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Semaglutide 1mg soluble oral patch
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Our compounded Semaglutide Transmucosal Buccal Film offers an innovative and convenient solution for weight management and blood sugar control. Designed for ease of use, this buccal film allows for rapid absorption of semaglutide through the mucous membranes in the mouth, providing effective regulation of appetite and glucose levels. Ideal for those seeking an alternative to traditional injections, this formulation helps promote feelings of fullness, reduce hunger, and support sustainable weight loss when combined with a healthy diet and regular exercise. Discover a new way to manage your weight and improve your health with our semaglutide buccal film.
Dr Sarah Thornton MbChB, Coaching Academy diploma with distinction
Medical coaching
What is Semaglutide?
Semaglutide belongs to a class of drugs known as glucagon-like peptide-1 receptor agonists (GLP-1 RAs). It uses the incretin hormone system to induce its weight loss effects. Glucagon-like peptide 1 (GLP-1) is a hormone released from the proglucagon gene in L-cells of the distal small intestine and colon in response to food.1 The GLP-1 hormone binds to GLP-1 receptors in tissues such as the pancreatic beta cells, gastric mucosa, kidney, heart, and hypothalamus.2 It stimulates insulin release and secretion in hyperglycemic states while inhibiting glucagon release in both hyperglycemic or euglycemic states slows gastric emptying, and reduces food intake.3 The half-life of GLP-1 is 1 to 2 minutes due to N-terminal degradation by the enzyme dipeptidyl peptidase 4 (DPP-4).4,5
Hence, the synthetic GLP1-1 agonists have been specially formulated to resist the degradative effects of the dipeptidyl peptidase 4 (DDP-4) enzyme, thus increasing its half-life. Semaglutide is an example of a long-acting GLP-1 receptor agonist with a 94% homology with native GLP-1. However, the structural modifications made to semaglutide facilitate reversible binding to albumin, reducing both renal clearance and the degradative effects of DPP-4 while facilitating high affinity for the GLP-1 receptor.6 These modifications have resulted in slower degradation and increased the half life up to 184 hours, providing the convenience of once weekly dosing.7
What is the Compouned Semaglutide transmucosal buccal film?
APC Labs has compounded a unique formulation of semaglutide to facilitate better patient compliance with reduced side effects. The transmucosal film allows the semaglutide to be administered via the buccal route. The film is specially formulated with mucoadhesive properties, which means that when it comes into contact with the buccal mucosa, it adheres immediately to the inside of the mouth, so there is no need to hold it in place. Once the semaglutide transmucosal film is in contact with the inside of the side of the mouth or placed under the tongue, it rapidly begins to dissolve.
Using this buccal dosage route means that the active ingredient, semaglutide, reaches the bloodstream without passing through the stomach, small intestine, and liver. It bypasses the acidic environment of the stomach and first-pass metabolism, which means more of the active ingredient reaches circulation.
The semaglutide transmucosal 1mg buccal film comes in a strip of ten films and is supplied in a folded plastic blister strip. This novel formulation does not require storage in the fridge and it can be stored at room temperature, so long as it is stored within the folded plastic blister and not exposed to direct sunlight or extremes of temperature. The enhanced stability of the transmucosal film and the ease of use make it an ideal substitute where cold chain conditions cannot be guaranteed or in patients who are needle phobic.
As compounding pharmacists at APC Labs, we are committed to providing high-quality, patient-centred care. We understand the importance of personalised medication solutions and are here to support patients and prescribers with any questions regarding our Semaglutide 1 mg Transmucosal buccal film. Please do not hesitate to contact us for further information or guidance on this innovative formulation.
What is the active ingredient in the compounded Semaglutide 1mg transmucosal buccal film?
The active ingredient in the semaglutide transmucosal buccal film is Semaglutide 1mg.
What is Semaglutide 1mg transmucosal buccal film used for?
The Semaglutide 1 mg transmucosal buccal film is a specialised medicine for treating obesity. It is licensed for the treatment of weight reduction in obese individuals defined as having a body mass index (BMI) ? 30 kg/m2 or ?27 kg/m2 with obesity-related co-morbidities such as type 2 diabetes, hypertension, or dyslipidaemia.
How does the Semagltuide 1mg transmucosal buccal film work?
Semaglutide achieves weight loss via several mechanisms. It promoted insulin secretion from the beta cells in the pancreas while decreasing glucagon secretion.8 Since it suppresses the appetite by inducing feelings of fullness and satiety, it produces weight loss effects via a reduced energy intake with minimal effects on energy expenditure.9 Rodent studies have demonstrated that semaglutide has direct and indirect effects on the CNS pathways involved with both hedonistic and homeostatic control of appetite. 10 The gastrointestinal effects have also been hypothesised to contribute to the weight loss effect, such as the delayed gastric emptying, however studies have shown that these effects are minimal.11
The semaglutide has been formulated into a transmucosal buccal film with mucoadhesive properties that allow it to adhere to buccal mucosa upon contact. It rapidly dissolves after attaching to the buccal mucosa, facilitating absorption into the bloodstream. The buccal administration facilitates immediate absorption into the rich vascular bed supplying buccal mucosa and avoids first-pass metabolism and any enzymatic degradation in the stomach. Thus, the buccal route of administration increases absorption and reduces any gastrointestinal adverse effects associated with taking tablets orally. The traditional route of administration for semaglutide for weight loss is via subcutaneous injection. However, the revolutionary transmucosal buccal film has provided an alternative method to deliver the semaglutide, which is both practical and convenient. This method of drug delivery particularity will suit that cohort of needle-phobic patients. The APC Labs Semaglutide Transmucosal Film is compounded as a green film and is packaged in a strip of ten in a crystal PET transparent blister.
How to use the Semaglutide transmucosal buccal film?
The transmucosal buccal film delivers the drug through the buccal mucosa and straight into the bloodstream. When we talk about buccal mucosa we are referring to the inside of the mouth. But unlike regular tablets and capsules, which you swallow, you attach the film to the inside of the mouth. As soon as it makes contact with the inside of the cheek, it sticks to immediately and begins to dissolve.
The following list of the steps involved in applying a film:
1. Before removing the film, wash your hands thoroughly and dry them to ensure that the film doesn’t stick to your fingers.
2. Then carefully peel off the film and, with your fingertip, position it on the inside of the cheek.
3. You will feel that the film immediately sticks to the side of the mouth and starts to dissolve.
4. Try not to swallow any saliva while the film is dissolving. The whole purpose of buccal administration is to allow it to dissolve across the inner lining of the mouth into the bloodstream.
5. Only eat or drink something for up to an hour before and after applying the film.
6. The film should dissolve in less than two minutes and may leave a slight aftertaste, depending on your prescribed transmucosal film.
7. Remember to seal the plastic blister tray to prevent the film from being exposed to air, and either return it to the silver foil envelope or store it in a dark cupboard at room temperature.
To watch a video of how to apply the transmucosal buccal film, please click the following link or scan the
QR code.
SeSemaglutide QR Code
https://www.youtube.com/watch?v=-41LALqEhVc&t=2s
You should not swallow the transmucosal film. This medicine should not be crushed or cut in half.
Who should not take the Semaglutide transmucosal buccal film?
Hypersensitivity to the active substance or any excipients.
Warnings:
Semaglutide injection may potentially elevate the risk of developing tumours in the thyroid gland, including medullary thyroid carcinoma (MTC), a form of thyroid cancer. Laboratory studies involving animals administered semaglutide revealed tumour formation, though it remains uncertain whether this medication poses a similar risk in humans. Patients should be screened for a history of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Special warnings and precautions for useGastrointestinal effects
The utilisation of GLP-1 receptor agonists may be linked to gastrointestinal adverse reactions, potentially resulting in dehydration, which in rare instances may contribute to a decline in renal function. Patients should be informed about the potential risk of dehydration associated with gastrointestinal side effects and advised to take precautions to prevent fluid depletion.
Acute pancreatitis
Acute pancreatitis has been noted in association with using GLP-1 receptor agonists. Patients should be educated about the typical symptoms of acute pancreatitis. If pancreatitis is suspected, discontinuation of semaglutide is recommended; if confirmed, semaglutide should not be resumed. Caution is advised in patients with a history of pancreatitis.
Elevations in pancreatic enzymes alone, without other signs and symptoms of acute pancreatitis, do not indicate the condition.
For patients with diabetes
Semaglutide must not be used as a substitute for insulin in patients with diabetes.
Hypoglycaemia in patients with diabetes
Insulin and sulfonylureas are recognised for their potential to induce hypoglycaemia. Individuals receiving semaglutide alongside a sulfonylurea or insulin may face an elevated risk of hypoglycaemia. This risk can be mitigated by reducing the sulfonylurea or insulin dosage upon initiating treatment with a GLP-1 receptor agonist. It's important to note that the introduction of semaglutide 2.4 mg in patients treated with insulin has not been assessed.
Diabetic retinopathy in patients with type 2 diabetes
In individuals with diabetic retinopathy undergoing treatment with insulin and semaglutide, a heightened risk of diabetic retinopathy complications has been noted. While rapid enhancement in glucose regulation has been linked to the temporary worsening of diabetic retinopathy, other mechanisms cannot be discounted. Close monitoring and adherence to clinical guidelines are recommended for patients with diabetic retinopathy using semaglutide. However, there is no available data on the use of semaglutide 2.4 mg in patients with type 2 diabetes exhibiting uncontrolled or potentially unstable diabetic retinopathy.
Populations not studied
No experience exists in patients with congestive heart failure New York Heart Association (NYHA) class IV. There is limited experience in patients aged 75 years or more.
What are the side effects of the Semagltuide transmucosal buccal film?
Summary of the safety profile of licensed semaglutide
Across four phase 3a trials, 2,650 adult patients were treated with semaglutide 2.4 mg over 68 weeks. Consistent with other GLP-1 receptor agonists, gastrointestinal disorders such as nausea, diarrhoea, constipation, and vomiting were the most commonly reported adverse reactions.
The frequencies are derived from a pooled analysis of the phase 3a trials. Adverse reactions associated with semaglutide 2.4 mg are categorised by system organ class and frequency, with frequency categories defined as: Very common (? 1/10); common (? 1/100 to <1/10); uncommon (? 1/1,000 to <1/100); rare (? 1/10,000 to <1/1,000); very rare (<1/10,000).
Description of selected adverse reactionsGastrointestinal adverse reactions
During dose escalation, the events were most frequently reported. Over 68 weeks, nausea was observed in 43.9% of patients receiving semaglutide 2.4 mg (16.1% for placebo), diarrhoea in 29.7% (15.9% for placebo), and vomiting in 24.5% (6.3% for placebo). Most of these events were of mild to moderate severity and short duration. Constipation occurred in 24.2% of patients treated with semaglutide 2.4 mg (11.1% for placebo) and was generally mild to moderate in severity but of longer duration. Gastrointestinal events led to permanent discontinuation of treatment in 4.3% of patients.
Acute pancreatitis
In phase 3a clinical trials, the frequency of adjudication-confirmed acute pancreatitis reported was 0.2% for semaglutide 2.4 mg and less than 0.1% for placebo, respectively.
Acute gallstone disease/Cholelithiasis
Cholelithiasis occurred in 1.6% of patients treated with semaglutide 2.4 mg, and cholecystitis resulted in 0.6% of these patients.
Hair loss
Hair loss occurred in 2.5% of patients treated with semaglutide 2.4 mg and in 1.0% of patients treated with placebo. The events were primarily mild in severity, and most patients recovered while continuing treatment. Hair loss was reported more frequently in patients experiencing more significant weight loss (? 20%).
Increased heart rate
During the phase 3a trials, patients treated with semaglutide 2.4 mg exhibited a mean increase of 3 beats per minute (bpm) from a baseline mean of 72 bpm. The proportions of patients experiencing a maximum increase from baseline of ? 20 bpm/min at any timepoint during the treatment period were 26.0% in the semaglutide 2.4 mg group compared to 15.6% in the placebo group.
Immunogenicity
As is typical with medicinal products containing proteins or peptides, patients may generate antibodies following semaglutide treatment. However, the percentage of patients testing positive for anti-semaglutide antibodies at any time post-baseline was low (2.9%), and none of the patients developed anti-semaglutide neutralising antibodies or anti-semaglutide antibodies with endogenous GLP-1 neutralising effect by the end of the trial.
Hypoglycaemia in patients with type 2 diabetes
In STEP 2, clinically significant hypoglycaemia was noted in 6.2% (0.1 events/patient-year) of patients receiving semaglutide 2.4 mg, compared to 2.5% (0.03 events/patient-year) of patients receiving placebo. One episode (0.2% of subjects, 0.002 events/patient-year) was categorised as severe. The risk of hypoglycaemia was elevated when semaglutide 2.4 mg was used concomitantly with a sulfonylurea.
Diabetic retinopathy in patients with type 2 diabetes
In STEP 2, new onset or deterioration of diabetic retinopathy was observed in 4.0% of patients treated with semaglutide 2.4 mg, compared to 2.7% of patients receiving placebo.
Paediatric population
In a clinical trial involving adolescents aged 12 to under 18 years with obesity or overweight and at least one weight-related comorbidity, a total of 133 patients received semaglutide over 68 weeks. Overall, the frequency, type, and severity of adverse reactions in adolescents were similar to those observed in adults. Cholelithiasis was reported in 3.8% of patients treated with Semaglutide, compared to 0% of patients treated with a placebo. Additionally, no effects on growth or pubertal development were observed after 68 weeks of treatment.
Reporting of suspected adverse reactions
It is vital to report any suspected adverse reactions following the authorisation of the medicinal product. This facilitates ongoing monitoring of the product's benefit-to-risk ratio. Healthcare professionals are encouraged to report any suspected adverse reactions through the Yellow Card Scheme. Great Britain Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Does the Semaglutide transmucosal buccal interact with any other medicines?
Like other GLP-1 receptor agonists, semaglutide may slow gastric emptying and potentially affect the absorption of concurrently administered oral medications. However, no clinically significant impact on gastric emptying rate was noted with semaglutide 2.4 mg. In clinical pharmacology trials investigating the influence of semaglutide 1.0 mg on the absorption of concomitant oral medications at a steady state, no clinically relevant drug interactions with semaglutide were observed based on the evaluated medications. Consequently, no dosage adjustment is necessary when co-administering with semaglutide.
Oral contraceptives
Semaglutide is not expected to reduce the efficacy of oral contraceptives. Clinical studies have shown that semaglutide does not significantly alter the overall exposure of ethinylestradiol and levonorgestrel when coadministered with an oral contraceptive combination product (containing 0.03 mg ethinylestradiol/0.15 mg levonorgestrel). Specifically, exposure to ethinylestradiol remained unaffected, while a 20% increase in levonorgestrel exposure at steady state was observed. There were no changes in Cmax for either compound.
Atorvastatin
Following a single dose of atorvastatin (40 mg), semaglutide did not affect the overall exposure to atorvastatin. However, the maximum concentration (Cmax) of atorvastatin decreased by 38%, which was deemed not clinically relevant.
Digoxin
Semaglutide did not alter the overall exposure or maximum concentration (Cmax) of digoxin after a single digoxin dose (0.5 mg).
Metformin
Semaglutide did not affect the overall exposure or maximum concentration (Cmax) of metformin after administering a dose of 500 mg twice daily for 3.5 days.
Warfarin
Semaglutide did not alter the overall exposure or maximum concentration (Cmax) of both R- and S-warfarin after a single dose of warfarin (25 mg). Furthermore, the pharmacodynamic effects of warfarin, as measured by the international normalised ratio (INR), were not clinically significantly affected.
Paediatric population
Interaction studies have only been performed in adults.
Semaglutide 1mg transmucosal buccal film FAQs
What is Semaglutide 1 mg transmucosal buccal film?
Semaglutide 1 mg Transmucosal film is formulated for buccal administration. It is dispensed in a plastic blister tray containing ten films. The film is mucoadhesive, meaning that when it comes into contact with the inside of the mouth, it immediately adheres to it, where it then dissolves rapidly, allowing the active ingredients to be transferred across the buccal mucosa. This allows direct absorption into the bloodstream, meaning that more active ingredients will reach the circulation.
How does the transmucosal buccal film enhance semaglutide delivery?
Semaglutide Transmucosal Buccal Film is an advanced formulation that allows rapid absorption into the bloodstream, bypassing first-pass metabolism, meaning more active ingredients reach their site of action. The mucoadhesive film is specially formulated to adhere upon contact with the inside of the mouth, where it begins to dissolve rapidly.
The semaglutide transmucosal film can be stored at room temperature, eliminating cold chain requirements. The buccal drug delivery route presents an appealing option for patients averse to needles, offering ease of administration without the need for water.
What are the benefits of using a transmucosal buccal film for Semaglutide?
Transmucosal buccal film administration of semaglutide offers several benefits, including the potential for faster onset of action, avoidance of gastrointestinal degradation, and reduced impact of hepatic first-pass metabolism. This can result in improved medication bioavailability. Additionally, the transmucosal buccal film route is convenient for patients with difficulty swallowing tablets or capsules.
How should I use the Semaglutide Transmucosal buccal film?
Wash hands before removing the film from the blister tray and placing it on the inside of the cheek. Once in position, the film’s mucoadhesive properties allow it to stick firmly in place. It then begins to dissolve rapidly, crossing the buccal mucosa into the bloodstream. Try not to swallow any saliva while the film is dissolving to ensure that most of the drug is able to cross the buccal mucosa. Avoid eating or drinking for half an hour to one hour before and after applying the film.
Can I eat or drink immediately after taking the Semaglutide Transmucosal buccal film?
It is generally recommended to wait up to half an hour after applying the transmucosal buccal film before eating or drinking. This allows the medication to be fully absorbed through the mucosa.
Is Semaglutide Transmucosal buccal film suitable for paediatric patients?
No, the semaglutide transmucosal film is suitable only for adults aged 18 years and over.
What should I do if I miss a dose of Semaglutide Transmucosal buccal film?
If a dose of Semaglutide Transmucosal buccal film is missed, take it as soon as remembered. However, if the next dose is approaching, skip the missed dose and continue with the regular dosing schedule. Avoid doubling the dose to compensate for the missed one. It's important to seek personalised advice from your healthcare provider regarding missed doses.
How should I store the Semaglutide Transmucosal buccal film?
Store the Semaglutide Transmucosal buccal film Suspension at room temperature, away from direct light and heat. Keep the plastic blister tray tightly sealed when not in use. Refer to the product label or consult your pharmacist for specific storage instructions.
What are the potential side effects of Semaglutide Transmucosal buccal film?
Like all medications, Semaglutide Transmucosal buccal film may lead to side effects. Common ones may include nausea, vomiting, diarrhoea, and abdominal pain. Should you encounter severe or persistent side effects, it's essential to reach out to your healthcare provider promptly. For a comprehensive breakdown of the side effects of semaglutide transmucosal film, please read the prescriber/patient information leaflet.
Can Semaglutide Transmucosal buccal film be used with other medications?
It is important to discuss all medications, supplements, and over-the-counter drugs you are taking with your healthcare provider to ensure that the Semaglutide Transmucosal buccal film is compatible. Some medicines may interact with Semaglutide, affecting its efficacy or increasing the risk of side effects. Also, refer to the side effects section above and read the prescriber/patient information leaflet.
What is the beyond-use-date (BUD) for Semaglutide Transmucosal buccal film?
The beyond-use date for Semaglutide Transmucosal buccal film is 180 days from the date of manufacture and will be printed on the dispensing label.
References:
C Koliaki, J. Doupis Incretin-based therapy: a powerful and promising weapon in the treatment of type 2 diabetes mellitus. Diabetes Ther, 2 (2) (2011), pp. 101-121
YS Lee, HS. Jun Anti-diabetic actions of glucagon-like peptide-1 on pancreatic beta-cells. Metabolism, 63 (1) (2014), pp. 9-19
Donnelly. The structure and function of the glucagon-like peptide-1 receptor and its ligands. Br J Pharmacol, 166 (1) (2012), pp. 27-41
T Vilsbøll, H Agersø, T Krarup, J. Holst. Similar elimination rates of glucagon-like peptide-1 in obese type 2 diabetic patients and healthy subjects, J Clin Endocrinol Metab, 88 (1) (2003), pp. 220-224
Holst, The physiology of glucagon-like peptide 1, Physiol Rev, 87 (4) (2007), pp. 1409-1439
LB Knudsen, J. Lau, The discovery and development of liraglutide and semaglutide. Front Endocrinol (Lausanne), 10 (2019), p. 155
J Lau, P Bloch, L Schäffer, I Pettersson, J Spetzler, J Kofoed, et al. Discovery of the once-weekly glucagon-like peptide-1 (GLP-1) analogue semaglutide.J Med Chem, 58 (18) (2015), pp. 7370-7380
AJ Ahmann, M Capehorn, G Charpentier, F Dotta, E Henkel, I Lingvay, et al.Efficacy and safety of once-weekly semaglutide versus exenatide ER in subjects with type 2 diabetes (SUSTAIN 3): a 56-week, open-label, randomised clinical trial. Diabetes Care, 41 (2) (2018), pp. 258-266
J Blundell, G Finlayson, M Axelsen, A Flint, C Gibbons, T Kvist, et al. Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity. Diabetes Obes Metab, 19 (9) (2017), pp. 1242-1251
S Gabery, CG Salinas, SJ Paulsen, J Ahnfelt-Rønne, T Alanentalo, AF Baquero, et al..Semaglutide lowers body weight in rodents via distributed neural pathways. JCI Insight, 5 (6) (2020)
M Friedrichsen, A Breitschaft, S Tadayon, A Wizert, D. Skovgaard. The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. Diabetes Obes Metab, 23 (3) (2021), pp. 754-762
Summary of Product Characteristics Updated 03-04-2024 | Limited.This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
