Target product profile for new medicine made from Klotho
Characteristics of medicine
Medical usage
Product development considerations and assumptions
Indications
For the prevention of kidney diseases due to aging. Age above 60 years can be considered. (Neyra 2017,41-19)
Kidney diseases are common in aging. It begins at the age of 60. Kidneys also turn out to be older when years go by and cause various kidney diseases in human. Kidney disease may lead to renal failure which is considered to be a serious complication in aging. Recent research shows that kidney disease affects more elders than cancer. Kidneys disease accompanies various other diseases like increased blood pressure, Kidney failure followed by heart failure and in many cases it is fatal. Kidney disease is mostly associated with Diabetes and hypertension which is considered to be other age-related diseases. Studies show that prevention of kidney disease in aging may increase the life span of a person. ( Mallappallil et al. 2014,525)
Contra-Indication
As it is a body protein, it can be used for all, above the age of 60. No contraindications recommended.
As klotho protein is the enzyme secreted in our body, no adverse effects or contraindications are observed in the recent researches. Both theoretically and practically klotho protein proves that it is the beneficiary protein. But when used for chronic kidney disease patient two aspects have to be considered. High potassium diet and intake of vitamin D supplement may influence the klotho protein administration(Hu et al. 2010)
Target Population
Klotho protein has an anti-aging property. It can be used for all the elderly people above the age of 60. Particularly it deals with kidney disease in old age. Since it can be applied to elderly people with kidney disorders.
Kidney disease is always associated with various chronic diseases like diabetes, hypertension and heart disease. Treating or preventing kidney disease will reduce the complications of other chronic diseases due to aging. It also increases the life span and also provides harmony in the process of aging.
Safety precautions
Klotho protein is safe to administer in soluble form.
Klotho protein regulates the metabolism of phosphate, calcium, and potassium. It is a safe and effective way to protect vital organs like the kidney and brain. Studies show that a soluble form of Klotho protein is safe to administer for men and women above the age of 60. But as for other medications, continuous monitoring is recommended. Monitor the levels of calcium, phosphate, and potassium. Vital signs also have to be monitored(Hu et al. 2012, 2650-2657)
Measures of Efficacy
Various studies show that people with end-stage kidney disease had less Klotho protein in the blood and urine. (Hu et al.2010)
Experimental study on kidney injury shows that absence of Klotho protein leads to ischemia in kidneys. Another study shows that creatinine level in urine is normalized with Klotho protein. Studies also prove that Klotho protein prevents the calcium deposition or calcification in heart, kidney and blood vessels. An experimental study shows that it is an effective way to treat kidney injuries also. Laboratories created an ELISA Kit to measure the level of klotho protein in the blood. On Investigation it has generated higher readings on the fresh blood samples and lower reading in the delayed samples or the stored one. Due to the variable blood result, further research needs to be executed. (Hu et al. 2010)
Dose regimen A single dose is Advisable
Klotho protein is available in the form of soluble form, vaccine form, gene therapy, and molecule drug form. It has to be administered only on the advice of the physician. Since it is related to the metabolism of minerals like calcium, phosphate, and potassium. It also influenced the high potassium diet and intake of vitamin D supplement.
Duration of Action
Duration of action differs according to the form of klotho protein administered.
Since Klotho protein is an enzyme the duration of action is limited for few hours only. Duration of action depends on the form of klotho protein used. Duration of action for gene therapy is longer than the other for klotho protein. (Tan et al. 2014, 439-449)
Route of Administration
Oral and Intra-muscular
Klotho protein supplement is available in 20 ug/vial. Gene therapy and vaccine form of klotho protein is administered as injections.
Product storage
Advised to store at 4 degrees C.
Medication has to be stored at 4degree C until the reformation. Once reformation is over medicine need to frozen at – 20 degree for the long term storage.
To provide the details about the Klotho protein this includes the advantages and disadvantages and the scope in the pharmaceutical industry. It also discusses alternative medicines with anti-aging property and healing properties for chronic kidney disease (Mallappallil et al. 2014, 525)
Summary of the task: Klotho protein is the natural form of protein with the anti-aging property. The protein delays the aging and promotes the functions and health of the vital organs like kidneys and brain. Mainly it promotes the health of the kidney and helps the host to recover soon from the kidney injuries. So there is a great demand for the Klotho protein among old age people. Investing in this medicine will bring a revolution in the pharmaceutical industry.
Advice: According to researches done on the klotho protein, it states that Klotho protein is an anti-aging protein full of medical benefits for the old age people. Klotho protein mainly improves the function and health of the vital organs like kidneys and brain. It benefits the kidneys by preventing from aging and kidney failure. But before investing in the klotho protein for the business purpose few points need to be considered. The researches on the klotho protein are limited and proven studies are not available. Observational studies are done only for the small group. An additional difficulty is the lack of tools and standardized method to measure the circulating klotho. The available method of measuring the circulating klotho protein is providing variable results. (Neyra 2017, 41-19)The actual function of Klotho protein in kidney disease is unknown. Exploring alternative anti-aging medicines will provide choices to the investors, which will bring out the best medicine to treat aging and age-related disease conditions like chronic kidney diseases.
Reasons for your advice: Klotho protein is believed to be the benefiter protein. But an Experimental study shows the variable result and readings. Laboratories created an ELISA Kit to measure the level of klotho protein in the blood. On Investigation it has generated higher readings on the fresh blood samples and lower reading in the delayed samples or the stored one. (Neyra 2017, 41-19) The reliable study is not done to prove the function of the klotho protein in kidney disease. Klotho protein has many forms which include circulating klotho, complex klotho, secreted form, a linked form of klotho. The functions and right method to measure the klotho form has to discover. It has been identified as factors like phosphate-rich diet, intake of vitamin D supplementation. (Neyra 2017, 41-19) It also influences certain medication, which is not identified in the observational or experimental studies. Nicotinamide adenine dinucleotide is the alternative medicine suggested to slow down the aging process. Astragals Chinese herbs are two alternative medications suggested to treat the age related disease like chronic kidney disease.. Nicotinamide adenine dinucleotide is the co-factor found in the cells. It has an anti-aging property (Kitada et al. 2013). Various proven studies are available with an accurate research finding. Another option to treat chronic kidney disease due to aging is Astragals, a Chinese herb. (Li et al.2005)Proven studies are available to justify that Astragals has enormous health benefits for the kidneys. Researches show that it prevents the aging of the vital organs. It is also called a ruler drug in the treatment of chronic kidney disease. Studies also prove that it is the safest drug to administer for elderly people.
Advantages and disadvantages of developing a new medicine
- Nicotinamide adenine dinucleotide
- Astragals a Chinese herbs
- Nicotinamide adenine dinucleotide is the co-factor found in the cells with anti-aging property
- Astragal is the Chinese herb with enormous health benefits specifically it treats chronic kidney disease due to aging.
- Nicotinamide adenine dinucleotide therapy costs $200 per month
- Astragal herb is cost effective
- Can be administered as IV infusion
- Astragal Herbs can be administered as food or supplement
- Proven researches are available for its anti-aging property
- Proven research studies are available to support healing properties for the chronic kidney disease
- No side effects are reported
- Less or no side effects are reported
- The right method to measure the accuracy or the range in the blood is reliable
- The right method to measure the accuracy is available
- Not influenced due to intake of any medication or supplement.
- Not influenced by the intake of specific food or medicine.
- It benefits the aged population. It acts as an anti-aging agent whereby it lessens the age of vital organs.
- Astragals herb is an anti-aging herb found in China. It is also called as a ruler drug to treat chronic kidney disease
- The investigation provides the accurate result on measuring Nicotinamide adenine dinucleotide
- Since it is a herbal product, investigation and blood tests are not required to measure the level.
Summary of the task: Klotho is the anti-aging protein bound in the human body. It has various medical benefits which increase the life span of the human. It also increases the life span of the vital organs like the kidney and brain. Klotho protein benefits the old age people to overcome chronic kidney disease. An investor group is interested to invest in the companies involved in the invention of new medicine using klotho protein. Four different forms of klotho protein are exhibited to the investor to choose the right one for the benefit of mankind. This memo advice helps the investors to acquire details about the advantages and disadvantages of developing new medicine for the treatment of an age-related disease based on four Klotho-related mechanisms.
Advice: Klotho protein can be used as an anti-aging supplement. Administering medication to elderly people is like administering to pediatric patients. The medication has to undergo various studies and accurate results need to derive before administering to the elderly people. So Klotho protein has to administer in the form that is favorable for the elderly people. Klotho protein is available in various forms for the administration. Soluble Klotho protein is the biological product which can be administered as a protein drug. A small molecule drug base is another form of klotho drug which is yet to pass through the lead optimization process. Gene therapy product is the one form of klotho protein that induces the body to produce more Klotho protein. It is also available in the form of the vaccine. Administration of soluble Klotho protein is considered to be the best method to treat age-related disease.
Reasons for your advice: Administration of klotho protein in the soluble form is the best method to treat the age-related diseases in elderly people. (Neyra 2017, 41-19) Various age-related diseases like diabetes, a cognitive disorder due to aging, kidney diseases can be treated using klotho protein gene therapy. It also increases the life span of humans. Chronic kidney disease can be easily treated using soluble Klotho protein. Gene therapy is beneficial for elderly people suffering from cognitive disorders. But it is not a suitable method for people suffering from chronic kidney disease. Even though it is a cost-effective method, it is the one time therapy which is contraindicated for chronic kidney disease patients. Because chronic kidney disease patient may also have cardiac problems. High potassium diet is recommended for cardiac patients who may influence the klotho protein. Elderly woman’s undergone menopause is usually prescribed with vitamin D supplement. Vitamin D supplement influences the function of the klotho protein. So elderly women’s on vitamin D supplement can’t choose the gene therapy method for klotho protein administration. A soluble form of klotho protein is the human-friendly. Presence of any adverse effects can be treated easily. Many Research studies support the administration of soluble Klotho protein for elderly people suffering from chronic kidney disease. As a soluble form of klotho protein is the natural one, less or no side effects are reported. Regular monitoring under the specialized physician is possible on the administration of the klotho protein in the soluble form (Hu et al. 2010).
Advantages and disadvantages of available klotho protein products
- Soluble Klotho protein
- Other klotho protein products
- It is the natural form of klotho protein ( found in the circulating blood stream)
- Other products are mostly unnatural
- It has less or no side effects reported. But it may influenced by the intake of high potassium diet and Vitamin D supplement.
- Side effects are expected as it is an unnatural form. May influenced by the intake of high potassium diet and Vitamin D supplement.
- It is human-friendly and easy to administer
- Administration need more procedure to be followed
- Suitable for elderly people with chronic kidney disease.
- Not a suitable method for elderly people with chronic kidney disease.
- Blood investigation on the Post-administration of medication provides an accurate result
- Blood investigation on the Post-administration of medication results are inaccurate
- Monitoring the patient on the medication administration is simple and painless
- Monitoring the patient on the medication administration has complex procedures
- Continuous monitoring is not recommended
- Continuous monitoring is recommended
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