Everything about Cetilistat powder
Cetilistat(Oblean) powder video
I.Cetilistat(Oblean) powder basic Characters:
|Storage Temp:||Room Temperature|
Cetilistat powder is raw material of Cetilistat powder, also known as Cetislim,always be used to make weight loss product, treat obesity. which is white powder with CAS No. 282526-98-1.
|Name:||Cetilistat powder, cetislim|
|Melt Point:||72.0 to 76.0 °C|
|Cetilistat powder powder Color:||White or off white powder|
The clinical efficacy and safety of Cetilistat powder has been demonstrated in a series of Phase II trials. A Phase IIb clinical trial in 612 clinically obese diabetic patients showed that over a 12-week treatment period, Cetilistat powder 80mg and 120mg promoted significant weight loss compared with placebo (3.85kg and 4.32kg versus 2.86kg respectively), thus meeting the trial’s primary endpoint.
- It does not act on the central nervous system;
- Fighting obesity;
- Does not take away the appetite;
- It helps reduce weight and improve body composition;
- Does not cause mood changes such as anxiety and nervousness;
- Its use is released by ANVISA.
Cetilistat powder(Cetislim) is an anti-obesitiy medicine which helps promote weight loss by inhibiting the enzyme called pancreatic lipase. This enzyme is secreted by the pancreas and normally acts inside the intestine where it helps to breakdown fat and triglycerides. By preventing the activity of this enzyme, the hydrolysis of triglycerides (types of bad fats) is partially prevented. This results in a significantly reduced amount of free fatty acids and fats being absorbed into body, especially after fatty foods have been consumed.
Any remaining undigested fat is unable to be absorbed and is instead eliminated from the body as faeces. Treatment can help to lessen visceral fat and bodyweight, however patients should note that the use of medication to treat obesity needs to be accompanied by dieting, exercise and other lifestyle changes. This will help to minimize the risk of developing chronic diseases associated with being overweight, such as type 2 diabetes.
Cetilistat powder dosage is provided as 60mg strength capsules for administration orally. The medicine is taken with meals to ensure that it can work while the food is being digested, so that the absorption of fat from the diet can be effectively reduced. Your physician will advise you on how much medicine to take with each dose, as well as the required daily dosage. It is very important that you adhere to these instructions. Do not take more than your physician tells you to take.
Patients undergoing treatment for obesity with Cetislim (Cetilistat powder) powder could suffer from side effects. You must inform your physician if this happens. Some examples are given here:
- Fat in stool
- Abdominal cramp
- Flatus with discharge
- Oily spotting
- Bowel incontinence
- Abdominal Pain
- Soft stools
- Nasal congestion
- Frequent defecation
- Pain in the stomach
Although mild reactions are generally considered to be more common, serious adverse events may also occur. Consult your physician immediately should this occur.
The solubility of Cetilistat powder in neat solvents of acetone, isopropanol, acetonitrile and water were determined experimentally by using the isothermal dissolution equilibrium method within the temperature range from (278.15 to 323.15) K under atmospheric pressure of 101.1 kPa. At the fixed temperature, the mole fraction solubility of Cetilistat raw powder was greater in acetone than in the other three neat solvents. They ranked as acetone > isopropanol > acetonitrile > water. The obtained solubilities were correlated with Apelblat equation. The largest value of relative average deviation was 0.86 × 10− 2, and of root-mean-square deviation, 15.55 × 10− 4. Furthermore, the preferential solvation parameters (δx1,3) of Cetilistat powder in co-solvent mixtures of acetone (1) + water (2), isopropanol (1) + water (2) and acetonitrile (1) + water (2) were derived from their thermodynamic properties by means of the inverse Kirkwood–Buff integrals method. The values of δx1,3 varied non-linearly with the co-solvent (1) proportion in all the aqueous mixtures. The preferential solvation parameter was negative in water-rich mixtures but positive in intermediate composition and co-solvent-rich mixtures. In the latter case, it was conjecturable that Cetilistat powder was acting as a Lewis acid with co-solvent molecules. The co-solvent action might be related to the breaking of the ordered structure of water around the polar moieties of Cetilistat raw powder which increased the solvation of this drug. The solubility data and thermodynamic study expanded the physicochemical information about Cetilistat powder in binary solvent mixtures, which was required in the pharmaceutical and chemical industries to save time and money in the optimization of the solubilization and/or crystallization process designs.
Several researches claim that Cetilistat powder tablet it works to inhibit the absorption of fat. Its effect is analyzed mainly by the amount of fat present in the feces of people who underwent treatment with the drug.
In a study published in the British Journal of Clinical Pharmacology, volunteers who underwent treatment with Cetilistat raw powder showed a considerable increase of fat in their feces compared to the group and did not take the drug. The same study concluded that treatment with Cetilistat powder is effective to prevent the absorption of intestinal fat in healthy subjects who received a controlled diet.
Clinical trials conducted by the Japanese laboratory Takeda, maker of Cetilistat raw powder showed that people who underwent treatment with the drug for 12 weeks lost more weight than the control group that received only a placebo.
The study of 612 obese patients, the group receiving Cetilistat powder at a dose of 120 mg kg 4:32 lost on average, while the group that received 80 mg Cetilistat raw powder eliminated 3.85 kg. The control group, which received only a placebo lost 2.86 kg in 12 weeks.
That is, there was a weight loss of at least 25% more in groups using the Cetilistat powder than the group maintained the same diet but did not receive the medicine.
Cetilistat powder is a weight loss powder used in combination with a low calorie diet. It works by blocking a substantial amount of fat from being digested and absorbed into the body. This weight loss powder is classified as a lipase inhibitor and it works directly on the digestive system where it blocks the action of a lipolytic enzyme called lipase. These lipases are what the body uses to digest the fat.However, when this medicine is administered alongside a meal, it binds to the lipases, thereby inhibiting them from breaking down the fat. Fats which are not hydrolyzed are instead excreted in the feces, resulting in increased fecal fat excretion and reduced fat absorption. When used together with a reduced calorie diet, it can help improve weight loss and make it easier for overweight patients to get back in shape, thereby boosting the chances of successful weight loss. Its using way is same as older orlistat powder by inhibiting pancreatic lipase.
The growing prevalence of obesity has stimulated the search for drugs to treat this condition. Various therapeutic strategies have been explored, including:
- Serotonin and noradrenaline reuptake inhibitors (anorectic agents)
- Lipase inhibitors
- b 3-adrenoreceptor agonists
- Leptin agonists
- Melanocortin-3 agonists
- Endocannabinoid receptor antagonists
Cetilistat powder is a lipase inhibitor, with a similar mode of action to Roche’s anti-obesity medication orlistat (Xenical®) which received regulatory approval in 1997. These drugs act in the gastrointestinal tract to inhibit lipases, enzymes involved in the breakdown of dietary fats. By inhibiting the breakdown and subsequent absorption of fats from the gut, lipase inhibitors reduce fat intake and calories, thus aiding weight loss.
- Do not stop taking the medication abruptly unless instructed by the doctor. Stopping the medication suddenly may cause the illness to return.
- Avoid consumption of alcohol as it may alter the absorption of
- Keep the medication out of reach of children.
- You are advised not to take Cetilistat powder if
it has passed the expiry date of the medicine printed on the pack.
the foil or packaging is torn or shows signs of tampering or there is discolouration.
- Inform the doctor if you have any history of allergic reaction with the usage of
- Tell your doctor if you become pregnant while taking Cetilistat powder.
- Inform the doctor if you are taking any other drugs, OTC medications, herbal products or nutritional supplements
It is not recommended to take more than 3 capsules within 24 hours.
Immediately proceed to your nearest emergency department if you suffer an allergic reaction. Symptoms usually associated with such a reaction include difficulty breathing or swallowing, chest tightness, swelling, skin rashes, and hives.
Cetislim is not always suitable for all patients. Always consult your health care provider prior to using this medication if you are pregnant, breastfeeding, trying to conceive, using any other medication (prescription or non-prescription), using any herbal products or supplements, or if you have any allergies or other health problems.
The correct dosage of Cetilistat powder and prescription commonly depend on the patient and the condition being treated. Do not adjust your dosage without the approval of your health care provider. This product is only for use as prescribed and instructed.
Cetilistat powder Receipes Formula:
02# capsule filling tools 100mg/capsule Cetilistat powder 150g
Cetilistat powder dose: 60mg/dose
100mg/capsule-Cetilistat raw powder 60mg/dose=40mg/dose corn starch
Cetilistat powder 60mg/dose:40mg/dose corn starch=3:2
150g Cetilistat raw powder: 150mg corn starch powder=3:2
150g + 100g =250g 250g=250,000mg
250,000mg ÷ 100mg/capsule=2500capsules(Cetilistat powder)
Cetilistat powder, a novel gastrointestinal lipase inhibitor, appears to be as effective in the management of obesity and its comorbidities as another lipase inhibitor, orlistat, while demonstrating better tolerability, according to two phase 2 randomised, double-blind, placebo-controlled, 12-week studies.
“Lipase inhibition has proven efficacy in obese patients and in obese patients with diabetes,” said Tom, dean, faculty of health, University of East Anglia, Norwich, United Kingdom, who presented the two studies on behalf of the Cetilistat raw powder European Study Group here at the 15th European Congress on Obesity (ECO).
The first study investigated the use of Cetilistat powder in 372 obese patients with a body mass index (BMI) > 30, in centres throughout Europe. All patients received intensive dietetic counselling throughout the study and consumed a prescribed diet that was calculated to be approximately 500 kcals below their weight-maintaining diet. In addition, patients were given 60, 120, or 240 mg of Cetilistat raw powder, or placebo, at mealtimes, three times daily.
Significant weight loss was achieved in all treatment groups at 12 weeks, with a 3.5-kg reduction in weight achieved with 120 mg Cetilistat powder three times daily versus placebo (P <.05).
“Cetilistat powder was effective in inducing weight loss in 12 weeks of study,” Dr. Tom said in a presentation on April 23rd. “In addition, there were significant reductions in waist circumference.”
In the second study presented by Dr. Tom, the researchers enrolled 612 obese subjects with type 2 diabetes, who were taking metformin. Many of the patients were also on statins, and about a third were also taking antihypertensive medication.
As in the previous study, patients received a hypocaloric diet and one of three different doses of Cetilistat raw powder (40, 80, or 120 mg), or placebo. In addition, a fourth study group was randomised to 120 mg of orlistat 3 times daily.
Dr. Tom said that significant weight reductions were achieved in all treatment groups, with approximately 35% of subjects on the highest Cetilistat powder dose achieving a weight loss of about 5% of their initial body weight or more. In addition, there were statistically significant reductions in glycosilated haemoglobin (HbA1c) over 12 weeks.
Although the efficacy data were comparable between Cetilistat rawpowder and orlistat, considerable differences emerged between these two drugs regarding their tolerability profiles, according to Dr. Tom.
Overall, patients treated with orlistat had nearly twice as many serious adverse events — primarily gastrointestinal — leading to treatment discontinuation than in the Cetilistat powder group. The rate of severe adverse events leading to discontinuation was comparable between the placebo group and those receiving Cetilistat powder.
On the basis of these results, Dr. Tom concluded that Cetilistat raw powder has a favourable tolerability profile, and it is safe and efficacious in the management of obesity and its comorbidities.
Funding for these studies was provided by AASraw Biochemical Powder, the manufacturer of Cetilistat powder.
16. What is the Phase III Development Plan of Cetilistat powder weight loss Powder?
Cambridge, UK — March 6, 2008 — Alice (LSE: AZM) today announces that FDA has agreed the remaining two protocols for its Phase III development programme for Cetilistat powder under the Special Protocol Assessment (“SPA”) procedure and recommended that Alice open a separate diabetes IND.
Cetilistat raw powder is Alice’s metabolic product under development for the treatment of obesity and associated co-morbidities, including type 2 diabetes. It is a gastrointestinal lipase inhibitor that blocks fat digestion and absorption, leading to reduced energy intake, and thus weight loss.
Following successful end of Phase II discussions, FDA approved Alice ’s outline plan for the Phase III clinical development programme of Cetilistat powder . This comprises three 12 month studies involving:
(i) obese patients without co-morbidities and obese patients with treated or untreated co-morbidities (other than type 2 diabetes);
(ii) obese patients without co-morbidities and obese patients with untreated co-morbidities (other than type 2 diabetes); and
(iii) obese patients with treated type 2 diabetes and who may have treated or untreated other co-morbidities.
In April 2007, Alice announced that the protocol for the first study was agreed with FDA under the SPA procedure. The protocols for the second and third studies have now also been agreed with FDA under the SPA procedure. The second study will involve a direct comparison with Xenical ®, as well as placebo.
FDA issued draft guidance on the development of diabetes drugs at the end of February 2008. Under this guidance, it has acknowledged that improvement in HbA1c has become the standard surrogate outcome measure for diabetes studies.
Evidence of the safety and efficacy of Cetilistat raw powder has been established through extensive Phase I and Phase II studies. Furthermore, in Phase II studies, Cetilistat raw powder was shown to cause statistically significant weight loss, compared to placebo and, in clinically obese diabetic patients, to cause statistically significant reductions in HbA1c.
FDA has corresponded directly with Alice in relation to its planned Phase III programme and recommended that Alice open a separate diabetes IND for Cetilistat powder , since it is not now requiring that a drug’s effect on glycemic control be independent of its effect on body weight in order for the drug to be considered for a stand alone diabetes indication. Although FDA has publicly stated that long-term safety studies lasting longer than one year may be required for some therapeutics in which substantial safety issues or questions arise, it has indicated that a 12 month study would be sufficient for a pivotal study with Cetilistat raw powder for obese diabetics.
The Phase III development programme for Cetilistat powder , which provides a clear route to registration as an obesity product, is now ready to commence following the conclusion of a commercial deal. There continues to be significant partnering and development interest in Cetilistat raw powder ; discussions are ongoing.
Commenting on the announcement, Chief Executive Officer, Tim McCarthy said:
“I am delighted with this news. Not only is the regulatory pathway for Cetilistat powder as an obesity product firmly established with FDA, giving clarity to potential partners with respect to the route to market for Cetilistat raw powder , but the opportunity to develop the market for Cetilistat powder further by opening an IND for diabetes is of great commercial significance.”
Special Protocol Assessment (SPA)
In conjunction with the reauthorisation of the Prescription Drug User Fee Act of 1992 (PDUFA) in November 1997, FDA agreed to specific performance goals for special protocol assessment and agreement. These goals provide that, upon request, FDA will evaluate certain protocols (i.e. carcinogenicity protocols, stability protocols, and Phase III protocols for clinical trials that will form the primary basis of an efficacy claim) to assess whether they are adequate to meet scientific and regulatory requirements identified by the sponsor (in this case Alice).
Once FDA and the sponsor concur, under the Special Protocol Assessment, the Agency documents agreement that the design and planned analysis of a study adequately address objectives in support of a regulatory submission.
As stated in the PDUFA goals for Special Protocol Assessment, having agreed to the design, execution, and analyses proposed in protocols reviewed under this process, the Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident.
Cetilistat raw powder
Alice ‘s metabolic product, Cetilistat powder , is being developed for the treatment of obesity and associated co-morbidities (including type 2 diabetes). It is a gastrointestinal lipase inhibitor that blocks fat digestion and absorption, leading to reduced energy intake, and thus weight loss. It is distinct from most other anti-obesity agents as it does not act on the brain to reduce appetite, but acts peripherally. The compound remains in the gastrointestinal tract with no significant absorption into the body. It can, therefore, be expected to have a superior risk-benefit profile to centrally acting drugs. Accordingly, Cetilistat raw powder is not subject to the safety concerns generally associated with centrally acting drugs.
Roche ‘s Xenical is an approved obesity product and is also a peripherally acting lipase inhibitor. However, in clinical trials, Cetilistat powder has been demonstrated to be much better tolerated than Xenical which has side effects that detrimentally affect patient compliance.
17. Frequently Asked Questions about Cetilistat powder raw material Powder
A. Is it safe to alter the dose of Cetilistat powder?
No, it is not advisable to alter the dose prescribed. Consult your doctor for dose-related queries.
B. Is it normal to experience flatulence with Cetilistat raw powder?
Yes, flatulence is Cetilistat powder side effects. However, consult your physician.
C. Can I recommend this medication to others?
It is not advisable to recommend drugs to others as the severity of the condition and medical history is not same for every individual.