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Overview of oral solid dose (OSD) dosage manufacturing, specifically film coated tablets, complex modified release tablets & controlled substances.

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01 AJES Pharmaceuticals, LLC

02 ANFARM HELLAS S.A.

03 AbbVie Contract Manufacturing

04 Adare Pharma Solutions

05 Appco Pharmaceutical Corp

06 Athena Pharmaceutiques

07 Aurigene Pharmaceutical Services

08 Avara Pharmaceutical Services

09 Axxelent Pharma Science

10 BILCARE GCS

11 Bioindustria L.I.M. Spa

12 Biological E

13 Biophore India Pharmaceuticals Pvt Ltd

14 Bioplus Life Sciences

15 Bliss Gvs Pharma Ltd

16 Bora Pharmaceuticals

17 Brooks laboratories Limited

18 Catalent Pharma Solutions

19 Chanelle Medical

20 Delorbis Pharmaceuticals

21 Delpharm Group

22 Douglas CDMO

23 Ethypharm

24 Eurofins CDMO

25 Famar

26 Farbe Firma

27 Fareva

28 Fermion Oy

29 Flagship Biotech International Pvt. Ltd

30 Fresenius Kabi Austria

31 GALIEN LPS

32 Gensenta Pharmaceuticals

33 Glatt Pharmaceutical Services

34 Gracure Pharmaceuticals Limited

35 HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO., LTD.

36 ICE Pharma

37 Innopharmax

38 JGL d.d

39 JSC Olainfarm

40 Juniper Pharmaceuticals, Inc

41 LGM Pharma

42 Laboratoires Galéniques Vernin

43 Lecifarma

44 Madras Pharmaceuticals

45 Mikart

46 Mission | CDMO

47 Mithra CDMO

48 Nanjing Dorra Pharmaceutical Technology Co.,Ltd

49 ORIT LABS LLC

50 Octavius Pharma Pvt. Ltd

51 One Pharma

52 Orchid Pharma

53 Orofino Pharmaceuticals Group

54 PENMIX LTD.

55 PHARMEAL LABORATOIRES

56 PSR Pharma Science and Research

57 Pfizer CentreOne

58 Pierre Fabre

59 Piramal Pharma Solutions

60 Polfa Tarchomin

61 Prague Scientific

62 Priyans Drugs

63 Quotient Sciences

64 R-Pharm Germany GmbH

65 Recipharm AB

66 Renejix

67 Ropack Inc

68 S.C. Rompharm Company SRL

69 Saneca Pharmaceuticals

70 Santa S.A

71 Sharp

72 Sirio Pharma Co. Ltd

73 Skyepharma

74 Societal CDMO

75 Sofarimex

76 Temad Co

77 Tianjin Hankang Pharmaceutical Biotechnology

78 TriRx Pharmaceutical Services

79 Unique Biotech Limited

80 WellSpring Consumer Healthcare

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Overview of oral solid dose (OSD) dosage manufacturing, specifically film coated tablets, complex modified release tablets & controlled substances.

Q1. Tablets, what are they and what are the different types available in the pharmaceutical industry?

Pharmaceutical tablets are solid oral dosage forms prepared by compressing a drug (API) with or without diluents. Tablets function as unit doses that deliver the desired quantity of active pharmaceutical ingredients (API) to the end consumer with unparalleled accuracy. 

There are various dosage forms including liquids, sprays, injectables, creams, suppositories, etc. However, the preferred dosage form by a large margin, remains to be oral solid dose (OSD) dosage forms. Commercial drug product manufacturing trends show that oral solid dose (OSD) dosage forms continue to play a major role in the pharmaceutical contract manufacturing and CDMO industry, representing about 70% of the market. 

Oral solid dosage outsourcing trends further reveal that despite the increasing types of biologics, oral solid forms such as tablets & capsules remain dominant in the commercial market. The ease of administration, identification, and relatively better taste assert pharmaceutical oral solid dosage forms as one of the leading modes of drug administration.

Pharmaceutical solid oral dosage forms are preferred formulations for drug delivery. Tablets have the greatest dose precision, lowest content variability, lowest cost, and various other favorable qualities that make them a desired choice amongst pharma CMOs and CDMOs offering formulation development services (contract development services).

 

Furthermore, tablets offer flexibility as oral formulations and are available as the following types (amongst others):

- Film coated tablets

- Enteric coated tablets

- Buccal tablets

- Extended release tablets

- Complex modified release tablets

- Sustained release tablets

- Effervescent tablets 

- Chewable tablets 

- Compressed tablets 

- Sugar-coated tablets

Q2. How are tablets formulated and what are the manufacturing aspects of film coated tablets?

Tablet formulation development and manufacturing is a stylized process. Each Pharma CMO and CDMO (contract development and manufacturing organization) uses their own pharmaceutical formulation development and manufacturing methodology. Some use the systematic design of experiments (DOE) approach, some test one variable at a time, and many use a combination of the two. 

 

The pharmaceutical formulation development and manufacturing of tablets is completed in the following steps:

Step 1. Preformulation Studies: Preformulation is the stage of development in the pharmaceutical industry, during which physicochemical properties of drug substances are characterized and established. 

This could provide important information for formulation design or anticipate the needs for molecular modifications. Every drug has intrinsic chemical and physical properties which need to be considered before the formulation development and manufacturing of pharmaceutical drug products such as film coated drug products.

Step 2. Dispensing: The first step in tablet development and formulation, after preformulation studies have been conducted and appropriate oral formulations have been chosen, is called dispensing. Dispensing involves weighing all the ingredients in tablets accurately to ensure desired API & excipient amounts in the tablet formulations. 

Step 3. Sizing: The second step in tablet formulation development is known as sizing. During sizing the active ingredients and pharmaceutical excipients used in tablet formulations are broken down to a finely divided forms, to augment flow properties and enable easier mixing of ingredients.

Step 4. Powder Blending: Powder blending uses cutting edge technologies to mix powders and achieve homogeneous mixtures. This step of tablet development and formulation gives blend uniformity and distributes lubricants evenly in the resulting powdered mixture. 

Step 5. Granulation: Most fine pharmaceutical compounds require the formulation development process known as granulation, offered by pharmaceutical CDMOs to improve flow properties and processing properties prior to tableting. Granulation can be divided into two types: dry granulation and wet granulation. 

Step 6. Drying & Dry Screening: If the wet granulation route of tablet formulation development is used in the previous step, then it is followed by drying and dry screening. Dry screening in tablet development refers to passing the dried granules throug