INTRODUCTION:

Cancer is a disease categorized by uncontrolled proliferation and spread of unusual forms of the body's cells. The branch of medicine concerned with the diagnosis, study, prevention and treatment of cancer is oncology. Cancer may affect people at all ages, but the risk of most varieties rises with age¹. When the cell gets old or gets irreversibly injured, they die and are substituted with new cells.

Nevertheless, occasionally this orderly progression goes wrong; the DNA of a cell can become injured, generating mutations that affect usual cell growth and division. The additional cells may form a mass of tissue termed as tumor. Targeted drug delivery is considered as a method in which drug-carrier complex, delivers drug to the pre-selected cell in a specific manner. The drug should reach the target cells with the maximum concentration or with maximum effect^2,3.

Paclitaxel is used as a drug of choice and first-line therapy for an extensive range of cancers, such as breast, prostate, lung, head and neck, ovarian cancers and AIDS-related Kaposi sarcoma. The first commercially available preparation of paclitaxel on the drug market is taxol. Taxol is a non-aqueous solution of formulated paclitaxel in a equal combination of the solubilizing agent cremophor EL (polyethoxylated castor oil) and dehydrated ethanol, intended for dilution with a appropriate parenteral fluid before intravenous (i.v) infusion^4,5.

Nanoniosomes have been widely employed as drug delivery systems. Nanoniosomes are two layered vesicles usually acquired by the self-assembly of cholesterol and nonionic surfactants, successively by hydration in water⁶. Nanoniosomes have the advantages of biodegradability, stability, bioavailability, biocompatibility, low cost and diversity of available surfactants for their design^7,8,9.Niosomes comprise major components two, comprising cholesterol as well as nonionic surfactants. Cholesterol affords rigidity and proper shape, while surfactants play a chief role in the development of niosomes. The non-ionic surfactants comprise a hydrophilic head (non-polar) and a hydrophobic tail. The families of Spans (Span 20, 40, 60, 80 and 85), Tweens (Tween 20, 40, 60, and 80), and Brij (Brij 30, 35, 52, 58, 72 and 76) are frequently used as non-ionic surfactants in making of niosomes. Niosomes are often used for loading various kinds of drugs. For instance, paclitaxel,¹⁰ acyclovir,¹¹ and enoxacin/gentamicin^12,13 are successfully loaded in niosomes as anticancer, antiviral and antibacterial agents, correspondingly. Nanotechnology is frequently used in every field like fiber, agriculture, electronics, forensic science, science and medical field. Nanoencapsulation of medical drugs (nanomedicines) help to increase the drug efficacy, tolerability and therapeutic index of the corresponding drug. Nanomedicines are also reported to possess enhanced absorption in selected tissue, improvement of intracellular penetration, bioavailability and retention time¹⁴. These targeting capabilities of the drug molecules are increased by architecting careful changes in particle size, surface modification and hydrophobicity. The particle size and size distribution are helpful to determine the interaction with cell membrane, and their capacity to cross the physiological drug barrier.¹⁵

CANCER:

Cancer is an uncontrolled growth of cells resulting in lack of differentiation and ability to attack local tissues and metastasis which are reproduced independently throughout the body. Chemotherapy and radiation therapy are major clinical treatments used for the control of early stages of tumor but these methods has severe side effects. Nature has provided a variety of useful sources, mainly plants for the discovery and progress of drugs against dreadful diseases in humans. Traditional herbs are effective system of treatment of cancer, drugs from medicinal plants are found to be comparatively less toxic and possess side effects¹⁶. Breast cancer ranks second in mortality after lung cancer and spreads fear to women around the world.¹⁷ Cancer treatment options vary greatly depending on the stage of cancer at the time of diagnosis. Radiotherapy and surgery are commonly used in the early stages of breast cancer. Chemotherapy is cancer treatment options at an advanced stage of the disease^18,19. The use of chemotherapy is often limited predominantly due to unwanted side effects and limited choices of anticancer drugs²⁰. Pancreatic cancer stands in the 14^th position cancer. Based on the cancer mortality it stands in the 7^thposition. According to the Globocan database report, there is 458918 cases diagnosed and caused 432242 deaths in the world wide in the year 2018.²¹ The pancreatic cancer’s incidence rate differs from each country. Europe and North American Population were highly affected when compared to other countries²². The smoking habit and low intake of fruits and vegetables are considered to be the major risk factor for development of carcinoma of the pancreas. Age is considered to be a well-known risk factor²³.Diabetes is also a risk factor probably which will lead to the tumor. Cholecystectomy and gastrectomy are also considered to be a possible risk factor.²⁴According to research studies family history also favors the pancreatic cancer.²⁵

Signs and symptoms of cancer:

We should know some of the signs and symptoms of cancer. Fever, skin changes, change in bowel habits or bladder function, sores that do not heal, white patches inside the mouth or white spots on the tongue, unusual bleeding or discharge, thickening or lump in the breast or other parts of the body indigestion, unexplained vaginal bleeding, mouth or tongue ulcer that won’t heal, persist heart burn or indigestion, unusual breast changes, fatigue, difficulty in swallowing, cough, breathlessness, persistent bloating and pain are some of the common symptoms of those persons affected by different types of cancers.

Types of cancer

Carcinomas:

These cells cover internal and external parts of the body like breast, lungs and colon cancer.

Leukemias:

Bone marrow and every so often accumulate in the bloodstream.

Lymphomas:

Lymph nodes and immune system tissues.

Adenomas:

Thyroid, the pituitary gland, the adrenal gland and other glandular tissues

Sarcoma:

It covers the bone, cartilage, fat, connective tissue, muscle and other supportive tissues

Factors affecting cancer:

Radiation:

The radiations are also notorious carcinogens in the developing and developed countries. About 10% of cancer manifestation is due to the radiation effect, both ionizing and non-ionizing. The major causes of radiations are radioactive compounds, ultraviolet and pulsed electromagnetic fields.

Obesity and Lack of physical activity:

Obesity and lack of physical activity are associated with increased risk at various cancer sites, including breast and endometrial cancer.²⁶

Tobacco and Smoking:

In the leading cause of cancers, consumption of tobacco is also one of the key factor. The regular use of tobacco via smoking, and chewing, is responsible for 65% to 85% cancer incidences in men and women, correspondingly.

Alcohol consumption:

The consumption of alcohol has been considered as one of the major reasons of colorectal cancer as per a recent monograph of WHO. Each year, about 9.4% new colorectal cancer cases are recognized due to the intake of alcohol, globally.²⁷

Skin cancer:

It signifies the most frequently occurring carcinoma in human and it is increasing at a rate of one million new cases being quantified every year. Ultraviolet radiation is the key causative factor accountable for its existence. The ultraviolet radiation produces and activates a broad range of molecules in the skin, and some of them act as receptors of ultraviolet radiation including DNA/RNA, reactive oxygen species and numerous other as transcriptional targets. Investigation and study on skin cancer could bring down the suffering patient load in most of the countries throughout the world comprising America, Australia, and Africa as the novel drug delivery system will pave new routes towards its treatment all over the globe.²⁸

Skin cancer is the most common malignant disease found particularly in Caucasians.²⁹ More than a million new cases are reported worldwide each year. The various types of skin cancer are named after the cells they originate from and their clinical behaviour. The most common types are basal cell carcinoma (BCC), squamous cell carcinoma (SCC) (together referred to as nonmelanocytic skin cancers (NMSC)), and malignant melanoma (MM).³⁰

Non melanocytic Skin Cancer:

it is the most common malignancy found in humans. Each year 2-3 million new cases are reported worldwide, 1,3 million of those are found in the USA only.³¹ In Europe, Canada, the USA, and Australia the incidence is increasing by 3-8% per year. The incidence rate is thought to double in the next 30 years.³² The most important etiological factors include UV light, ionizing radiation, and certain chemical carcinogens.

Malignant Melanoma:

Skin melanocytes are cells that produce the skin pigment melanin, and MM affects them specifically. Its incidence is still on the rise in areas with light skinned population that is overly exposed to sun radiation. Development from the retinal, anogenital, and the gastrointestinal tract is rarer. There are multiple MM risk factors. The most prominent etiological factors are constitutional factors, UV light, and other factors.³³

Age:

MM incidence rises with age; However, the average patient age is 62 years. It has to be pointed out nevertheless that MM is still one of the most common cancers in young adults as well.³⁴

Immunosuppression:

Immunosuppression is a MM risk factor, which also declines the patient survival.³⁵

Drugs used for the treatment of cancer:

Crude drugs as anticancer agents:

Beneficial effects of crude drugs are believed to be attributed to plant phytochemicals (various factors in plant foods), such as carotenoids, antioxidative vitamins, phenolic compounds, terpenoids, steroids, indoles, and fibers, etc.³⁶ Crude drugs are the effective elements considered to be responsible for reducing cancer risk. Below we cite several examples of phytochemicals that are used or have the potential for use in cancer treatment. Curcumin, carotenoids, astaxanthin, citrus pectin, mushroom, capsaicin are some of the examples of crude drugs used as anticancer agents.

Paclitaxel:

Paclitaxel (Taxol), is an effective and normally used cancer drug approved for handling a variety of cancers, and it is under evaluation for the treatment of alzheimer’s disease and coronary heart disease also. As such, it is a crude drug success story, it is isolated from the bark of the slow growing and endangered Pacific yew Taxus brevifolia (from the tree family Taxacae). Paclitaxel is considered as terpenoid, a member of a natural organic family of chemicals. It was first extracted from the Yew tree in US in 1971 and, by 1992, received approval from the US Food and Drug Administration (FDA) for clinical use. Today, paclitaxel has proved effective for the treatment of various types of cancers, such as ovarian,^{37, 38, 39,
40} breast⁴¹ lung ^{42, 43}esophageal ⁴⁴ and liver cancers.⁴⁵ Unique activities of paclitaxel are that it binds to β-tubulin in the microtubule specifically and reversibly with a stoichiometry of almost one (relative to the α, β-tubulin dimer),^46,47 inhibits cell division, blocks cell mitosis, stabilizes cytoplasmic microtubules, and induces the formation of the characteristic microtubule bundles in cells.⁴⁸

Preparation of Niosomes:

Bubble method:

It is a single step preparation method of niosomes. Organic solvents are not used in this method. The bubbling unit contains round bottom flask with 3 necks positioned in the water bath. Water- cooled reflex is in the first neck, the thermometer is in the second neck to the check the temperature and the third neck for the nitrogen supply. The cholesterol and surfactant is dispersed in the buffer (7.4) at 70°C. The dispersed mixture is mixed for 15sec with high shear homogenizer and immediately afterwards bubbled at 70°C using nitrogen gas.⁴⁹

Hand shaking method:

In this method, surfactant: cholesterol (150micro.mol.) mixture was dissolved in 10ml diethylether in RBF. The ether is evaporated under vacuum at room temperature in rotary evaporated. Upon hydration the surfactant swells and is peeled off the support in to a film. Swollen amphiphiles eventually fold to form vesicles.⁵⁰

Extrusion method:

In this method, niosomes were prepared using C16G2, a chemically defined non -ionic surfactant by extrusion through a polycarbonate membrane. These studies not only demonstrate the effect of number of extrusions on vesicles size but also the effect of size on encapsulation of drug.

Sonication method:

The mixture of cholesterol and the surfactant are dispersed in an aqueous solution. The solution is transferred to a vial and probe sonicated at 60°C for 3mins. The titanium probe is used for sonication. Multilamellar vesicles are formed by this method.

Ether injection:

In this method, slow injection of surfactant: cholesterol (150micro.mol.) in 20ml ether through a 14-gauze needle (25ml/ min.) in preheated 4ml aqueous phase maintained at 600c. The ether solution was evaporated using rotary evaporator, after evaporation of the organic solvent it forms single layered vesicles.⁵¹

Niosomes:

Niosomes are categorized depending on the number of sizes, bilayers and method of preparation.

Types of Niosomes:

Bola surfactant containing niosomes:

These niosomes are prepared from omega hexadecylbis-(1-aza-18 crown-6) (bola surfactant): span- 80/cholesterol in 2:3:1ratio.^{52 53}

Proniosomes:

Proniosomes are made from the carrier and surfactant mixture. After the hydration of proniosomes, niosomes are produced.

Aspasomes:

Aspasomes are produced from the mixture of acorbylpalmitate, cholesterol and exceptionally charged lipid diacetyl phosphate prompts the arrangement of vesicles. Aspasomes are first hydrated with water/fluid arrangement and afterwards it was subjected to sonication to get the niosomes. Aspasomes have likewise been employed to diminish scatter, caused by reactive oxygen species as it has innate cell reinforcement property.

Niosomes in carbopolgel:

Niosomes were prepared from drug, spans and cholesterol then it is incorporated in carbopol-934 gel (1%w/w) base comprising propylene glycol (10% w/w) and glycerol (30% w/w).

Deformable niosomes:

The combination of ethanol, non-ionic surfactants and water produce the deformable niosomes. These are smaller vesicles and easily pass through the pores of stratum corneum, which leads to elevated penetration efficiency. It can be used in topical preparation.⁵⁴

These are also categorized rendering to the number and size of bilayer given below,

i) Multi Lamellar Vesicles (MLV):

Multilamellar vesicles are the most widely used niosomes, it consists of a number of bilayers. The rough size of vesicles is 0.5-10μm diameter. It is simple to make and are mechanically stable upon storage for longer periods.

ii) Large Unilamellar Vesicles (LUV):

These are the large unilamellar vesicles which are having a high aqueous/lipid compartment ratio, so that larger volumes of bio-active materials can be entrapped. They are 0.1µm to 1µm in diameter.

iii) Small Unilamellar Vesicles (SUV):

These vesicles are commonly prepared from multilamellar vesicles by the method of french press, sonication and extrusion method. The size is 25 to 500 nm in diameter.

APPLICATIONS:

Niosomes has its applications in various fields

Cancer Therapy:

The drugs that are mostly used in the cancer therapy through niosomal drug delivery are doxorubicin HCL, methotrexate, bleomycin, vincristine, daunorubicin HCL. By niosomal formulation, doxorubicin has augmented level in tumor cells, serum and lungs. It also decreases the proliferation of tumor cells and also increases the life span of tumor bearing mice. Methotrexate entrapped by niosomes gives elevated plasma level as well as increases the half-life of drug that gives extended action of the drug.

As Carrier:

Niosomes being the vesicles can easily permeate to oxygen and the hemoglobin dissociation curve is modified similarly to non-encapsulated hemoglobin. So, they are used as the carrier for hemoglobin.⁵⁵

Transdermal Drug Delivery:

The delivery of drugs through skin indicates the transdermal drug delivery system. The benefit of this drug delivery system is it does not undergo the first-pass metabolism. The skin acts as the barrier for the penetration of drugs, this downside can be overcome by the niosomal preparations.

Mechanism of Niosomal Skin Delivery:

The mechanism followed by the niosomes for transdermal drug delivery system is:

· Diffusion through stratum corneum layer.

· The niosomes loses the cells of stratum corneum which increases the permeation of drugs.

· The lipophilic drugs cross the stratum corneum by aggregation, fusion and adhesion.

· The non-ionic surfactant enhances the permeation and this leads to improved drug permeation through skin.⁵⁶

CONCLUSION:

The present work deals with an up-to-date review on the anticancer drugs and niosomal drug delivery system. In future niosomes would be promising carriers for drug delivery systems. Nano-niosomal-based drugs provide enhanced permeability and efficacy, less side effects and may facilitate drug delivery into the cells. Today, with the emergence of new chemotherapy treatments (including biological agents, hormones and molecular targeting agents), the development of useful methods is required for preclinical and clinical studies in future. However, as is evident from the research and review papers presented in this Subject on “Anticancer Drugs”, significant efforts are being made to develop and improve cancer treatments and to translate basic research findings into clinical use, resulting in improvements in survival rates and quality of life for cancer patients. Hence, the objective of this review is to progress the present-day researchers in the direction to undertake further studies on anticancer activity.

CONFLICT OF INTEREST:

The authors declare no conflict of interest.

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Received on 19.05.2021 Modified on 22.06.2021

Research J. Pharm. and Tech. 2022; 15(6):2849-2854.

DOI: 10.52711/0974-360X.2022.00476