**3.6 Researches on biopolymer**

Umashanker et al, NVS et al have isolated biopolymer from testa of Lallamantia royalena (Labiatae) and ready mucoadhesive biomaterial. Biopolymer was isolated by non-solvent technique. Mucoadhesivity of the biomaterial was decided by Park and Robinson and the rotating method. Spectrophotometric methods like UV, IR, TLC were conducted. The biomucoahesivity of the isolated biopolymer was confirmed by the IR method. In vitro and ex vivo evaluation was also conducted. Kala Shivani, NVS et al have formulated and evaluated bio micro dwarfs of nimesulide by isolating biomaterial from the rhizomes of (Zingiber Officinalis) common ginger. A simplified method was used for the isolation of biopolymer. IR characterization was administered for confirming the retardant activity of the biopolymer. In vitro studies, entrapment efficiency, and particle size analysis was also conducted. Tangri, Madhav [17] have isolated biomucoresident from the fruit pulp of *Artocarpus heterophyllus* commonly known as jackfruit (Moraceae), and formulated zidovudine loaded bio micro dwarfs. Particle size analysis, content uniformity, and IN-VITRO studies were conducted.IR spectrophotometry was also performed which confirmed the muco resident activity of the biomaterial. Muco retentive study was performed in the Novel Madhav Shankar study apparatus. Bisht, Upadhyay [18] have prepared polyherbal formulation for the treatment of dyslipidemia. Various sources from which polyherbal formulation was prepared are Picorrhiza kurroa, Emblica Officinalis, *Syzygium cumini*, *Trachyspermum Ammi*, Musa paradisiacal, Terminalia arjuna, pistachio, common ginger, onion, burn plant,

#### *Biopolymer: A Novel Bioexcipient DOI: http://dx.doi.org/10.5772/intechopen.97191*

*Eugenia caryophyllus*, cereal oat. Various tests that were conducted for the evaluation of the formulation are organoleptic, Physico-chemical investigation, viscosity, surface tension, and crude fat content.

Ojha, Madhav [10] have isolated biomaterial from the fruit pulp of *Phoenix dactylifera* commonly called date palm, and evaluated its mucoadhesivity.IR spectrophotometric was performed for confirmation of the mucoadhesive nature of the biopolymer. Other tests like acute toxicity studies were performed for 14 days on rats. The shear stress method and rotating cylinder method was used for evaluating the mucoadhesive nature of the biopolymer.

Yadav, Madhv, [19] have formulated rosiglitazone bio strips for targeting trans labial drug delivery [4]. Authors have isolated biomaterial from the pulp of jackfruit (Moraceae) by the simplified economical process. Folding endurance, Thickness, content uniformity tests were conducted for evaluated various parameters of the prepared formulation. *In-vitro* drug release and stability study was conducted of the bio lip strips. Bansal Abhishek, NVS, Sharma [20] have isolated biopolymer having bio emulgent activity from the fruit pulp of Prunus institica and formulated o/w sort of emulsion. The prepared emulsion was compared with a simple emulsion having acacia as an emulsifier. Various other evaluation tests conducted are FTIR, DSC, HPLC, INVITRO drug release study. Varshney Sugandha [21] isolated biopolymer from the fruit pulp of *Manilkara zapota* and ready bio flexy films having nanosized tiagabine as a model drug. The biopolymer which was isolated from the fruit pulp of *Manilkara zapota* was used on the soft palatal surface due to its biodegradable, biocompatible, and non-irritant in nature. Spectrophotometric tests that were conducted are UV, SEM, IR, colorimetry. For the evaluation of prepared bio flex films following tests were conducted folding endurance, thickness, INVITRO drug release study.

Varshney [21] isolated a unique biopolymer from the pulp of Solano melongena and formulated bio flexy films using nanosized tiagabine as a model drug.. The biopolymer which was isolated from the fruit pulp of eggplant was used on the soft palatal surface due to its biodegradable, bio-compatible and non-irritant. Particle size analysis was through with zeta potential. Other spectrophotometric tests that were processed are UV, IR, SEM, NMR. For the prepared bio flexy films following tests were conducted folding endurance, thickness, INVITRO drug release study, weight uniformity test. Varshney [22] isolated unique biopolymer from the pulp of Ananas Cosmoses and formulated bio flexy films loaded with nanosized tiagabine as a model drug. The prepared bio flexy films were used for targeting taste bud drug delivery and therefore the biopolymer incorporated in formulation had biodegradable, biocompatible nature. Solvent casting technique was used for preparation for bio flexy films. Spectrophotometric tests that were conducted are FTIR, NMR, UV, IR, colorimetry. Other tests were conducted are muco retention time, folding endurance, weight uniformity test, thickness, swelling percentage study.

Varshney [23] isolated a unique biopolymer from the seed of pepper and ready bio flexy films to tend through taste bud drug delivery. In the prepared bio flexy films the isolated biopolymer was used as film former and therefore the bio flexy films were used for the treatment of epilepsy. Spectrophotometric tests conducted were FTIR, UV, NMR, DSC, Colorimetry. For the evaluation of prepared bio flexy films muco retention, mucoadhesion, folding endurance, thickness, content uniformity, IN VITRO drug release study.

Sugandha [24] had isolated a unique biopolymer from the petals of Rosa Polyantha and used the biopolymer to organize bio-flexy films for taste bud drug delivery. Within the bio, flexy films nano- sized Tiagabine was used as the model drug. The isolated biopolymer had inbuilt filmability, biodegradable nature, biocompatible, mucoadhesive nature, so it is often used soft palatal surface.

Tests like DSC, UV, ZETA SIZING, Colorimetry was performed. The shear stress method was used for evaluating the muco adhesivity of the biopolymer. Prepared bio flexy films were evaluated for tests like thickness, folding endurance, content uniformity, mucoadhesion, EX VIVO retention study, cell line toxicity studies. Raina and Madhav [25]. Isolated biopolymer from the berries of pepper and ready bionanosuspension using escitalopram as a drug for brain targeting through the ear. Biopolymer isolated from pepper was used as a bio retardant within the bionanosuspension. Formulations were subjected to varied tests like pH, content uniformity, release study, and EXVIVO study. Raina Deepika et al. [26, 27] had isolated biopolymer from the kernels of almond and used the isolated biopolymer for preparing bionanogel loaded with chlorpromazine for brain targeting via the nose. Prepared nanoparticles were evaluated for drug content uniformity, entrapment efficiency, IN –VITRO, muco -adhesivity, SEM, and IR. Mala et al [28] isolated biopolymer from *Cucumis sativus* (cucumber) and used the isolated bioexcipient with cefuroxime to organize bionanogel for the treatment of encephalitis [29]. The isolated biopolymer was characterized by drug-polymer interaction study, Physicochemical characterization, and acute toxicity study. The prepared bio nanoparticles were subjected to various evaluation tests like pH study, Viscosity, entrapment efficiency, IN VITRO release, in vivo release, and stability study. Kirti Singh et al [30] performed the isolation of biopolymer from the roots of *Rosa centifolia* and vinifera and prepared terbinafine loaded bioadhesive layers for the treatment of nail disease onychomycosis. Within the formulation, Beta Vulgaricus was used as a bio penetrant. The formulated films were evaluated for various parameters like nail adhesivity, folding endurance, thickness, content uniformity, and IN VITRO drug permeation and stability studies. Kirti Singh et al [31] prepared bio flexy films containing atorvastatin as model drug and biopolymer isolated from Tapioca Sago. For the evaluation of biopolymer following tests were conducted UV, IR. The prepared bio flexy films were evaluated for parameters like weight, thickness, content uniformity, folding endurance, IN VITRO drug permeation, and surface Ph. Yogita Tyagi, et al [15] performed a search work on the preparation of aripiprazole loaded bionanogel containing bio retardant isolated from the bark of *Cinnamomum verum*. Prepared bio-nano gels were targeted for the brain targeting through layers of skin meninges, transcranial nerves. For the evaluation of prepared bionanogel following tests were administered ph measurement, IN VITRO drug release, and texture, spreadability, and a couple of entrapment efficacy and stability studies. NVS, Yogita Tyagi et al [32] developed bionanogel containing nanosized aripiprazole for brain targeting. The biopolymer used as a bioretardant and bio stabilizer within the nanogel was isolated from Pudina (*Mentha arvensis*). Isolated biopolymer was evaluated spectrophotometrically by IR and UV. Following tests were performed ph measurement, surface pH study, texture, spreadability, % entrapment efficacy, and IN VITRO drug release. Singh Bhavana et al [33] conducted a search study for the preparation of bio flex films containing Venlafaxine drug for the treatment of depression. For the preparation of bio Flexi films, biopolymer was isolated from the fruits of Luffa acutangula(angled loofah). Various physicochemical tests were conducted for the evaluation of biopolymers like color, solubility, and chemical tests. Different batches of bio flexy films were evaluated for IN VITRO and in vivo drug release, folding endurance, thickness. Bioflexy films were successful in sustaining the drug release so it is often concluded that biopolymer isolated from angled loofah has promising inbuilt mucoadhesive nature. Tyagi and Madhav [34] developed bionanosuspension having biopolymer which is isolated from seeds of Buchanania lanzan (Chironzi). In the bionanosuspension, the isolated biopolymer was used as a bioemulgent. Prepared bionanosuspension was used for the treatment of depression and its safety and compatibility were proved through various evaluation

#### *Biopolymer: A Novel Bioexcipient DOI: http://dx.doi.org/10.5772/intechopen.97191*

tests. For the characterization of biopolymer various spectrophotometric tests like DSC, UV, IR, SEM, and NMR were used. Bionanosuspensions was evaluated with the assistance of Particle size distribution studies, IN VITRO release, pH stability studies. Tyagi and Madhav [13] developed bio nanosuspension of fluvoxamine for the management of depression. The bio nanosuspension was incorporated with the novel biopolymer *Santalum album* (sandalwood tree) and it had been designed for ophthalmic delivery of the drug. Isolated biopolymer from solvent evaporation method was subjected to varied spectrophotometric tests like IR, DSC, SEM; AND NMR. Prepared bionanosuspension was evaluated for various evaluation tests like particle size, zeta potential, entrapment efficacy, IN VITRO drug release, stability studies. Ophthalmic delivery of fluvoxamine was proved to be the novelistic approach for the treatment of depression.

Madhav [35] stated that a novel biopolymeric the material can be used to prepare drug-loaded biomicrodwarfs from Arachis hypogea seeds. The goal was to produce a product with a significant processing advantage that satisfies pharmaceutical formulators in scale-up processes. The biopolymer was isolated and characterized for its capability and efficacy to control the release of the drug. Gupta et al. [36] have reported a method for isolation of a novel biodispersant from the seeds of *Cicero arietinum* and formulation of Escitalopram granules containing bio-dispersant. Bio-dispersant was isolated by the treatment of the extract from seeds of *Cicer arietinum* with double distilled water and with ethanol and the bio-dispersant was collected and further analyzed for physicochemical properties like color, odor, particle size, shape, solubility, and IR spectral studies. The preparation of Escitalopram, granules were done using drug, lactose, biodispersant, bio-binder, and other processing agents. We have prepared six different formulations with varying bio-dispersant concentration and bio-binder concentrations. Tangri et al., [37] detailed a method for the formulation and evaluation of sustained-release tablets of atorvastatin by utilizing the biomaterial as a novel binder for the formulation of tablets. For the isolation of biomaterial unripe fruit pulp of *Artocarpus heterophyllus* was taken and the process of isolation used was simplified economic process. The extracted biomaterial was subjected for various physical and chemical parameters like color, color changing point, chemical tests, and I.R. spectral study. Various formulation additives were used to prepare Ibuprofen sustained-release tablets. The three atorvastatin-loaded formulations (FA1-FA3) were prepared by using different drug-polymer ratios of 1:1, 1:3, 1:5, and other excipients like starch, talc, and lactose as diluents. Erasmus et al. [38] reported that cereal grains can also be used as an agricultural raw material rich in several biopolymers. Cereal grains contain major biopolymers like starch, protein, non-starch polysaccharides, and lipids. Dry milling, wet milling, or a combination of both can be used for the primary extraction of the biopolymers. The grain is separated into its anatomical components by conventional dry milling. Anatomical components can be enriched in certain biopolymers like endosperm flour consist of approximately 80% starch. Madhav et al. [39] described the novel biomaterial from the unripe fruit pulp of *Artocarpus heterophyllus* and the evaluation of its bio-emulsifying ability by the formulation of escitalopram loaded emulsions. The isolation of biomaterial was done from the unripe fruit pulp of *Artocarpus heterophyllus* by the simple and economic process. It was subjected to various Physicochemical parameters like color, color changing point, different chemical tests, and I.R. spectral study. Four drug-loaded emulsions were formulated (AH1-AH4) by using varying ratios of the biomaterial. Escitalopram was used as a model drug for the formulation of emulsions. Evaluation parameters like globule size, pH, the effect of centrifugation, viscosity, surface tension, creaming, freezing and thawing cycles, and *in-vitro* release were conducted on the formulated emulsions. The

presence of saturated hydrocarbons, aromatic ring secondary, and tertiary alcohol groups was reported in the IR spectra of the isolated biomaterial. Singh [40] described the various components involved in pharmaceutical formulation development apart from active pharmaceutical ingredients. In recent years, the core area of research in pharmaceutical drug delivery is the excipient development because of its effect on the formulation designing development and targeted drug delivery process in various ways. Because of their low toxicity, biodegradability, stability and renewable nature biopolymers have become the choice of research as excipients. In this review, some of the most commonly used biopolymers as excipients in pharmaceutical drug delivery systems designing have been discussed. Velde et al. [41] described that to know the most suitable matrix polymer, before starting the designing it is very important to know the properties of the available polymers. It was reviewed to give information on the most suitable property of a range of biodegradable polymers. Since the data are widely scattered over many sources and are very scarce compared to the conventional polymer. Data were presented mostly as ranges as well as in graphs for quick comparison reasons. One specific application, thermoplastic pultrusion with flax as reinforcement has been also studied. Singh et al. [42] isolated the biopolymer from Tapioca sago. After isolation, it was characterized for different parameters like viscosity, ph, conductivity, and other physical characteristics. The biopolymer was also tested for the presence of carbohydrates and proteins. The isolated biopolymer was also analyzed for different spectral analysis like FTIR. The isolated biopolymer was used for the preparation of bio gel loaded with curcumin for the dermal delivery. It was concluded that the curcumin-loaded bio gel can be effectively used for the treatment of the wound by using a novel isolated biopolymer from sago as a novel retardant cum stabilizer.

### **3.7 Bionanoformulation in drug targeting**

Madhav et al. [6] developed and evaluated duloxetine loaded bionanosuspension. The bionanosuspension was prepared by using the biopolymer isolated from *Prunus amygdalus* seeds. The biopolymer was characterized for different Physico-chemical characterization and different spectral characterization. The biopolymer was isolated by the simple economical extraction process and treatment with propanone and then solicited. The residue was recovered and dried to get the free-flowing powder. The duloxetine loaded bionanosuspension was prepared by the bath sonication method. The prepared bionanosuspension was then evaluated for different parameters like particle size, entrapment efficacy, dispersibility, zeta potential, in-vitro release, and in-vitro kinetic study, and also in-vivo study for the determination of the amount of duloxetine reached to brain via external acoustic meatus.

Madhav et al. [6] explored the feasibility of external acoustic meatus for targeting escitalopram bionanosuspension to the brain. The research reveals that escitalopram loaded bionanoparticles were found to be targeted to the brain via external acoustic meatus administration. The bionanosuspension was prepared by using the biopolymer from *Piper nigrum* in a different ratio. The biopolymer consists of the novel retardant properties to release the drug in a sustained manner. The research reveals that *Piper nigrum* can be safely used for the development of bionanosuspension for targeting the brain via external acoustic meatus. Raina et al. [6, 14, 25, 39, 43] described the preparation of duloxetine loaded bionanogel for brain targeting via external acoustic meatus. In the research work, the biopolymer was isolated from Tagetes papule and its ability in developing the duloxetine loaded bionanogel for brain targeting. In the findings of the research, the biopolymer was found to have a novelistic characteristic as polymeric nature in developing the

### *Biopolymer: A Novel Bioexcipient DOI: http://dx.doi.org/10.5772/intechopen.97191*

bionanosuspension. The bionanosuspension was found to be suitable for delivering the drug to the brain. So the conclusion was that the external acoustic route can be used as the promising route for drug targeting to the brain in the treatment of depression. Madhav et al. [14] describe the formulation of chlorpromazine bionanogel by using the isolated biopolymer as a bioretardant from *Prunus amygdalus* [44]. The prepared bionanogel was evaluated for the delivery of chlorpromazine targeting to the brain. The nanoparticles were prepared by the solvent evaporation method. The formulated bionanogel were evaluated for the t50%, *in-vitro* release, *in-vivo* release study, and pharmacokinetic study. FA8 (1:15) was selected as the best formulation. Madhav et al. [6] researched the development of nanosized duloxetine via external acoustic meatus. The bionanosuspension was developed by using the biopolymer from the berries of *Piper nigrum*. The prepared bionanosuspension was evaluated for the different parameters like ph, % transmittance, content uniformity, and in vitro drug release and ex Vivo study. The obtained results were found to be significant for the treatment of CNS disorder. The drug was found to be targeted to the brain insignificant amount and this rote was found to be suitable for the delivery of duloxetine and in the treatment of depression.

Tyagi et al. [28, 45–47] researched on a new novel innovative approach for the development of the fluvoxamine-loaded bionanosuspension. The bionanosuspension was prepared by using the isolated biopolymer from the *Santalum album*. The biopolymer was characterized for i*n-vitro release*, t50%, r2 values, and kinetic study to know the drug release mechanism. The results were evaluated for identifying the best fit model in drug release. Thus it was concluded that the isolated biopolymer can be suitably used for the development of stable drug-loaded bionanosuspension [16, 48–50].
