PT 141 Tablets

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PT 141 Tablets (Bremelantide) is a medication used to treat sexual dysfunction. Its core mechanism is to regulate the release of sex related neurotransmitters by activating the melanocortin receptor (MC4R) in the central nervous system. PT 141 is a cyclic peptide drug containing seven amino acids and belongs to the class of melanocortin receptor agonists. Its chemical structure is similar to alpha melanocyte stimulating hormone (α - MSH), but after modification, it has higher selectivity for MC4R receptors and does not cause skin pigmentation. Due to the large molecular weight of PT 141 (approximately 1025 daltons), it is easily degraded by gastrointestinal enzymes after oral administration and has extremely low bioavailability. Therefore, it mainly exists in the form of injections on the market at present. It can promote the release of dopamine, enhance reward and motivation related neural activity, thereby increasing libido. Unlike PDE-5 inhibitors such as sildenafil (such as Viagra), PT 141 does not act on the vascular system and does not cause relaxation of smooth muscle and increased blood flow in the corpus cavernosum of the penis. Therefore, PT 141 is mainly used to treat sexual dysfunction rather than erectile dysfunction.

PT 141 COA

PT 141 (Bremelantide) is an artificially synthesized alpha melanocyte stimulating hormone analog primarily used for the treatment of sexual dysfunction. The production of PT 141 Tablets involves multiple complex steps, including raw material synthesis, formulation process development, quality control, etc. The following is its detailed content:

The raw material synthesis of PT 141 mainly adopts solid-phase synthesis method, using amino acids protected by Fmoc (fluorenylmethoxycarbonyl) as raw materials, and obtaining the target product through steps such as coupling, deprotection, and cyclization. The following are the main steps in the synthesis of PT 141 API:

Resin preparation

Choose a suitable solid-phase resin, such as Rink HMBA-AM Resin or Wang resin, and couple the first amino acid (such as Fmoc Lys (Boc) - OH) onto the resin through a chemical reaction to obtain a resin with the first amino acid.

Gradually coupling

According to the amino acid sequence of PT 141, sequentially protect other amino acids protected by Fmoc (such as Fmoc-Trp(Boc)-OH,Fmoc-Arg(Pbf)-OH,Fmoc-D-Phe-OH,Fmoc-His(Trt)-OH,Fmoc-Asp(OtBu)-OH,Fmoc-Nle-OH) Coupling onto resin. Each coupling reaction requires the addition of coupling reagents (such as DIC, HOBt, etc.) and bases (such as DIEA), and is carried out at an appropriate temperature and time. After coupling is completed, it is necessary to use a deprotection reagent (such as a 20% piperidine DMF solution) to remove the Fmoc protecting group in order to proceed to the next step of coupling.

Cyclization

After completing the conjugation of all amino acids, the linear peptide chain needs to be cyclized between Asp and Lys to form a cyclic heptapeptide structure. The cyclization reaction is usually carried out in a lysis buffer containing reagents such as trifluoroacetic acid (TFA), which can simultaneously remove the protecting groups of amino acid side chains and resin. The cyclization reaction requires the control of appropriate conditions, such as temperature, time, and reagent concentration, to ensure the complete progress of the cyclization reaction.

Purification and drying

After the cyclization reaction is completed, the crude product is purified by reverse phase high-pressure liquid chromatography (RP-HPLC) to remove impurities and unreacted raw materials. The purified product was subjected to freeze-drying to obtain the raw material of PT 141.

 

During the synthesis process of active pharmaceutical ingredients, the following points should be noted:

The production of PT 141 Tablets requires mixing the raw materials with appropriate excipients, and making tablets through processes such as granulation and compression. The following are the main steps of its formulation process:

1

 

Preparation of raw materials and excipients

Weigh PT 141 raw material and excipients (such as fillers, disintegrants, lubricants, etc.) in a certain proportion and prepare for use. The selection of excipients needs to consider their impact on drug solubility, stability, and bioavailability.

2

 

Pre mixed

Pre mix the raw material with some excipients (such as fillers) in a mixer to evenly disperse the drug in the excipients. The time and speed of pre mixing need to be adjusted according to the properties of the material to ensure uniform mixing.

3

 

Granulation

Add adhesive solution (such as hydroxypropyl methylcellulose aqueous solution) to the pre mixed material and form wet granules through a wet granulation mechanism. During the granulation process, it is necessary to control the amount of adhesive, liquid addition speed, and stirring time to obtain the appropriate particle size and shape. Wet particles are dried (such as fluidized bed drying) to obtain dry particles.

4

 

Whole grain and total mixture

Dry particles are processed by a granulator to remove oversized or undersized particles, resulting in uniform particle size. The whole granules are mixed with the remaining excipients (such as disintegrants, lubricants, etc.) in the mixer to evenly distribute the excipients in the granules.

5

 

compression

Add the mixed particles into the tablet press, and press them into tablets of a certain weight and hardness by adjusting the pressure and filling amount of the tablet press. During the tablet compression process, it is necessary to control the weight difference, hardness, and brittleness of the tablets to ensure their quality.

6

 

Coating (optional)

Tablets can be coated as needed, such as film coating or enteric coating. Coating can improve the appearance, taste, and stability of tablets, or control the release site of drugs. The coating process requires controlling parameters such as the concentration of the coating solution, spraying speed, and drying temperature.

In the process of tablet formulation, the following points should be noted:

In the production process of PT 141 Tablets, strict quality control is required to ensure the quality and safety of the product. Quality control includes raw material quality control, intermediate quality control, and finished product quality control.

In the process of quality control, it is necessary to establish a sound quality management system, formulate strict quality standards and operating procedures, strengthen monitoring and inspection of the production process, and ensure the quality and safety of products.

With the continuous advancement of pharmaceutical formulation technology, the production process of PT-141 tablets will also continue to develop and improve. Future development directions include:

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