Shri Chhatrapati Shahu Maharaj Shikshan Sanstha Institute of Pharmacy, Maregaon.
Oral route drug delivery system is still considered as the most convenient and patient friendly drug delivery route. Odf’s are an innovative dosage form that breaks down and dissolves within the oral cavity. Notably, fast-dissolving oral thin films offer a practical solution for a patients such as those in pediatric, as well as geriatric population who struggle with a tablet or hard gelatin capsule ingestion. These rapid- dissolving films are better than fast-disintegrating tablets since the latter have choking and friability issues. This drug delivery technology offers several benefits over traditional fast-disintegrating tablets, including the ability to be used for dysphasic and schizophrenic patients and the capacity to be taken without water due to their quick disintegration and rapid release of medicine in the mouth. This present review provides a brief summary of challenges, composition, formulation methods and evaluation parameters employed for oral disintegrating.
“These are drug delivery systems that they are quickly releasing the drug by dissolving or adhering in the mucosa with saliva within a few seconds due to it contains water-soluble polymers when it placed in the mouth cavity or on the tongue”. The oral route is the most preferred route by patients among the several routes of administration. Most pharmaceutical firms have focused their research efforts on finding feasible oral dosage form options for pediatric, geriatric, noncompliant, or nauseated patients [2]. There are 3 different subtypes of oral film, which are classified according to several factors including surface area, thickness, structure, excipients, and application area. These drug delivery systems can be applied topically, buccally, sublingually, orally, or by a combination of these routes. When placed on the tongue, these films exhibit the behaviour of either dissolving or disintegrating in salivary fluids without the need for water, making them an alternative to rapidly dissolving tablets. The improved systemic bioavailability is owing to the bypassing of the first pass effect and improved permeability as a result of well-supplied vascular and lymphatic drainage [6].
ADVANTAGES
1. Reducing the chance of choking
DISADVANTAGES
Oral Mucosa
Three layers of cells make up the verbal mucosa :
Figure No. 1 :- Structure of oral mucosa (Mahajan et al., 2013)
Concentration Of Components
Table No. 1 :- Concentration of components
|
Sr. No. |
Ingredients |
Concentration |
|
1. |
Drug |
1-30% |
|
2. |
Film-forming polymer |
40-50% |
|
3. |
Plasticizer |
0-20% |
|
4. |
Saliva stimulating agent |
2-6% |
|
5. |
Sweetening agent |
3-6% |
|
6. |
Flavouring agent |
Q. S |
|
7. |
Surfactant |
Q. S |
|
8. |
Colours, Filler |
Q. S |
Composition Of Oral Disintegrating Films
Drug
Typically constituting 1-30% w/w in a standard film, the medicate is significant for dynamic definition. The consolidation of micronized API is basic to upgrade the film’s surface and guarantee fast disintegration and consistent in the fast-disintegrating film. [5]. API to be joined into ODF in a perfect world ought to be low dosage, non-bitter and have highwater solubility (BSC class 1 such as paracetamol, propranolol and diltiazem).[6] Drugs counting salbutamol sulphate, rizatriptan benzoate, verapamil, ondansetron, dexamethasone, rofecoxib, cetirizine, pilocarpine, tianeptine sodium, indomethacin, etc. are as often as possible included in ODFs. Furthermore, an ODF containing a prochlorperazine an anti-emetic sedate was created utilizing microcrystalline cellulose and other film-forming polymer.[2]
Hydrophilic Polymers
Hydrophilic polymer is the fundamental operator in shaping the film. Hydrophilic polymer can break up in water effortlessly. The lower the atomic weight of the polymer, the quicker the disintegration rate [6].
Ideal properties of polymer -
Plasticizers
In common, including plasticizer to details moves forward mechanical properties counting pliable quality and percent stretching [2]. The cautious choice of appropriate plasticizers is basic to guarantee compatibility with the medicate, polymers, and other excipients, anticipating part, splitting, and peeling issues. [7]. A few of the most commonly utilized plasticizer incorporate glycerol, propylene glycol, PEG, dimethyl, castor oil, etc[2].
Sweetning Agent
To cover up the foul taste and smell of the active substance, a sweetening agent is required. There are two categories of sweetening agents: artificial and natural sources[6]. All natural sweeteners belong to the saccharide family; examples of natural sugars include sucrose, dextrose, fructose, glucose, liquid glucose, and isomaltose. Artificial sweeteners include cyclamate, aspartame, acesulfame K, sucralose, alitame, neotame, and saccharin.[2]
Saliva Stimulating Agent
Saliva incitement chemicals are utilized to boost spit generation, which makes a difference the details for quick crumbling strip items break down more rapidly. The substances that are most as often as possible used incorporate citric corrosive, lactic corrosive, maleic corrosive, ascorbic corrosive, tartaric corrosive etc[2] Examples of spit invigorating specialists are citric corrosive or ascorbic corrosive at 26% w/w utilized alone or in combination [6].
Flavouring Agent
Flavors play a significant role in masking the bitter and unpleasant taste of the API. Apart from taste and personal liking, the age of the target user can influence selection of flavors. Younger people prefer fruit punch, raspberry etc. whereas geriatric prefers orange, lemon and mint [6].
Electronic tongues are used to assess the effectiveness of various taste masking agents. According to a study, the bitter taste of diclofenac sodium may be effectively covered up by a blend of the flavours by mint, liquorice, and sucralose [2].
Surfactant
Surfactant is utilized to improve the solvency and wetting property of the film, permitting it to be discharged inside minutes or less than that [6]. Poloxamer 407, benzathanium chloride, sodium lauryl sulphate, tweens, benzalkonium chloride, and other common fixings are utilized. The most regularly utilized surfactant among them is poloxamer 40 [2].
Colouring Agent
As colouring agents, pigments are employed. ODFs and other medicinal preparations most frequently utilise titanium dioxide as a colorant. In addition to titanium dioxide, a broad spectrum of colours, such as FD and C, natural hues, and customised pantone matched hues, are offered [2].
Method Of Preparation
There are numerous strategies utilized to define ODF such as dissolvable casting strategy, semisolid casting, rolling strategy, strong scattering expulsion and splashing strategy. Diverse strategy has distinctive points of interest and drawbacks that can be considered some time recently doing the film [6]. We are study various types of methods such are following
Solvent casting strategy the least difficult however the most seasoned film-making strategy. The API is broken down in a reasonable dissolvable. Polymers, plasticizers and any other fixings can be broken in another parcel of dissolvable to plan a polymeric solution [6].
Figure No. 2 :- Solvent casting method (Ghodake et al., 2013)
ODF’S By Using Solvent Casting Method by An Some API
1. Captopril
Preparation Of ODF’S
ODFs were arranged utilizing full factorial DoE approach utilizing two components and three levels (32) utilizing the statistica form 13.1 computer program (TIBCO Statistica Inc., CA, USA), coming about in nine definitions. The movies were arranged by dissolvable casting strategy utilizing HPMC E6 (2%, 2.5%, and 3%) as a film- forming operator, and GLY, PP or PEG as plasticizers (10% mass polymer, w/w). EDTA was utilized as an antioxidant specialist . To get ready the definitions 25 mg of CPT was weighed, scattered in adequate sum of filtered water, and subjected to blending on a 10position attractive stirrer. At that point, the plasticizer (GLY,PP, OR PEG) and HPMC E6 (2%, 2.5%, or 3%) were included, and the volume was completed with filtered water (q.s. to 6ml). After 30 min, blending was halted, and the scatterings were kept at rest for 30 min for deaeration. The scatterings in this way gotten were exchanged to a polystyrene shape (120 x120mm,144 cm2 of range), and dried in an stove with constrained discuss circulation and reestablishment (40.0 ± 0.5°C) for 24 h. The movies were evacuated from the molds., wrapped in an aluminium thwart, and put in a desiccator. The sum of CPT in ODF’s was calculated concurring to Ali, such that each unit of ODF (6 cm2) contains 25 mg of CPT. Movies without plasticizer (F1-WP, F4-WP and F7-WP) were arranged for comparison [9].
Table No. 2 :- Composition Of Captopril [9]
|
Composition |
ODFs |
||||||||
|
F1 |
F2 |
F3 |
F4 |
F5 |
F6 |
F7 |
F8 |
F9 |
|
|
CPT (mg) |
600 |
600 |
600 |
600 |
600 |
600 |
600 |
600 |
600 |
|
HPMC E6 LV (%) |
2.0 |
2.0 |
2.0 |
2.5 |
2.5 |
2.5 |
3.0 |
3.0 |
3.0 |
|
EDTA Na (%) |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
0.1 |
|
1Plastificizer |
GLY |
PP |
PEG |
GLY |
PP |
PEG |
GLY |
PP |
PEG |
|
Water, q.s. (mL) |
45 |
45 |
45 |
45 |
45 |
45 |
45 |
45 |
45 |
1equivalent to 10% of the polymer mass
2. Aprepitant
Preparation of drug loaded fast dissolving films
Polymeric solution (Solution A) was prepared by dissolving desired amount of pullulan in sufficient quantity of distilled water (70%). Specific quantity of drug along with polyethylene glycol and other excipients were dissolved in remaining water (30%) with continuous stirring (Solution B). Solution B was slowly added in polymeric solution A with continuous stirring. Final solution obtained was kept aside for 30 mins for defoaming. After defoaming, solution was poured in petri plate and dried at 45 °C in hot air oven for 24 h . Film casted in petri plate was then carefully peeled off and cut into pieces of desired shape and size. Different optimized combinations of film containing pullulan with PEG 400 were prepared and evaluated for the disintegration time, wetting time, folding endurance and drug release[10].
Preparation of pullulan based fast dissolving film of aprepitant using experiment
Table No. 3: - Composition Of Aprepitant [10]
|
Ingredients |
BF1 |
BF2 |
BF3 |
BF4 |
BF5 |
BF6 |
|
Pullulan (mg) |
50 |
100 |
150 |
200 |
250 |
300 |
|
PEG 400 (mg) |
16 |
32 |
48 |
64 |
80 |
96 |
|
Citric acid (mg) |
15 |
15 |
15 |
15 |
15 |
15 |
|
Tween 80 (ml) |
0.06 |
0.06 |
0.06 |
0.06 |
0.06 |
0.06 |
|
Mannitol (mg) |
15 |
15 |
15 |
15 |
15 |
15 |
|
Water (ml) |
20 |
20 |
20 |
20 |
20 |
20 |
|
Ingredients |
BF1 |
BF2 |
BF3 |
BF4 |
BF5 |
BF6 |
|
Pullulan (mg) |
50 |
100 |
150 |
200 |
250 |
300 |
|
PEG 400 (mg) |
16 |
32 |
48 |
64 |
80 |
96 |
3. Zolmitriptan
Preparation of standard solution
10 mg of zolmitriptan was accurately weighed into 10 ml volumetric flask and dissolved in small quantity of phosphate buffer pH 6.8 finally the volume was made up to 10 ml with pH 6.8 bufferi1 ml of the above solution was pipette into another 10 ml volumetric flask and the volume was made up to 10 ml pH 6.8 phosphate buffers (100 µg/ml). From the above stock-2 solution 0.2, 0.4, 0.6, 0.8 and 1ml solution was pipette out into 5 different 10ml volumetric flask respectively and the volume was made up to 10 ml with phosphate buffer pH 6.8 (2 µg/ml,4 µg/ml, 6 µg/ml, 8 µg/ml, 10 µg/ml) [1].
Preparation of fast disintegrating films
Solvent casting evaporation was used to create fast-dissolving films of zolmitriptan. The film was carefully extracted from its original shape and trimmed to a size of 10 x 10 cm?2;.Medifilms are stored in airtight containers and are subjected to evaluation studies. Design Expert portable software was used to carry out the statistical analysis of the experimental work. These factors were used in the design and formulation of films. To derive the second-order polynomial equation, an i3factor, i2-level full factor design methodology was employed. Concentration of HPMC iE i5i(X1), iPGi(X2), iSSGi(X3), and integration time (Y1), in vitro drug release (Y2), and endurance time (Y3) are examples of independent variables [1].
Table No. 4 :- Formulation Table Of Zolmitriptan [1]
|
S. no |
Ingredients |
|
|
Formulation codes |
|
|
|
||
|
F1
|
F2
|
F3
|
F4
|
F5
|
F6
|
F7
|
F8
|
||
|
1 |
Zolmitriptan (mg) |
1 2 5 |
1 2 5 |
1 2 5 |
1 2 5 |
1 2 5 |
1 2 5 |
1 2 5 |
1 2 5 |
|
2 |
HPMC E 5 (%) |
4 |
4 |
6 |
6 |
6 |
4 |
6 |
4 |
|
3 |
Propylene glycol (ml) |
1 |
1 |
3 |
1 |
1 |
3 |
3 |
3 |
|
4 |
Sodium starch |
2 |
4 |
2 |
2 |
4 |
4 |
4 |
2 |
|
|
glycolate (%) |
|
|
|
|
|
|
|
|
|
5 |
Aspartate (mg) |
1 5 |
1 5 |
1 5 |
1 5 |
1 5 |
1 5 |
1 5 |
1 5 |
|
6 |
Water (ml) |
1 0 |
1 0 |
1 0 |
1 0 |
1 0 |
1 0 |
1 0 |
1 0 |
4. Ramosetron Hydrochloride
Preparation of film
Mouth dissolving film of Ramosetron Hydrochloride was arranged by the dissolvable casting strategy. The watery arrangement was arranged by dissolving the water-soluble polymer in water. The other fixings were broken up in Ethanol 95% arrangement. Both mixtures were mixed to form homogenous viscous solution. The entrapped air was removed by putting it into sonicator. The coming about arrangement was casted as a film on a petridish and was permitted to dry. Arranged movies were carefully evacuated from the petridish, checked for any blemishes and at that point cut into the 2×2 cm2, each containing 5 mg Ramosetron Hydrochloride. The movies were put away in air proof plastic holder till assist use[12].
Table No. 5 :- Composition Of Aspartame Film[12]
|
Ingredient |
F1 |
F2 |
F3 |
|
Ramosetron Hydrochloride (mg) |
73.075 |
73.075 |
73.075 |
|
HPMC E5 (mg) |
500 |
500 |
500 |
|
PEG 400 (%) |
15 |
15 |
15 |
|
Aspartame (mg) |
10 |
20 |
30 |
|
Menthol (mg) |
40 |
40 |
40 |
|
Ethanol (ml) |
7 |
7 |
7 |
|
Distilled Water (ml) |
5 |
5 |
5 |
Polymers with low atomic weight and moo consistency are utilized in hot soften expulsion. The HME prepare has been connected as often as possible in pharmaceutical industry. In spite of the fact that the handle is unacceptable for thermolabile API, the strategy offers bounty of points of interest such as diminished chance of discuss entanglement, great reasonableness for scale up, more uniform scattering of fine particles due to seriously blending and disturbance, as well as great control of working parameters. [6].
Figure No. 3 :- Hot soften expulsion strategy (Muhammed et al., 2023)
ODF’S By Using Hot Melt Extrusion By An Some API
1.Zolpidem Tartarate
1.1 Formulation Advancement
1.1.2. Placebo Formulations
Placebo definitions were arranged by utilizing dissolvable casting strategy. The film shaping polymers HPMCE5, GUAR GUM and SODIUM ALGINATE were precisely weighed and scattered in 10 ml of refined water each and at that point doused for 4 hours. To these polymer arrangements, Mannitol was included with nonstop mixing on a attractive stirrer. The coming about bubble free arrangement was poured on to a glass plate and was dried at 50oC in hot discuss broiler for 24 hr. The fake treatment movies shaped were carefully evacuated from glass plate and assessed for drying time, normal weight, thickness, ductile quality, collapsing continuance and in vitro deterioration time [14].
2.1 Drug Loaded Formulation
The composition for the sedate stacked movies is given. The method taken after was comparative to the fake treatment details. The Zolpidem Tartarate was included to the polymer arrangement and sonicated for 15 minutes till the sedate was totally broken up. The medicate stacked movies were assessed for normal weight, thickness, malleable quality, collapsing perseverance, in vitro deterioration time and in vitro disintegration studies [14].
Table No. 6 :- Composition Of Zolpidem Tartarate Films[14]
|
|
HPMC E5 |
Guar Gum |
|||||
|
Ingredients |
F1 |
F2 |
F3 |
F4 |
F5 |
F6 |
F7 |
|
Drug (mg) |
62.5 |
62.5 |
62.5 |
62.5 |
62.5 |
62.5 |
62.5 |
|
Polymer (mg) |
125 |
187.5 |
250 |
62.5 |
125 |
187.5 |
250 |
|
Glycerol (mg) |
18.7 |
28.1 |
37.5 |
9.38 |
18.7 |
28.1 |
37.5 |
|
Mannitol (mg) |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
|
Flavour |
5% |
5% |
5% |
5% |
5% |
5% |
5% |
|
Distilled Water(ml) |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
This method employments undefined hydrophilic polymers to help the scattering of one or more drugs in a strong shape inside an dormant carrier to make a arrangement, and the medication is to begin with broken down in a appropriate dissolvable [16]. At that point, without expelling the fluid dissolvable, this arrangement is included to the liquefy of an fitting polymer, such as polyethylene glycol, that has come to a temperature beneath 70 oC. At long last, the strong scatterings are shaped into movies utilizing kicks the bucket [17].
ODF’S By Using Solid Dispersion Method By An Some API
1.Telmisartan
Formulation of oral fast dissolving films
The fast-dissolving films were prepared by solvent casting technique. Hypromellose was used as a film-forming hydrocolloid. Accurately weighed quantity of hydrocolloid was dissolved in a specified quantity of water. A weighted quantity of propylene glycol as a plasticizer was added to the above solution and dissolved by using a magnetic stirrer. Weighed quantity of Telmisartan SD was dissolved in 2 ml of appropriate solvent, separately. Solution of Telmisartan Solid Dispersion was added to a previously prepared solution of hydrocolloid and plasticizer and mixed thoroughly. The above solution is kept aside for 10 minutes for removal of air bubbles or may keep for sonication if required. Then cast on Petri plate and dried overnight to form the film. Then the film was carefully removed and cut into suitable size i.e. 2cm x 2cm. The above solution is kept aside for 10 minutes for removal of air bubbles or may keep for sonication if required. Then cast on Petri plate and dried overnight to form the film. Then the film was carefully removed and cut into suitable size i.e. 2cm[18].
Table No. 7:- Formulation Table Of Telmisartan[18]
|
Formulation Ingredients |
Formulation Code |
F1 |
F2 |
F3 |
F4 |
F5 |
F6 |
F7 |
F8 |
F9 |
|
Telmisartan (mg) |
664 |
|
664 |
664 |
664 |
664 |
664 |
664 |
664 |
664 |
|
HPMC (mg) |
600 |
|
650 |
700 |
600 |
650 |
700 |
600 |
650 |
700 |
|
SSG (mg) |
8 |
|
8 |
8 |
12 |
12 |
12 |
16 |
16 |
16 |
|
PG (ml) |
0.6 |
|
0.6 |
0.6 |
0.6 |
0.6 |
0.6 |
0.6 |
0.6 |
0.6 |
|
Citric Acid (mg) |
10 |
|
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
|
Mannitol (mg) |
20 |
|
20 |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
|
Water upto |
30 |
|
30 |
30 |
30 |
30 |
30 |
30 |
30 |
30 |
This technique involves creating a pre-mix, adding an active ingredient, and then forming a film. The solvent is primarily water or a water-alcohol mixture. The metering roller determined thickness of film. The film is cured on the rollers before being cut into the desired shapes and sizes[2].
Figure No. 4 :– Rolling Method ( H Devaraj et. al 2018)
ODF’s By Using Rolling Method By An Some API
1.Diphenhydramine HCL 5,7
Preparation of film
The preparation of the polymeric solutions involved dissolving employing a magnetic stirrer to mix the polymer in the solvent until a clear solution was achieved. The plasticizer (20% w/w of dry weight of polymer) was added to the resulting clear polymeric solution and swirled. The drug (20% w/v) was added to the resulting clear solution and dissolved while being constantly stirred to produce a transparent drug solution in a polymeric solution. Based on the drugs penetration an appropriate permeation enhancer was chosen and applied. roughly twelve distinct formulation where created utilizing four distinct polymer and three levels of polymer concentration variation[21].
Table No . 8:- Formilation Of Diphenhydramine Hcl Orally Fast -Dissolving Film In Mg [21]
|
11
|
F1 |
F2 |
F3 |
F4 |
F5 |
F6 |
F7 |
F8 |
F9 |
F10 |
F11 |
F12 |
|
Diphenhydramine HCL |
25 |
25 |
25 |
25 |
25 |
25 |
25 |
25 |
25 |
25 |
25 |
25 |
|
CMC |
166.67 |
83.20 |
124.95 |
|
104.16 |
|
|
|
124.95 |
|
|
104.16 |
|
Acacia |
|
|
124.95 |
|
104.16 |
166.67 |
83.20 |
|
124.95 |
104.16 |
|
|
|
PEG400 |
83.20 |
166.67 |
|
124.95 |
|
143.83 |
|
|
|
124.95 |
|
143.83 |
|
Glycerol |
|
|
124.95 |
|
145.83 |
|
83.20 |
166.67 |
124.95 |
|
145.83 |
|
|
Saccharin |
4.17 |
4.17 |
4.17 |
4.17 |
4.17 |
4.17 |
4.17 |
4.17 |
4.17 |
4.17 |
4.17 |
4.17 |
|
Citric Acid |
25.05 |
25.05 |
25.05 |
|
25.05 |
|
|
|
|
25.05 |
|
25.05 |
|
Mallic Acid |
|
|
|
25.05 |
|
25.05 |
25.05 |
25.05 |
25.05 |
|
25.05 |
|
|
SLS |
74.97 |
74.97 |
74.97 |
74.97 |
74.97 |
74.97 |
74.97 |
74.97 |
74.97 |
74.97 |
74.97 |
74.97 |
Comparative study of various drugs and its methods :-
Table No:- 09 [9,14,18,10,1,12]
|
Sr. No. |
Drug |
Method |
Material |
Challenges |
Evaluation |
|
1. |
Captopril |
Solvent Casting Method |
Api- Captopril Excipient- film forming polymer, Plasticizer, solubilizer, sweetners, Flavouring agent |
Moisture Control, Uniformity, |
Hplc, Dissolution, Sterility |
|
2. |
Zolpidem tartarate |
Hot melt extrusion |
Api- Zolpidem tartarate, Excipient – Plasticizer, sweeteners |
Stability studies, clinical trial for safety and efficacy |
Hplc, Dissolution test, Uniformity at dosage unit |
|
3. |
Telmisartan |
Solid dispersion method (kneading method) |
Api- Telmisartan Excipient- Plasticizer, Solubilizer, sweetners, flavouring agent. Odf composition- Telmisartan, HPMC, Glycerin |
Bioequivalence, Moisture Control |
HPLC, Heavymetal |
|
4. |
Aprepitant |
Solvent casting method |
Api- Aprepitant, Film forming polymer |
Taste masking, Stability, Moisture control |
Assay HPLC, Residual solvent GC, Disintegration time |
|
5. |
Zolmitriptan |
Solvent casting method |
Api- Zolmitriptan. HPMC,PVA, PVP Excipient- solvent, favouring agent, colourant |
Taste masking, stability, Flavour, Color uniformity |
Hplc, In vitro dissolution |
|
6. |
Donepezil |
Solvent casting method |
Api - Donepezil |
Formulation stability, Taste masking, Manufacturing stability |
Thickness, Moisture control, Stability |
|
7. |
Ramosetron hcl. |
Solvent casting method |
Api- Ramosetron hcl Film forming polymer, Hpmc Pdf composition- Glycerin, Polysorbate, HPMC |
Taste masking, Disintegration time, Stability |
Thickness, Moisture, Stability
|
|
8. |
Ondansetron |
Hot melt extrusion |
Api- ondansetron. Plasticizer, sweetners Odf composition- HPMC, Glycerin, Polysorbate |
Uniform drug distribution, Film thickness and strength, Moisture sensitivity, Stability and shelf life. |
HPLC, Heavy metal, Uniformity dosage unit. |
|
9. |
Benzocaine Menthol |
Solvent Evaporation |
HPMC, PVA |
Stability, Volatility, Taste masking |
Thickness, Disintegration testing, Uniformity |
|
10. |
Olanzapine |
Hot melt extrusion |
Api- Olanzapine.HPMC, Favouring agemnt. Odf composition- Olanazapine, HPMC, Glycerin, Polysorbate |
Stability, Taste masking, Disintegration time, Bioavailability |
Physical appearance, Drug uniformity, In-vitro release study |
|
11. |
Simethicone ODF |
Hot melt extrusion |
Film-forming polymers (HPMC,PVA,PVP) Plasticizer(Glycerin, glycol), Solvents(water, ethanol), Flavoring agents(mint,orange). |
Stability of Simethicone, Film integrity, Taste masking |
Disintegration time, Thickness uniformity, Moisture content |
Challenges In Formulating ODF
There is tremendous sum of writing accessible now days on detailing, improvement and assessment of verbal dissolving movies. The challenges that related to noncompliance towards pharmaceutical require to be given need to hand[6].
1.Taste Masking of Bitter Drugs
In the generation of quick-dissolving verbal movies, it is essential to cover the taste of severe drugs in arrange to increment persistent compliance, particularly among the elderly populace [6].
2. Long duration of drying
The drying time is a significant calculate in the detailing of verbal movies, as it influences the rate of generation in mechanical settings. In common, a hot discuss broiler cannot be utilized to dry verbal movies that contain thermo-labile drugs; hence, they are dried at room temperature instep, which would take indeed longer time to adequately dry [6].
3. Stability Against Temperature and humidity during handling and Storage
Obtaining film soundness against stickiness is challenging as film tend to retain water from muggy discuss and get melted. By the by, if the polymer utilized is exceedingly hygroscopic, it can frame hydrogen bond with water particles. In the nearness of stickiness, if the drug-polymer bond is weaker than polymer-water bond, undefined medicate nay experience stage division and crystallize[6].
4. Dose Uniformity
Insoluble materials debase undefined medicate to shape gems, consequently decreases disintegration rate of films. A few known strategies to guarantee dosage consistency incorporate :
1. Maintain a strategic distance from defining arrangement with tall consistency. For case, joining of polymers that frame exceedingly gooey arrangement may cause uneven conveyance and materials may knot together at one portion of the holder.
2. Utilize holders with level surface. Unpleasant surface decreases medicate and thickness
consistency, as arrangement may stay more on one side of the holder.
3. Utilize drying temperature that are underneath of dissolving point of drugs and excipients. Tall temperature amid drying may corrupt the chemicals in the movies.
4. Conduct test investigation based on determinations decided in pharmacopeia to assess the API substance in person film. For the most part, constrain of substance consistency should be between 85 to 115%.
Evaluation of Oral Disintegrating Films
Organoleptic properties
For this, practice
•Thickness test- d, directed human taste boards are utilized. This in vivo taste evaluation is performed on human members. Utilizing taste sensors for screening, in-vitro taste assessment of ODFs is carried out. High-throughput taste detecting of such dosage details can be fulfilled utilizing in vitro innovation and methods. Examination of the sweetness level and taste-masking properties of substances is done utilizing both in vivo and in vitro methods[2].
Mechanical properties-
•Dryness test- The reason of this test is to decide a film’s capacity to adhere to a piece of paper pushed between strips. Tack portrays the will fulness with which a piece of paper or any other adornment is constrained in between two movies. Various stages are recognized, such as dust-free, set-to-touch, tack-free, dry-hard, dry-to-touch, dry through (dry-to-handle), dry to-recoat, and dry print- free. Various apparatuses are available for conducting this test [13].
Tensile Strength
Tensile quality shows mechanical quality of the verbal movies. It shows greatest stretch required to break the strip when connected at a point. It was decided utilizing Surface Analyzer Steady Miniaturized scale framework. It can be decided by isolating the connected stack at burst by the strip’s cross-sectional region, as appeared in the condition below.[6]
Tensile quality = (stack at disappointment / strip thickness ×strip width) ×10.6
•Thickness test- Thickness test is conducted by measuring film at few diverse areas for occurrence 1 central point and 4 corners measured utilizing a calibrated advanced vernier caliper.. It is vital to affirm thickness consistency since it straightforwardly relates with the film’s dose accuracy.[2]
•Percent elongation-
When a film is pushed, the example extends, which is alluded to as strain. The definition of strain is the alter in film length separated by the film specimen’s introductory length. The rate of stretching is quantitatively relative to the plasticizer substance of the film detailing. In common, expanded plasticizer substance in the film advances strip stretching. It can be decided by equation given below. [2]
Percentage elongation = (alter in length / introductory length) ×100. [2]
Packaging of oral disintegration film
Packing considerations are basic for capacity, assurance and soundness of measurement shape. Bundling for verbal lean films incorporates thwart paper or plastic pockets, single pocket, aluminium pocket, rankle bundling with numerous units and Obstruction films are most commonly utilized for those drugs which are greatly dampness delicate.[19] A assortment of choices in bundling are accessible for quick crumbling verbal films. Single bundling is mandatory for films which are pharmaceutical items; an aluminium pocket is the most commonly utilized bundling framework. APR- Labtech has created the fast card, a exclusive and protected imaginative bundling framework which is particularly outlined for quick films. The fast card is precisely the same estimate as a credit card and holds three quick films on each side. Each dosage can be taken out independently, permitting the quiet to carry six single, bundled dosages of his medicine in his satchel or wallet and have it promptly accessible [20].
CONCLUSION
The main aim of the present study was to develop oral fast disintegrating film. Industries are considering the manufacture of commercially available products based on the increasing popularity of Odf formulations. The convenience and patient-friendly attributes of this dosage form make it a strong contender for widespread use in the market in the future[6]. The future of oral disintegrating films is characterized by advancements in formulation technology, expanding applications, and the incorporation of new technologies. Traditional dose forms are surpassed by these in terms of acceptability, patient compliance, and safety, with no risk of choking and greater efficacy. The fundamental purpose of ODF’s is to help paediatric, geriatric, and psychiatric patients who have trouble swallowing conventional dose forms. ODFs are now widely accessible for hypertension, acidity, allergy, and pain, indicating their significance [2].
REFERENCES
Gopal Khillari*, Anushka Ghubde, Ashutosh Khadatkar, Dr. Nilesh Chachda, Oral Disintegrating Film: Comparative Review of Formulation Strategies and Production Challenges, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 12, 1810-1824. https://doi.org/10.5281/zenodo.14444216
10.5281/zenodo.14444216
