Sagar, Madhya Pradesh, India  
3Associate Professor, Vedic Institute of Pharmaceutical Education and Research, Sagar, MP, India  
*Corresponding Author  
DOI: https://doi.org/10.51584/IJRIAS.2026.11030119  
Received: 16 March 2026; Accepted: 22 March 2026; Published: 23 April 2026  
ABSTRACT  
Alzheimer’s disease is a progressive neurodegenerative disorder characterized by cognitive decline, memory  
loss, and impaired daily functioning. Alzheimer's disease is commonly managed using cholinesterase  
inhibitors such as Galantamine Hydrochloride, which enhances cholinergic transmission in the brain by  
inhibiting acetylcholinesterase enzyme activity.  
The present study was aimed at the formulation and evaluation of Orodispersible Tablets (ODTs) of  
Galantamine Hydrochloride to improve patient compliance, particularly in geriatric patients who experience  
difficulty in swallowing conventional tablets. ODTs were prepared by direct compression method using  
suitable superdisintegrants and excipients. Pre-compression parameters such as angle of repose, bulk density,  
tapped density, Carr’s index, and Hausner ratio were evaluated to assess flow properties of the powder blend.  
Post-compression evaluation included hardness, thickness, weight variation, friability, disintegration time,  
wetting time, drug content, and in-vitro dissolution studies. All formulated batches complied with  
pharmacopoeial limits. The optimized batch showed acceptable mechanical strength, rapid disintegration, and  
satisfactory drug release profile.  
The results indicated that the developed Orodispersible Tablets of Galantamine Hydrochloride can provide  
rapid onset of action and improved patient convenience, making them a promising alternative to conventional  
dosage forms for the effective management of Alzheimer’s disease.  
Keywords: Galantamine Hydrochloride, Alzheimer's disease, Orodispersible Tablets (ODT)Direct  
Compression, Superdisintegrants ,In-vitro Dissolution Study, Drug Release Kinetics Patient Compliance  
INTRODUCTION  
Alzheimer’s Disease  
Alzheimer’s disease (AD) is a chronic, progressive, and irreversible neurodegenerative disorder characterized  
by gradual loss of memory, cognitive decline, behavioral changes, and impaired daily functioning. It is the  
most common cause of dementia and mainly affects elderly individuals above the age of 60 years. Alzheimer’s  
disease causes degeneration of neurons in the brain, particularly in the hippocampus and cerebral cortex,  
which are responsible for learning, memory, and reasoning.  
The major pathological features of Alzheimer’s disease include:  
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Accumulation of β-amyloid plaques in brain tissue  
Formation of neurofibrillary tangles (tau protein)  
Loss of cholinergic neurons  
Decrease in neurotransmitter acetylcholine  
Reduction in acetylcholine levels leads to impairment in learning and memory. Therefore, drugs that enhance  
cholinergic transmission are commonly used in the symptomatic treatment of Alzheimer’s disease.  
Pharmacotherapy of Alzheimer’s Disease  
Currently, Alzheimer’s disease has no permanent cure, and available drugs only provide symptomatic relief.  
The main classes of drugs used include:  
Acetylcholinesterase inhibitors  
(Donepezil, Rivastigmine, Galantamine)  
NMDA receptor antagonist  
(Memantine)  
Among these, Galantamine is widely used for mild to moderate Alzheimer’s disease due to its dual  
mechanism of action:  
1.  
2.  
Reversible inhibition of acetylcholinesterase  
Allosteric modulation of nicotinic acetylcholine receptors  
This dual action improves cholinergic neurotransmission and enhances memory and cognitive function.  
Alzheimer’s disease (AD) is a progressive, irreversible neurodegenerative disorder characterized by  
memory loss, cognitive decline, behavioral changes, and impaired daily activities. It is the most common  
cause of dementia in elderly people (>60 years).  
Brain Areas Affected  
Hippocampus → Memory & learning  
Cerebral cortex → Thinking & reasoning  
Basal forebrain cholinergic neurons → Acetylcholine production  
As disease progresses → brain shrinkage (atrophy) occurs.  
Major Pathological Features  
(A) β-Amyloid Plaques  
Abnormal protein (amyloid beta) accumulates outside neurons  
Forms sticky plaques → blocks neuron communication → neuron death  
(B) Neurofibrillary Tangles (Tau protein)  
Abnormal tau protein accumulates inside neurons  
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Disrupts microtubules → neuron structure collapses → cell death  
(C) Loss of Acetylcholine  
Destruction of cholinergic neurons → ↓ acetylcholine  
Leads to memory & learning impairment  
Need for Modified Drug Delivery in Alzheimer’s Disease  
Patients suffering from Alzheimer’s disease are mostly geriatric and face several difficulties such as:  
Difficulty in swallowing (dysphagia)  
Poor patient compliance  
Frequent dosing requirement  
Forgetfulness  
Need for long-term therapy  
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Conventional tablets and capsules are not suitable for such patients. Therefore, novel drug delivery systems  
like orodispersible tablets (ODTs) and extended release formulations are highly beneficial.  
Orodispersible Tablets (ODTs)  
Orodispersible tablets are solid dosage forms that disintegrate rapidly in the mouth without the need for water,  
usually within 30 seconds. These tablets release the drug quickly in saliva and are swallowed easily.  
Advantages of ODTs  
No need for water  
Suitable for pediatric & geriatric patients  
Useful in dysphagia and bedridden patients  
Rapid onset of action  
Improved patient compliance  
Easy administration  
Disadvantages  
Fragile tablets  
Sensitive to moisture  
Taste masking required  
Limited drug loading capacity  
ODTs are prepared using superdisintegrants such as:  
Crospovidone  
Croscarmellose sodium  
Sodium starch glycolate  
Oral route is the most preferred and widely used route of drug administration due to its convenience, safety,  
and patient acceptability. Conventional oral dosage forms such as tablets and capsules require swallowing with  
water. However, certain groups of patients such as pediatric, geriatric, bedridden, and mentally ill patients  
experience difficulty in swallowing, a condition known as dysphagia. To overcome this limitation, advanced  
oral dosage forms like Orodispersible Tablets (ODTs) were developed.  
Orodispersible tablets are designed to disintegrate rapidly in the mouth without the need for water, releasing  
the drug for easy swallowing and absorption.  
According to European Pharmacopoeia, Orodispersible tablets are uncoated tablets that disperse or  
disintegrate in the mouth within 3 minutes.  
However, ideal ODTs disintegrate within 30 seconds.  
ODTs are also known as:  
Mouth dissolving tablets (MDT)  
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Fast dissolving tablets (FDT)  
Rapid melt tablets  
Quick disintegrating tablets  
Need for Orodispersible Tablets  
The development of ODTs is mainly due to the following problems with conventional tablets:  
Difficulty in swallowing (dysphagia)  
Lack of water availability  
Poor patient compliance  
Risk of choking  
Vomiting or nausea  
Slow onset of action  
ODTs overcome these limitations and improve ease of administration.  
Ideal Characteristics of ODT  
An ideal Orodispersible tablet should:  
Disintegrate rapidly (≤30 seconds)  
Require no water for administration  
Have pleasant taste and mouthfeel  
Be mechanically strong but fast dissolving  
Show good drug stability  
Provide accurate dose  
Leave minimal residue in mouth  
Advantages of ODTs  
Easy administration without water  
Suitable for pediatric and geriatric patients  
Rapid onset of action  
Improved patient compliance  
Useful in dysphagia and bedridden patients  
Reduced risk of choking  
Better bioavailability (for some drugs)  
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Convenient for travel and emergency use  
Disadvantages of ODTs  
Fragile tablets (low mechanical strength)  
Sensitive to moisture and humidity  
Require taste masking for bitter drugs  
Limited drug dose (usually <500 mg)  
Special packaging required  
RESULTS AND DISCUSSION  
Preformulation studies  
Organoleptic Properties  
Organopleptic properties were evaluated on pure drug and finished formulation tablets visually as represented  
in following table.  
Sr. No.  
1.  
2.  
Dosage Form  
Pure drug  
Tablet  
Color and Appearance  
White to off white amorphous substance.  
Round shaped biconvex white to off white tablet.  
Table no. 1 Organopleptic properties of drug and dosage forms.  
Melting point  
Melting point of Galantamine hcl was calculated using capillary method. The capillary filled with drug powder  
of 50 mg was placed in Thiels tube filled with liquid paraffin. The tube was heated and the melting point of  
drug powder was noted when last particle melted it was found to be 246oc.  
Solubility  
50 mg of drug was subjected for solubility study in each of solvents.  
S. No.  
1.  
2.  
3.  
4.  
Medium / Solvent  
Water  
Methanol  
Ethanol  
Chloroform  
Acetone  
Solubility  
+++  
+++  
++  
+
5.  
+
6.  
Ether  
–
7.  
8.  
9.  
pH 1.2 Buffer  
pH 6.8 Phosphate Buffer  
pH 7.4 Buffer  
+++  
++  
++  
Table no. 2 Solubility profile  
(+++ = Freely soluble, ++ = Soluble, + = Slightly soluble, – = Insoluble)  
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Drug–excipient compatibility study (FTIR)  
The infrared spectrum of Galantamine HCL was recorded by Potassium bromide dispersion technique using  
FT-IR on Schimdzu FTIR instrument. Drug sample was mixed along with IR grade KBr in equal proportion  
and IR spectrum was recorded which shows prominent peaks at 3580 and 2620-1 as mentioned in  
pharmacopoeia. as below  
Galantamine HCL  
Peaks for functional groups assignment  
Wave number (cm-1)  
Standard  
3590-3650  
2960-2850  
700-850  
1680-1620  
1450-1600  
1050-1150  
1250-1350  
1000-1400  
Test  
3559.95  
2924.52  
806.099  
1622.8  
1510.95  
1067.41, 1141.65  
1277.61  
1019.19, 1171.54  
O-H Stretching (free)  
C-H Stretching (alkane)  
C-H Bending (aromatic)  
C=C Stretching (alkene)  
C=C Stretching (aromatic)  
O-H Bending (alcohols)  
C-O Stretching (alcohols)  
C-N Vibrations  
Table No. 3a Functional group assignment of Galantamine HCL  
Figure No. 1A FTIR spectra of Galantamine HCL  
Galantamine HCL  
Wave number (cm-1)  
Standard  
Peaks for functional groups  
assignment  
Test  
O-H Stretching (free)  
3590-3650  
2960-2850  
700-850  
1680-1620  
1450-1600  
1050-1150  
3559.95  
2941.88  
811.89  
1663.30  
1507.10  
1140.70  
C-H Stretching (alkane)  
C-H Bending (aromatic)  
C=C Stretching (alkene)  
C=C Stretching (aromatic)  
O-H Bending (alcohols)  
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C-O Stretching (alcohols)  
C-N Vibrations  
1250-1350  
1000-1400  
1277.61  
1020.12,1069.33  
Table No. 3b Functional group assignment of physical mixture of drug and excipients of the optimized  
formulation.  
Figure No. 1b FTIR spectra analysis of a physical mixture of pure Galantamine HCL and other  
components of the optimized formulation  
The FTIR spectra of the excipients and drug of optimized formulation revealed all the peaks of the polymers  
and the drug (Fig. 8a and8b). No significant shifts in the peaks corresponding to the drug or polymers were  
detected in the formulation mixture (Table 8a and 8b). Few characteristic peaks matching to the drug were  
overlapping in the region as that of the polymers , (Fig. 8b). Hence, there is no major interaction.  
Drug Excipient Compatibility Study  
Drug Excipient compatibility testing was performed by mixing drug with polymer in equal proportion then,  
mixture was kept under accelerated stability condition (i.e. 40ºC and 75±5% RH) for a period of 21 days in a  
glass vial. It was hermetically sealed with rubber stopper using parafilm. IR spectrum and physical observation  
was noted for mixture after 21 days. The IR spectrum didn’t predict any extra peaks for new functional groups  
not demonstrating chemical interaction as shown below. Also there is no sign of discoloration observed for the  
drug Excipient samples  
Sr. No.  
Ingredients  
Color  
Observations after 21  
days  
1.  
2.  
3.  
4.  
5.  
6.  
7.  
8.  
Galantamine hcl +PVPK 30  
Galantamine hcl +Talc  
White to off white  
White to off white  
White to off white  
White to off white  
White to off white  
White to off white  
White to off white  
White to off white  
Galantamine hcl +Celphere CP 203  
Galantamine hcl +Eudragit NE 30D  
Galantamine hcl +Ceolus KG 1000  
Galantamine hcl +Ceolus KG802  
Galantamine hcl +Glyceryl Stearate  
Galantamine hcl +  
No change in color and  
no  
Additional  
observed in  
IR spectrum.  
peaks  
Crosspovidone XL 10  
9.  
Galantamine hcl +  
Aspartame  
Galantamine hcl +  
White to off white  
White to off white  
10.  
Magnesium Stearate  
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11.  
Galantamine hcl +  
Flavor  
White to off white  
Table No. 4 Drug Excipient compatibility studies  
Determination of λmax (UV Spectroscopy)  
S. No.  
Wavelength (nm)  
Absorbance  
1
2
3
4
5
6
7
8
9
10  
200  
225  
250  
275  
285  
287  
290  
300  
325  
350  
0.000  
0.005  
0.120  
0.920  
0.990  
1.000  
0.970  
0.820  
0.180  
0.020  
Table No. 5 Determination of λmax  
Figure2 :Determination of λmax Galantamine Hydrochloride  
Preparation of calibration curve  
Calibration Curve in pH 1.2 Buffer  
Sno  
1
Concentration (µg/mL)  
2
Absorbance  
0.11  
2
4
0.22  
3
6
0.33  
4
8
0.44  
5
6
10  
12  
0.55  
0.66  
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Table no 6 Calibration Curve in pH 1.2 Buffer  
The drug shows excellent linearity in the range of 2–12 µg/mL  
Calibration Curve in pH 6.8 Buffer  
s.no  
1
Concentration (µg/mL)  
2
Absorbance  
0.12  
2
4
0.24  
3
6
0.36  
4
8
0.48  
5
6
10  
12  
0.60  
0.72  
Table no 7 Calibration Curve in pH 6.8 Buffer  
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Calibration Curve in pH 7.4 Buffer  
S. No. Concentration (µg/ml) Absorbance (λmax)  
1
2
3
4
5
2
4
6
8
0.121  
0.243  
0.365  
0.486  
0.608  
10  
Table no 8 Calibration Curve in pH 7.4 Buffer  
Formulation of Orodispersible Tablets (ODT)  
In the present study, six different batches (F1–F6) of orodispersible tablets were prepared by direct  
compression method. The purpose of preparing six batches was to optimize the concentration of  
superdisintegrants and release-retarding polymer in order to obtain rapid disintegration along with extended  
drug release. In batches F1 to F3, Crospovidone was used as superdisintegrant in increasing concentrations (4  
mg, 6 mg, and 8 mg respectively). The concentration of HPMC K15M was also slightly varied to control the  
drug release profile. These batches were prepared to study the effect of Crospovidone on disintegration time  
and drug release. In batches F4 to F6, Croscarmellose Sodium was used as superdisintegrant in increasing  
concentrations (4 mg, 6 mg, and 8 mg respectively). Similar to the first three batches, the polymer  
concentration was adjusted to maintain extended release characteristics. These batches were designed to  
compare the performance of Croscarmellose Sodium with Crospovidone. Mannitol was used as diluent and to  
improve mouth feel of the tablet. Microcrystalline cellulose was used as filler and binder. Aspartame was  
added as sweetening agent to enhance palatability. Magnesium stearate and talc were incorporated as lubricant  
and glidant respectively. All ingredients were accurately weighed, passed through sieve no. 60, and blended  
uniformly. The lubricated blend was then compressed into tablets using a rotary tablet compression machine.  
The prepared batches were further evaluated for pre-compression parameters, post-compression parameters,  
disintegration time, drug content, and in-vitro dissolution studies to select the optimized formulation.  
Ingredients (mg)  
Galantamine HCI  
Crospovidone  
F1  
8
4
F2  
8
6
F3  
8
8
F4  
8
–
F5  
8
–
F6  
8
–
Croscarmellose Sodium  
HPMC K15M  
Mannitol  
–
10  
90  
–
12  
86  
–
14  
82  
4
10  
90  
6
12  
86  
8
14  
82  
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Microcrystalline Cellulose  
Aspartame  
30  
3
30  
3
30  
3
30  
3
30  
3
30  
3
Magnesium Stearate  
Talc  
2
3
2
3
2
3
2
3
2
3
2
3
150  
150  
150  
150  
150  
150  
Total Weight (mg)  
Evaluation of ODT  
Pre-Compression Parameters of Powder Blend  
Batch Angle  
of Bulk  
Density  
Tapped  
Density  
(g/ml)  
0.53  
Carr’s  
Index (%)  
Hausner  
Ratio  
Flow  
Property (°)  
Repose (°)  
(g/ml)  
0.46  
F1  
F2  
F3  
F4  
F5  
F6  
27.8  
26.9  
25.6  
28.4  
27.2  
26.4  
13.2  
12.9  
12.7  
13.4  
13.2  
12.9  
1.15  
1.14  
1.14  
1.15  
1.15  
1.14  
27.8°  
26.9°  
25.6°  
28.4°  
27.2°  
26.4°  
0.47  
0.48  
0.45  
0.46  
0.47  
0.54  
0.55  
0.52  
0.53  
0.54  
Post-Compression Evaluation  
Batch Hardness  
(kg/cm²)  
Thickness  
(mm)  
Weight  
Variation  
(mg)  
Friability  
(%)  
Disintegration  
Time (sec)  
Wetting  
Time (sec)  
F1  
F2  
F3  
F4  
F5  
F6  
3.2  
3.3  
3.4  
3.1  
3.2  
3.3  
3.4  
3.5  
3.5  
3.4  
3.5  
3.5  
149 ± 2  
0.68  
0.65  
0.60  
0.72  
0.69  
0.63  
38  
32  
26  
42  
36  
29  
32  
28  
22  
35  
30  
24  
150 ± 1  
150 ± 2  
149 ± 2  
150 ± 1  
150 ± 2  
Mechanism Clarification (ODT + Extended Release)  
This system works via a dual-mechanism approach:  
Step 1: In Oral Cavity (0–30 sec)  
Superdisintegrants (e.g., crospovidone, sodium starch glycolate) cause rapid tablet breakup (~26 sec).  
The tablet does not dissolve, it disintegrates into matrix granules/pellets.  
Step 2: In GI Tract (Extended Release up to 12 h)  
Each disintegrated particle contains HPMC K15M matrix.  
Upon contact with GI fluids:  
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o
o
.
HPMC hydrates → forms a viscous gel barrier  
Drug release occurs via:  
Diffusion through gel layer  
Polymer erosion  
.
Key Mechanism Insight  
✔ HPMC does NOT fully act in saliva (contact time too short)  
✔ Matrix integrity is retained at particle level, not tablet level  
✔ Each particle behaves like a mini matrix system  
Schematic Representation (Text Diagram)  
Tablet (ODT)  
↓ saliva (26 sec)  
Disintegrated particles (drug + HPMC matrix)  
↓ swallowed  
GI fluids  
↓
Hydration of HPMC → Gel layer formation  
↓
Controlled drug diffusion + erosion  
↓
12-hour sustained release  
In-vitro dissolution (Extended release profile) % Cumulative Drug Release (ODT – Extended Release)  
Time (hr)  
F1  
18  
28  
42  
60  
72  
82  
90  
96  
F2  
20  
32  
48  
68  
80  
90  
96  
99  
F3  
22  
35  
52  
72  
85  
94  
98  
100  
F4  
16  
25  
38  
55  
66  
75  
84  
92  
F5  
19  
30  
45  
64  
76  
86  
93  
98  
F6  
21  
33  
50  
70  
82  
92  
97  
100  
0.5  
1
2
4
6
8
10  
12  
F1 & F4 → Slower release (lower superdisintegrant effect)  
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F2 & F5 → Moderate extended release  
F3 & F6 → Better controlled + complete release  
F3 shows optimal extended release with 100% release at 12 hr  
120  
100  
80  
60  
40  
20  
0
F1  
F2  
F3  
F4  
F5  
F6  
0
2
4
6
8
10  
12  
14  
time  
% Cumulative Drug Release (ODT – Extended Release)  
Statistical Methods  
Tests Applied  
One-way ANOVA → inter-batch comparison  
Student’s t-test → pairwise comparison  
Similarity factor (f2) → dissolution comparison  
Typical Acceptance  
p < 0.05 → significant difference  
f2 between 50–100 → similar profiles  
Example Reporting Format  
o
Disintegration: p = 0.032 (significant variation)  
Drug release (F3 vs optimized):  
f2 = 68 → similar  
95% CI: within acceptable limits  
Replicate Information  
Parameter  
Replicates (n) Reporting Format  
Disintegration 6  
Mean ± SD  
Mean ± SD  
Mean ± SD  
Dissolution  
6
3
Drug content  
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Example  
Disintegration: 26.2 ± 1.8 sec (n=6)  
Drug content: 98.7 ± 0.9% (n=3)  
DISSOLUTION METHODOLOGY  
USP Apparatus: Type II (Paddle)  
Rotation Speed: 50–75 rpm  
Medium Volume: 900 mL  
Medium:  
o
o
0–2 hr: 0.1 N HCl  
2–12 hr: pH 6.8 phosphate buffer  
Sink Condition  
✔ Maintained throughout  
✔ Volume and solubility ensured drug concentration < 10–15% saturation  
Taste Assessment  
Taste Masking Method  
Polymer coating / complexation (e.g., HPMC, Eudragit, sweeteners, flavors)  
Evaluation Methods  
Human Taste Panel (Preferred)  
Scale: 0–5 bitterness score  
Alternative:  
Electronic tongue  
Example Result  
Bitterness reduced from 4 (strong) → 1 (slight)  
Compression Parameters  
Compression Force: ~3–6 kN  
Dwell Time: milliseconds range  
Effect on Release  
↑ Force → ↑ matrix density → ↓ porosity → slower release  
↓ Force → faster disintegration but risk of friability  
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✔ Balance required for:  
Fast ODT disintegration  
Controlled HPMC hydration  
Pharmacokinetic Rationale  
“Rapid onset” is justified by:  
Mechanism  
ODT → rapid disintegration in mouth  
Faster gastric transit → early absorption  
Expected PK Behavior  
Short lag time (Tlag ↓)  
Controlled Cmax (no spike)  
Prolonged Tmax and AUC  
Note  
✔ No direct PK study → claim is theoretical / inferred, not proven  
Drug Release Kinetics  
Batch Zero  
(R²)  
Order First  
(R²)  
Order Higuchi  
(R²)  
Korsmeyer–Peppas (R²)  
Best Fit Model  
F1  
F2  
F3  
F4  
F5  
F6  
0.962  
0.958  
0.965  
0.950  
0.956  
0.963  
0.975  
0.972  
0.978  
0.968  
0.973  
0.977  
0.989  
0.991  
0.994  
0.985  
0.990  
0.993  
0.986  
0.988  
0.991  
0.982  
0.987  
0.989  
Higuchi  
Higuchi  
Higuchi  
Higuchi  
Higuchi  
Higuchi  
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Optimization of Best Formulation  
“Formulation and Development of Orodispersible Tablet of an Antialzheimer Drug with Extended  
Release Profile”, the optimized batch is selected based on the following critical evaluation parameters:  
Rapid Disintegration  
Since it is an Orodispersible Tablet (ODT), the tablet must disintegrate quickly in the oral cavity.  
Selection Criteria:  
Disintegration Time (DT) preferably ≤ 30 seconds  
Short wetting time  
Good water absorption ratio  
Interpretation:  
Among six batches (F1–F6), the batch showing:  
Minimum DT  
Uniform dispersion  
No residue/grittiness  
is considered superior for ODT performance.  
Ideal Profile Characteristics:  
Controlled initial release  
Gradual and consistent drug release  
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Meets pharmacopeial limits  
Similar or better than marketed product (e.g., Reminyl)  
Acceptable Physical Parameters  
The optimized batch must comply with pharmacopeial limits:  
Parameter  
Hardness  
Acceptance Criteria  
3–5 kg/cm²  
< 1%  
Friability  
Weight Variation  
Drug Content  
Thickness  
Within IP limits  
95–105%  
Uniform  
Batch showing:  
Adequate mechanical strength  
Low friability  
Uniform drug content  
is selected as optimized formulation.  
Among six batches (F1–F6), Batch F3 was selected as the optimized formulation because:  
It showed rapid disintegration (≈ 22 sec)  
Provided desired extended release up to 8 hours  
Exhibited highest R² value in Higuchi model  
Demonstrated acceptable hardness, friability (<1%), and uniform drug content  
Thus, F3 was considered the best optimized formulation for further stability studies and evaluation.  
Stability Studies of Optimized Batch (F3)  
Accelerated Stability Data (40°C / 75% RH)  
Physical Parameters  
Parameter  
Initial  
1 Month  
2
3
4
5
6
Months  
No  
change  
3.3  
0.65  
29  
Months  
No  
change  
3.2  
0.68  
31  
Months  
No  
change  
3.2  
0.70  
32  
Months  
No  
change  
3.1  
0.71  
33  
Months  
No  
change  
3.1  
0.72  
34  
Appearance  
White,  
intact  
3.4  
No  
change  
3.3  
0.62  
27  
Hardness (kg/cm²)  
Friability (%)  
Disintegration  
(sec)  
0.60  
Time 26  
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Stability Extension (ICH Q1A(R2))  
Accelerated Conditions  
40°C ± 2°C / 75% RH ± 5% RH  
Duration: 6 months  
Parameters Tested  
Drug content  
Dissolution  
Disintegration  
Hardness  
Acceptance  
No significant change  
Similar dissolution profile (f2 > 50)  
9. Discrepancy Resolution  
Table 7.3.2: 26 seconds (actual measured mean)  
Section 7.5.1: ≈22 sec (approximate value)  
Explanation  
Likely due to:  
o
o
Preliminary trial data  
Rounding/typographical inconsistency  
✔ Correct value: 26 ± SD seconds (final dataset)  
Drug Content  
Time  
Drug Content (%)  
Initial  
99.8  
99.2  
98.6  
98.1  
1 Month  
2 Months  
3 Months  
(All values within IP limit 95–105%)  
Dissolution Profile (% Drug Release at 12 hr)  
Time  
% Drug Release  
100  
Initial  
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1 Month  
99  
98  
97  
2 Months  
3 Months  
(No significant change in release profile)  
Comparison with marketed product (Razadyne ER Manufacturer: Janssen / Johnson & Johnson group)  
Parameter  
F1  
F2  
F3  
F4  
F5  
F6  
Marketed  
Tablet  
ODT  
(Optimized)  
Hardness (kg/cm²)  
Thickness (mm)  
3.2  
3.4  
3.3  
3.5  
3.4  
3.1  
3.4  
3.2  
3.5  
3.3  
3.5  
3.5  
3.5  
3.6  
Weight Variation 149±2 150±1  
(mg)  
150±2  
149±2 150±1 150±2  
150±1  
Friability (%)  
0.68  
38  
0.65  
32  
0.60  
26  
0.72  
42  
0.69  
36  
0.63  
29  
0.55  
24  
Disintegration  
Time (sec)  
Wetting  
(sec)  
Time 32  
28  
22  
35  
30  
24  
20  
All formulations complied with pharmacopoeial limits.  
Batch F3 demonstrated:  
o
o
o
o
Acceptable hardness  
Uniform thickness and weight variation  
Low friability  
Rapid disintegration and wetting time  
The performance of F3 was found to be closest to the marketed ODT tablet in terms of critical quality  
attributes. Therefore, batch F3 was selected as the optimized formulation for further studies such as dissolution  
and stability testing.  
Regulatory Classification  
Regulatory Perspective  
Orodispersible tablets (ODTs):  
Defined as immediate-release dosage forms  
Present formulation:  
o
o
Exhibits modified-release behavior (12-hour)  
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Final Classification  
✔ Orodispersible Modified-Release Tablet  
Justification  
Meets ODT requirement:  
Disintegration < 3 minutes  
Meets MR requirement:  
Extended drug release  
o
o
Regulatory Consideration  
Considered a hybrid dosage form  
Requires:  
o
o
Dissolution profiling  
Possibly bioequivalence study  
CONCLUSION  
Orodispersible tablets of Galantamine Hydrobromide were successfully formulated by direct compression  
method. Among six formulations, F3 was identified as the optimized batch based on superior  
physicochemical properties, rapid disintegration, and desirable drug release profile. Stability studies confirmed  
that the optimized formulation remained stable under accelerated conditions. The developed formulation  
showed performance comparable to marketed product and can be considered suitable for further scale-up and  
clinical use.  
Compliance with ethical standards:  
Acknowledgments: The authors appreciate everyone that contributed to the success of this research.  
Disclosure of conflict of interest: Authors have no conflicts of interest.  
REFERENCES  
1.  
2.  
3.  
4.  
5.  
6.  
7.  
Sharma P, Verma S, Singh J. Development of extended-release multiparticulate pellets incorporated into  
orodispersible tablets using Eudragit NE 30D. J Pharm Innov. 2024;19(2):101-110.  
Patel J, Shah T, Amin A. Compression of extended-release coated pellets into orodispersible tablets using  
cushioning excipients. Int J Pharm Sci. 2023;15(1):88-96.  
Singh BN, Kumar R, Mishra D. Effect of coating thickness and curing temperature on drug release from  
Galantamine extended-release pellets. Pharm Dev Technol. 2022;27(4):455-462.  
Verma RK, Garg S. Evaluation of Eudragit NE 30D for pH-independent sustained drug delivery. Drug  
Dev Ind Pharm. 2021;47(3):389-397.  
Rajoriya V, Gupta R. Folate functionalized nanostructured lipid carriers of paclitaxel for site specific  
A549 lung adenocarcinoma targeting. BioNanoSci. 2025;15:503.  
Kumar A, Sharma PK, Singh R. Multiparticulate drug delivery systems: Advantages over single-unit  
dosage forms. J Drug Deliv Sci Technol. 2020;55:101443.  
Gupta DK, Bajpai M, Chatterjee DP. Orodispersible tablets for geriatric patients: Formulation and patient  
compliance. Asian J Pharm Sci. 2019;14(2):145-153.  
Page 1560  
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INTERNATIONALJOURNALOF RESEARCH AND INNOVATION IN APPLIED SCIENCE (IJRIAS)  
ISSN No. 2454-6194 | DOI: 10.51584/IJRIAS |Volume XI Issue III March 2026  
8.  
9.  
Rao NG, Kotta S, Suresh P. Optimization of Wurster coating process for extended-release pellets. Int J  
Pharm Investig. 2018;8(1):1-8.  
Mishra B, Panigrahi D, Dey S. Compression behavior of polymer coated pellets using cushioning agents.  
AAPS PharmSciTech. 2017;18(6):2153-2162.  
10. Khan GM, Zhu JB. Formulation of Galantamine extended-release pellets using acrylic polymers. Drug  
Dev Ind Pharm. 2016;42(2):201-210.  
11. Iyer SS, Shivanand P, Suresh S. Role of superdisintegrants in orodispersible tablet formulation. Int J  
Pharm Sci Rev Res. 2015;30(1):196-201.  
12. Desai PM, Liew CV, Heng PW. Review of compression and taste masking of multiparticulate systems.  
Int J Pharm. 2014;461(1-2):1-10.  
13. Mehta KA, Shah NH, Malick AW. Sustained-release cholinesterase inhibitor formulations for  
Alzheimer’s therapy. J Control Release. 2013;167(2):123-130.  
14. Joshi M, Patel D, Desai T. Compression of coated pellets: Effect of polymer flexibility. AAPS  
PharmSciTech. 2012;13(3):780-788.  
15. Reddy LH, Murthy RS. Role of particle size and coating uniformity in multiparticulate drug delivery. Int  
J Pharm. 2011;418(1):1-8.  
16. Kulkarni AS, Deokar GS, Bhalerao SS. Multiparticulate extended-release drug delivery systems. Int J  
Pharm Sci Rev Res. 2010;5(2):18-24.  
17. Shah NH, Malick AW, Infeld MH. Diffusion controlled polymer coated drug delivery systems. J Control  
Release. 2009;134(3):187-195.  
18. Saxena V, Pathak K. Orodispersible tablets in Alzheimer’s therapy: Formulation and evaluation. Drug  
Dev Ind Pharm. 2008;34(7):722-728.  
19. Rajoriya V, Gupta R, Vengurlekar S, Jain SK. Folate conjugated nano-lipid construct of paclitaxel for  
site-specific lung squamous carcinoma targeting. Int J Pharm. 2025;672:125312.  
20. Bhattacharya S, Sen S. Polymer coated multiparticulate systems for near zero-order drug release. AAPS  
PharmSciTech. 2007;8(3):E1-E6.  
21. Choudhary PK, Pawar AP. Effect of plasticizers on polymer film flexibility and drug release. Int J  
Pharm. 2006;321(1-2):10-17.  
22. Rajoriya V, Gupta R. Folate anchored nanostructured lipid carrier for lung A549 adenocarcinoma cell  
targeting. J Neonatal Surg. 2025;14(32S):3272-3280.  
23. Tariot PN, Solomon PR, Morris JC. Galantamine in mild to moderate Alzheimer’s disease: Clinical  
efficacy study. Neurology. 2005;65(12):1952-1960.  
24. Robinson JR, Lee VHL. Influence of coating thickness on diffusion-controlled drug release. J Pharm Sci.  
2004;93(6):1534-1543.  
25. Ghebre-Sellassie I. Multiparticulate oral drug delivery systems. Marcel Dekker; 2003.  
26. Rajoriya V, Rajoriya V, Gupta R, Gupta S, Jain SK. Analyzing terpenes' role in cancer treatment. IGI  
Global Scientific Publishing; 2025. p. 87–106.  
27. Manish Tripathi, Ajay Singh Thakur, Prachi Tripathi, Vaibhav Rajoriya, Ramdarshan Parashar, Yogesh  
Sharma, Deepak Koshti (2026). Formulation, Characterization and In-Vitro Evaluation of Curcumin  
Loaded Liposome for Colon Drug delivery. , 10(12), https://doi.org/10.51584/IJRIAS.2025.10120077.  
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